Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202007868402718 Date of Approval: 14/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Study to Evaluate the Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Mycobacterium Tuberculosis Infection in Newborn Infants at multiple sites
Official scientific title A Multicenter, Phase III, Double-blind, Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Mycobacterium Tuberculosis Infection in Newborn Infants
Brief summary describing the background and objectives of the trial The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation) to assess the efficacy, safety and immunogenicity of VPM1002 against Mtb infection. The objectives of this trial are to demonstrate that VPM1002 is non-inferior to BCG SII in providing protection against incident Mycobacterium tuberculosis (Mtb) infection and to demonstrate that VPM1002 is superior to BCG SII in providing protection against incident Mtb infection.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VPM1002
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 31/10/2020
Actual trial start date 09/11/2020
Anticipated date of last follow up 31/12/2025
Actual Last follow-up date 30/10/2024
Anticipated target sample size (number of participants) 6940
Actual target sample size (number of participants) 6898
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group VPM1002 0.05 ml will be administered intradermally Single dose VPM1002 is a formulated, lyophilized cake of live recombinant Mycobacterium bovis rBCGΔureC::hly;VPM1002. One vial contains 2-8 x 10e6 CFU of the IP. VPM1002 is the active pharmaceutical ingredient. After reconstitution with water for injection, 1 dose (0.05 ml) contains: VPM1002, live, 1-4 x 10e5 CFU. Store at +2°C to +8°C. Protect from direct sunlight. Diluent: 1 ml of Water for injection/vial. The diluent should not be frozen, but should be kept cool. 3470
Control Group BCG SII 0.05 ml will be administered Intradermally in infants under one year old. Single Dose BCG SII is a live freeze-dried vaccine derived from attenuated strain of Mycobacterium bovis (Bacillus Calmette Guerin Moscow strain 361- I) used for the prevention of TB. COMPOSITION: Live, attenuated BCG Vaccine (Bacille Calmette Guerin Strain) 1 dose (0.05 ml) contains: BCG SII, live, 1-4 x 10e5 CFU Reconstitute with Sodium Chloride Injection Dose : 0.05 ml will be administered Intradermally in infants under one year old. Diluent: 1 ml of Sodium Chloride for injection/vial Injection. The diluent should not be frozen,but should be kept cool. 3470 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A. Maternal 1. Age: 18 years or older at screening 2. No symptoms or signs of active TB at the time of participant’s enrolment. 3. Parent / guardian who intends to remain in the area with the child and should be reachable by phone during the trial period. B. Infant 1. Healthy male or female newborn infant. 2. Birth weight of at least 2,300 g. 3. Test negative for HIV by PCR at screening if born to an HIV-infected mother. A. Maternal 1. Any reported or suspected substance abuse during pregnancy. 2. House-hold contact with active TB (defined as residing in the same house as an individual with active TB) within the 3 months prior to enrolment. B. Infant 1. Fever at the time of enrolment. 2. Clinically suspected sepsis. 3. Any malignant condition. 4. Any clinically significant severe congenital malformation, which may interfere with the evaluation of the safety, efficacy or immunogenicity of the vaccine. New born: 0 Day-1 Month 0 Day(s) 14 Day(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/11/2019 Stellenbosch University Health Reaserch Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Tygerberg Campus, Francie van Zyl Avenue Tygerberg 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/02/2020 Sefako Makgatho University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Molotlegi Street, Ga-Rankuwa Medunsa 0204 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/10/2019 University of Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Suite 189, Private Bag x2600, Houghton, South Africa Houghton 2041 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/03/2020 University of Cape Town Human Reasarch Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Floor E53, Room 46 Old Main Building Groote Schuur Hospital Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/01/2020 Comite d Ethique Institutionnel du CERMEL
Ethics Committee Address
Street address City Postal code Country
BP 242 Lambarene BP1437 Libreville Gabon Libreville 1437 Gabon
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/01/2020 Comite National d Ethique pour la Recherche
Ethics Committee Address
Street address City Postal code Country
B.P. 2217 Libreville Gabon Libreville 2217 Gabon
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/12/2019 Ifakara Health Institute Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
P. O. BOX 78 373 Dar es Salaam, Tanzania Dar Es Salaam 78373 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/06/2020 National Health Research Ethics Review Committee National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
2448 Ocean Road, P. O. Box 9653, Dar Es Salaam Tanzania Dar Es Salaam 9653 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/04/2020 Kenya Medical Research Institute Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
P.O. BOX 54840 00200 OFF MBAGATHI ROAD, NAIROBI HOUSE NUMBER 8, KEMRI HEADQUARTERS Nairobi 54840 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/07/2020 Higher Degrees Research and Ethics Committee College of Health Sciences School of Public Health Makerere University
Ethics Committee Address
Street address City Postal code Country
P.O.Box 7072, Kampala, Uganda Kampala 7072 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/10/2020 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Rd P.O. BOX 6884 Kampala Uganda Kampala 6884 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/01/2021 Mbeya Medical Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mbeya Zonal Referral Hospital Mbeya P.O. Box 419 Tanzania Mbeya 419 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. To demonstrate that VPM1002 is non-inferior to BCG SII in providing protection against incident Mycobacterium tuberculosis (Mtb) infection. 2. To demonstrate that VPM1002 is superior to BCG SII in providing protection against incident Mtb infection. Through out the study duration
Secondary Outcome 1. To compare the safety and tolerability profile of VPM1002 and BCG SII administered as a single dose to newborn infants. 2. To compare the efficacy of VPM1002 versus BCG SII in terms of the protective effects against tuberculosis (TB) disease. 3. To compare the efficacy of VPM1002 versus BCG SII in terms of the protective effects against sustained Mtb infection. Throughout the study period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ifakara Health Institute IHI Mwanyamala District Hospital P.O. Box 61665 Kinondoni district, Dar es Salaam, Tanzania Dar es Salaam 61665 Tanzania
Kenya Medical Research Institute Center for Respiratory Disease Research KEMRI CRDR KEMRI/CRDR Nairobi KNH Complex, Behind Government Chemist P.O. Box 47855-00100 Nairobi, Kenya Nairobi 47855-001 Kenya
Medical Research Council Uganda Virus Research Institute and London School of Hygiene and Tropical Medicines Uganda Research Unit MRC UVRI and LSHTM Entebbe General Hospital and Entebbe Mother and Baby Study clinic, Entebbe, Uganda Entebbe Uganda
Makerere University CISMAC School of Public Heath, College of Health Sciences Makarere University, P.O Box 7062 Kampala Uganda Kampala 7062 Uganda
Respiratory and Meningeal Pathogens Research Unit RMPRU 1st floor, Central-West wing, Nurses residence Chris Hani Baragwanath Hospital Chris Hani Road, Soweto PO Bertham, South Africa Soweto 2013 South Africa
South African Tuberculosis Vaccine Initiative SATVI Brewelskloof Hospital, Haarlem Street, Worcester, 6850, South Africa Worcester 6850 South Africa
Family Centre for Research with Ubuntu FAMCRU Tygerberg Childrens Hospital, Ward J8 Francie van Zijl Avenue Cape Town, 7505 South Africa Cape Town 7505 South Africa
Mecru Clinical Research Unit MeCRU Sefako Makgatho Health Science University Medunsa 0204 South Africa Medunsa 0204 South Africa
Centre de Recherches Medicales de Lambarene CERMEL CERMEL, BP 242, Lambarene, Gabon Lambarene Gabon
Kenya Medical Research Institute Center for Respiratory Disease Research KEMRI CRDR KEMRI/CRDR At Siaya Country Referrall Hospital P.O. Box 144, Siaya, Kenya Siaya 144 Kenya
Empilweni Services and Research Unit ESRU Rahima Moosa Mother and Child Hospital, Cnr Oudtshoorn and Fuel Road, Coronationville, Johannesburg, 2093, South Africa Johannesburg 2093 South Africa
Mbeya Medical Research Center NIMR MMRC Hospital Hill Road, P.O.Box 2410, Mbeya - Tanzania Mbeya 2410 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership EDCTP Anna van Saksenlaan 51 2593 HW The Hague, The Netherlands Hague 2593 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Serum Institute of India Private Limited 212/2, Off Soli Poonawalla Road, Hadapsar, Pune 411028, Maharashtra, India Pune 411028 India Vaccine manufacturing company
COLLABORATORS
Name Street address City Postal code Country
Serum Life Science Europe GmbH Ahrensburger Strasse 1 30659 Hannover Germany Hannover 30659 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaun Barnabas barnabas@sun.ac.za +27219384219 Family Centre for Research with Ubuntu FAMCRU Tygerberg Childrens Hospital, Ward J8, Francie van Zijl Avenue, Cape Town, 7505, South Africa
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Principal Investigator
Role Name Email Phone Street address
Public Enquiries Sajjad Desai sajjad.desai@seruminstitute.com +902026602781 Serum Institute of India Pvt. Ltd., 212/2, Off Soli Poonawalla Road, Hadapsar, Pune 411028, Maharashtra,India
City Postal code Country Position/Affiliation
Pune 411028 India Deputy Medical Director
Role Name Email Phone Street address
Scientific Enquiries Prasad Kulkarni drpsk@seruminstitute.com +912026602384 Serum Institute of India Pvt. Ltd., 212/2, Off Soli Poonawalla Road, Hadapsar, Pune 411028, Maharashtra,India
City Postal code Country Position/Affiliation
Pune 411028 India Medical Director
Role Name Email Phone Street address
Principal Investigator Victoria Nankabirwa nankabirwav@gmail.com +256755757460 School of Public Heath, College of Health Sciences Makarere University, P.O Box 7062 Kampala Uganda
City Postal code Country Position/Affiliation
Kampala 7062 Uganda Principal Investigator
Role Name Email Phone Street address
Principal Investigator Ayola Akim Adegnika aadegnika@gmail.com +24107989191 Centre de Recherches Mdicales de Lambarn CERMEL, BP 242, Lambarene, Gabon
City Postal code Country Position/Affiliation
Lambarene Gabon Principal Investigator
Role Name Email Phone Street address
Principal Investigator Francis Mhimbira fmhimbira@ihi.or.tz +255754291657 Ifakara Health Institute IHI Mwanyamala District Hospital, P.O. Box 61665, Kinondoni district, Dar es Salaam, Tanzania
City Postal code Country Position/Affiliation
Dar es Salaam 61665 Tanzania Principal Investigator
Role Name Email Phone Street address
Principal Investigator Videlis Nduba vnduba@gmail.com +254724522474 KEMRI CRDR Nairobi KNH Complex Behind Government Chemist, P.O. Box 47855-00100, Nairobi, Kenya and KEMRI/CRDR Siaya at Siaya Country Referral Hospital, P.O. Box 144, Siayu, Kenya
City Postal code Country Position/Affiliation
Nairobi 47855 Kenya Principal Investigator
Role Name Email Phone Street address
Principal Investigator Matsontso Mathebula matsontso.mathebula@smu.ac.za 00270125215714 Mecru Clinical Research Unit MeCRU, Sefaka Makgatho Health Science University, Medunsa, 0204, South Africa
City Postal code Country Position/Affiliation
Medunsa 0204 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Megan Jane Dempster megan.dempster@wits-vida.org +27836472827 Respiratory and Meningeal Pathogens Research Unit RMPRU, 1st floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Soweto PO Bertsham, 2013, South Africa
City Postal code Country Position/Affiliation
Soweto 2013 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Angelique Kany Kany Luabeya angelique.luabeya@uct.ac.za +27233465400 South African Tuberculosis Vaccine Initiative SATVI Brewelskloof Hospital, Haarlem Street, Worcester, 6850, South Africa
City Postal code Country Position/Affiliation
Worcester 6850 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Anne Wajja anne.wajja@mrcuganda.org 00256778103960 Plot 51-59, Nakiwogo Road, Entebbe, Uganda
City Postal code Country Position/Affiliation
Entebbe Uganda Principal Investigator
Role Name Email Phone Street address
Principal Investigator Issa Sabi isabi@nimr-mmrc.org +255252503364 NIMR-Mbeya Medical Research Center Hospital Hill Road, P.O.Box 2410, Mbeya - Tanzania
City Postal code Country Position/Affiliation
Mbeya 2410 Tanzania Principal Investigator
Role Name Email Phone Street address
Principal Investigator Megan Jane Dempster megan.dempster@wits-vida.org +27836472827 Rahima Moosa Mother and Child Hospital ESRU Cnr Oudtshoorn and Fuel Road, Coronationville, Johannesburg, 2093, South Africa
City Postal code Country Position/Affiliation
Johannesburg 2093 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Shaun Barnabas barnabas@sun.ac.za +27219384219 Family Centre for Research with Ubuntu FAMCRU Tygerberg Childrens Hospital, Ward J8, Francie van Zijl Avenue, Cape Town, 7505, South Africa
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Megan Jane Dempster megan.dempster@wits-vida.org +27836472827 Respiratory and Meningeal Pathogens Research Unit RMPRU, 1st floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Soweto PO Bertsham, 2013, South Africa
City Postal code Country Position/Affiliation
Soweto 2013 South Africa Principal Investigator
Role Name Email Phone Street address
Principal Investigator Megan Jane Dempster megan.dempster@wits-vida.org +27836472827 Rahima Moosa Mother and Child Hospital ESRU Cnr Oudtshoorn and Fuel Road, Coronationville, Johannesburg, 2093, South Africa
City Postal code Country Position/Affiliation
Johannesburg 2093 South Africa Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data (IPD) listing including demographic data, safety data listing will be shared. Clinical Study Report Within 2 years of study completion IPD will be sared based on controlled access data type.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 27/10/2020 Anticipated dates are updated. 10 Jun 2020 31 Oct 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 18/10/2021 Actual trial start Date updated 09 Nov 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 27/10/2020 Anticipated dates are updated. 10 Jun 2025 30 Sep 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 18/10/2021 Anticipated data of last follow up. 30 Sep 2023 30 Nov 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 04/08/2023 Anticipated Date of Last Follow up updated. 30 Nov 2022 31 Dec 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 04/08/2023 Study completion date updated. 12 Dec 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 04/08/2023 Completion date updated. 12 Dec 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 05/02/2025 Completion date is updated as per current study status. 30 Oct 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 04/08/2023 Final No. of Participants updated. 6940
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 04/08/2023 Final No. Of Participants updated to 6898. 6940 6898
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 16/04/2021 Recruiting Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 04/08/2023 Recruitment completed. Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 04/08/2023 Recruitment status updated. Completed Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 05/02/2025 Recruitment in the study is completed. Closed to recruitment,follow-up continuing Completed
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 05/02/2025 Recruitment in the study is completed. Completed Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 05/02/2025 Recruitment in the study is completed. Closed to recruitment,follow-up continuing Completed
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 05/02/2025 Recruitment in the study is completed. Closed to recruitment,follow-up continuing Completed
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 06/02/2025 Recruitment Status is updated Completed Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 06/02/2025 Recruitment Status is updated as per current study status. Closed to recruitment,follow-up continuing Completed
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 18/10/2021 New site added MeCRU Clinical Research Unit, Sefako Makgatho Health Science University Medunsa 0204 South Africa, Pretoria, 0204, South Africa Mecru Clinical Research Unit MeCRU, Sefako Makgatho Health Science University Medunsa 0204 South Africa, Medunsa, 0204, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/12/2020 Study site name updated for better clarity Ifakara Health Institute, Mwanyamala District Hospital P.O. Box 61665 Kinondoni district, Dar es Salaam, Tanzania, Dar es Salaam, 61665, Tanzania Ifakara Health Institute IHI, Mwanyamala District Hospital P.O. Box 61665 Kinondoni district, Dar es Salaam, Tanzania, Dar es Salaam, 61665, Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/12/2020 Study site name updated. Kenya Medical Research Institute Center for Respiratory Disease Research, KEMRI/CRDR Nairobi KNH Complex, Behind Government Chemist P.O. Box 47855-00100 Nairobi, Kenya, Nairobi, , Kenya Kenya Medical Research Institute Center for Respiratory Disease Research KEMRI CRDR, KEMRI/CRDR Nairobi KNH Complex, Behind Government Chemist P.O. Box 47855-00100 Nairobi, Kenya, Nairobi, , Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/12/2020 Postal code updated Kenya Medical Research Institute Center for Respiratory Disease Research KEMRI CRDR, KEMRI/CRDR Nairobi KNH Complex, Behind Government Chemist P.O. Box 47855-00100 Nairobi, Kenya, Nairobi, , Kenya Kenya Medical Research Institute Center for Respiratory Disease Research KEMRI CRDR, KEMRI/CRDR Nairobi KNH Complex, Behind Government Chemist P.O. Box 47855-00100 Nairobi, Kenya, Nairobi, 47855-001, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/12/2020 Site name updated Medical Research Council Uganda Virus Research Institute and London School of Hygiene and Tropical Medicines Uganda Research Unit, Entebbe General Hospital and Entebbe Mother and Baby Study clinic, Entebbe, Uganda, Entebbe, , Uganda Medical Research Council Uganda Virus Research Institute and London School of Hygiene and Tropical Medicines Uganda Research Unit MRC UVRI and LSHTM, Entebbe General Hospital and Entebbe Mother and Baby Study clinic, Entebbe, Uganda, Entebbe, , Uganda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 18/10/2021 Details updated Makerere University CISMAC Makarere, School of Public Heath, College of Health Sciences Makarere University, P.O Box 7062 Kampala Uganda, Kampala, 7062, Uganda Makerere University CISMAC, School of Public Heath, College of Health Sciences Makarere University, P.O Box 7062 Kampala Uganda, Kampala, 7062, Uganda
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/12/2020 Site name updated Respiratory and Meningeal Pathogens Research Unit, 1st floor, Central-West wing, Nurses residence Chris Hani Baragwanath Hospital Chris Hani Road, Soweto PO Bertham, South Africa, Soweto, 2013, South Africa Respiratory and Meningeal Pathogens Research Unit RMPRU, 1st floor, Central-West wing, Nurses residence Chris Hani Baragwanath Hospital Chris Hani Road, Soweto PO Bertham, South Africa, Soweto, 2013, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/12/2020 Site name updated University of Cape Town South African Tuberculosis Vaccine Initiative, Brewelskloof Hospital, Haarlem Street, Worcester, 6850, South Africa, Worcester, 6850, South Africa South African Tuberculosis Vaccine Initiative SATVI, Brewelskloof Hospital, Haarlem Street, Worcester, 6850, South Africa, Worcester, 6850, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/12/2020 Site name updated Family Centre for Research with Ubuntu, Tygerberg Childrens Hospital, Ward J8 Francie van Zijl Avenue Cape Town, 7505 South Africa, Cape Town, 7505, South Africa Family Centre for Research with Ubuntu FAMCRU, Tygerberg Childrens Hospital, Ward J8 Francie van Zijl Avenue Cape Town, 7505 South Africa, Cape Town, 7505, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/12/2020 Site name updated MeCRU clinical research Unit, Sefako Makgatho Health Science University Medunsa 0204 South Africa, Pretoria, 0204, South Africa MeCRU Clinical Research Unit, Sefako Makgatho Health Science University Medunsa 0204 South Africa, Pretoria, 0204, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 18/10/2021 Details updated MeCRU Clinical Research Unit, Sefako Makgatho Health Science University Medunsa 0204 South Africa, Pretoria, 0204, South Africa Mecru Clinical Research Unit MeCRU, Sefako Makgatho Health Science University Medunsa 0204 South Africa, Medunsa, 0204, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/12/2020 Site name updated Centre de Recherches Medicales de Lambarene, CERMEL, BP 242, Lambarene, Gabon, Lambarene, , Gabon Centre de Recherches Medicales de Lambarene CERMEL, CERMEL, BP 242, Lambarene, Gabon, Lambarene, , Gabon
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/12/2020 Site name updated KEMRI CRDR, At Siaya Country Referrall Hospital P.O. Box 144, Siaya, Kenya, Siaya, , Kenya Kenya Medical Research Institute Center for Respiratory Disease Research KEMRI CRDR, At Siaya Country Referrall Hospital P.O. Box 144, Siaya, Kenya, Siaya, , Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/12/2020 address updated Kenya Medical Research Institute Center for Respiratory Disease Research KEMRI CRDR, At Siaya Country Referrall Hospital P.O. Box 144, Siaya, Kenya, Siaya, , Kenya Kenya Medical Research Institute Center for Respiratory Disease Research KEMRI CRDR, KEMRI/CRDR At Siaya Country Referrall Hospital P.O. Box 144, Siaya, Kenya, Siaya, , Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/12/2020 Postal code updated Kenya Medical Research Institute Center for Respiratory Disease Research KEMRI CRDR, KEMRI/CRDR At Siaya Country Referrall Hospital P.O. Box 144, Siaya, Kenya, Siaya, , Kenya Kenya Medical Research Institute Center for Respiratory Disease Research KEMRI CRDR, KEMRI/CRDR At Siaya Country Referrall Hospital P.O. Box 144, Siaya, Kenya, Siaya, 144, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 18/10/2021 New site added Empilweni Services and Research Unit, Johannesburg, Coronation Ville, South Africa, 2093, Johannesburg, 2093, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 19/10/2021 Details updated Empilweni Services and Research Unit, Johannesburg, Coronation Ville, South Africa, 2093, Johannesburg, 2093, South Africa Empilweni Services and Research Unit ESRU, Johannesburg, Coronation Ville, South Africa, 2093, Johannesburg, 2093, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 19/10/2021 Details updated Empilweni Services and Research Unit ESRU, Johannesburg, Coronation Ville, South Africa, 2093, Johannesburg, 2093, South Africa Empilweni Services and Research Unit ESRU, Rahima Moosa Mother and Child Hospital, Cnr Oudtshoorn and Fuel Road, Coronationville, Johannesburg, 2093, South Africa, Johannesburg, 2093, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 18/10/2021 New site added NIMR Mbeya Medical Research Center, Hospital Hill Road, P.O.Box 2410, Mbeya - Tanzania, Mbeya, 2410, Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 19/10/2021 Details updated NIMR Mbeya Medical Research Center, Hospital Hill Road, P.O.Box 2410, Mbeya - Tanzania, Mbeya, 2410, Tanzania Mbeya Medical Research Center NIMR MMRC, Hospital Hill Road, P.O.Box 2410, Mbeya - Tanzania, Mbeya, 2410, Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/04/2020 There is no indication that other members of staff should also be listed. The staff members mentioned in the above comments were the staff members that completed the IRB/IEC application for each respective site. TRUE, Stellenbosch University Health Reaserch Ethics Commitee, Health Reaserch Ethics Commitee Stellenbosch University Private Bag X1, Matieland, 7602, Stellenbosch, Stellenbosch, 7602, South Africa, , 05 Mar 2020, +27219389702, afortuin@sun.ac.za, 9814_10105_4737.pdf TRUE, Stellenbosch University Health Reaserch Ethics Commitee, Health Reaserch Ethics Commitee Stellenbosch University Private Bag X1, Matieland, 7602, Stellenbosch, Stellenbosch, 7602, South Africa, , 05 Mar 2020, 0027219389702, afortuin@sun.ac.za, 9814_10105_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 29/04/2020 The documentation that SATVI received from UCT HREC is valid, completed and correct. The initial trial application was reviewed on 30 Aug 2020. SATVI addressed UCT HREC’s review comments in a letter dated 18 Feb 2020, where-after UCT HREC approval was granted on 10 Mar 2020. The site confirmed that the UCT approval letter is valid and a stamp is not a necessary requirement per the UCT HREC approval process and documentation. TRUE, University of Cape Town Human Reasarch Ethics Committee, Human Research Ethics Committee University of Cape Town Faculty of Health Sciences Room E53-46 Groote Schuur Hospital, OMB Observatory, 7925, Cape Town, 7925, South Africa, , 10 Mar 2020, +27214066338, hrec-enquiries@uct.ac.za, 9814_10115_4737.pdf TRUE, University of Cape Town Human Reasarch Ethics Committee, Human Research Ethics Committee University of Cape Town Faculty of Health Sciences Room E53-46 Groote Schuur Hospital, OMB Observatory, Cape Town, 7925, South Africa, , 10 Mar 2020, +27214066338, hrec-enquiries@uct.ac.za, 9814_10115_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 29/04/2020 There is no indication that other members of staff should also be listed. The staff members mentioned in the above comments were the staff members that completed the IRB/IEC application for each respective site. TRUE, Stellenbosch University Health Reaserch Ethics Commitee, Health Reaserch Ethics Commitee Stellenbosch University Private Bag X1, Matieland, 7602, Stellenbosch, Stellenbosch, 7602, South Africa, , 05 Mar 2020, 0027219389702, afortuin@sun.ac.za, 9814_10105_4737.pdf TRUE, Stellenbosch University Health Reaserch Ethics Commitee, Health Reaserch Ethics Commitee Stellenbosch University Private Bag X1, Matieland, Stellenbosch, Stellenbosch, 7602, South Africa, , 05 Mar 2020, 0027219389702, afortuin@sun.ac.za, 9814_10105_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 29/04/2020 There is no indication that other members of staff should also be listed. The staff members mentioned in the above comments were the staff members that completed the IRB/IEC application for each respective site. TRUE, Stellenbosch University Health Reaserch Ethics Commitee, Health Reaserch Ethics Commitee Stellenbosch University Private Bag X1, Matieland, Stellenbosch, Stellenbosch, 7602, South Africa, , 05 Mar 2020, 0027219389702, afortuin@sun.ac.za, 9814_10105_4737.pdf TRUE, Stellenbosch University Health Reaserch Ethics Commitee, Health Reaserch Ethics Commitee Stellenbosch University Private Bag X1, Matieland, Stellenbosch, Stellenbosch, 7602, South Africa, , 05 Mar 2020, +27219389702, afortuin@sun.ac.za, 9814_10105_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 29/04/2020 There is no indication that other members of staff should also be listed. The staff members mentioned in the above comments were the staff members that completed the IRB/IEC application for each respective site. E.g. Ms C Cockrell is the Ethics & Regulatory Administrator at RMPRU and she submitted the WITS HREC application on behalf of RMPRU. TRUE, University of Witwatersrand Human Research Ethics Committee WITS HREC, Suite 189, Private Bag x2600, Houghton 2041, South Africa, Houghton, 2041, South Africa, , 03 Oct 2019, +27117172301, Rhulani.Mkansi@wits.ac.za, 9814_10107_4737.pdf TRUE, University of Witwatersrand Human Research Ethics Committee WITS HREC, Suite 189, Private Bag x2600, Houghton, South Africa, Houghton, 2041, South Africa, , 03 Oct 2019, +27117172301, Rhulani.Mkansi@wits.ac.za, 9814_10107_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/10/2021 Date updated TRUE, Stellenbosch University Health Reaserch Ethics Commitee, Health Reaserch Ethics Commitee Stellenbosch University Private Bag X1, Matieland, Stellenbosch, Stellenbosch, 7602, South Africa, , 05 Mar 2020, +27219389702, afortuin@sun.ac.za, 9814_10105_4737.pdf TRUE, Stellenbosch University Health Reaserch Ethics Commitee, Health Reaserch Ethics Commitee Stellenbosch University Private Bag X1, Matieland, Stellenbosch, Stellenbosch, 7602, South Africa, , 25 Nov 2019, +27219389702, afortuin@sun.ac.za, 9814_10105_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/10/2021 Details updated TRUE, Stellenbosch University Health Reaserch Ethics Commitee, Health Reaserch Ethics Commitee Stellenbosch University Private Bag X1, Matieland, Stellenbosch, Stellenbosch, 7602, South Africa, , 25 Nov 2019, +27219389702, afortuin@sun.ac.za, 9814_10105_4737.pdf TRUE, Stellenbosch University Health Reaserch Ethics Commitee, Tygerberg Campus, Francie van Zyl Avenue, Tygerberg, 7505, South Africa, , 25 Nov 2019, +27219389702, afortuin@sun.ac.za, 9814_10105_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/04/2020 Name of Principal Investigator is updated in respective contact person section. TRUE, Sefako Makgatho University Research Ethics Committee, Sefako Makgatho University Research Ethics Committee, Prof GA Ogunbanjo SMUREC Chairperson PO BOX 63, MEDUNSA, 0204, South Africa, Pretoria North, 0204, South Africa, , 05 Sep 2019, +27824544523, lorato.phiri@smu.ac.za, 9814_10106_4737.pdf TRUE, Sefako Makgatho University Research Ethics Committee, Sefako Makgatho University Research Ethics Committee, Prof GA Ogunbanjo SMUREC Chairperson PO BOX 63, MEDUNSA, 0204, South Africa, Pretoria North, 0204, South Africa, , 05 Sep 2019, 0027824544523, lorato.phiri@smu.ac.za, 9814_10106_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 29/04/2020 There is no indication that other members of staff should also be listed. The staff members mentioned in the above comments were the staff members that completed the IRB/IEC application for each respective site. TRUE, Sefako Makgatho University Research Ethics Committee, Sefako Makgatho University Research Ethics Committee, Prof GA Ogunbanjo SMUREC Chairperson PO BOX 63, MEDUNSA, 0204, South Africa, Pretoria North, 0204, South Africa, , 05 Sep 2019, 0027824544523, lorato.phiri@smu.ac.za, 9814_10106_4737.pdf TRUE, Sefako Makgatho University Research Ethics Committee, Sefako Makgatho University Research Ethics Committee, Prof GA Ogunbanjo SMUREC Chairperson PO BOX 63, MEDUNSA, 0204, South Africa, Pretoria North, 0204, South Africa, , 05 Sep 2019, +27824544523, lorato.phiri@smu.ac.za, 9814_10106_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/10/2021 Details updated TRUE, Sefako Makgatho University Research Ethics Committee, Sefako Makgatho University Research Ethics Committee, Prof GA Ogunbanjo SMUREC Chairperson PO BOX 63, MEDUNSA, 0204, South Africa, Pretoria North, 0204, South Africa, , 05 Sep 2019, +27824544523, lorato.phiri@smu.ac.za, 9814_10106_4737.pdf TRUE, Sefako Makgatho University Research Ethics Committee, Molotlegi Street, Ga-Rankuwa, Medunsa, 0204, South Africa, , 06 Feb 2020, +27824544523, lorato.phiri@smu.ac.za, 9814_10106_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/04/2020 There is no indication that other members of staff should also be listed. The staff members mentioned in the above comments were the staff members that completed the IRB/IEC application for each respective site. TRUE, University of Witwatersrand Human Reasaech Ethics Committee WITS HREC, Suite 189, Private Bag x2600, Houghton 2041, South Africa, Houghton, 2041, South Africa, , 03 Oct 2019, +27117172301, Rhulani.Mkansi@wits.ac.za, 9814_10107_4737.pdf TRUE, University of Witwatersrand Human Reasaech Ethics Committee WITS HREC, Suite 189, Private Bag x2600, Houghton 2041, South Africa, Houghton, 2041, South Africa, , 03 Oct 2019, 0027117172301, Rhulani.Mkansi@wits.ac.za, 9814_10107_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 24/04/2020 Typographical error corrected TRUE, University of Witwatersrand Human Reasaech Ethics Committee WITS HREC, Suite 189, Private Bag x2600, Houghton 2041, South Africa, Houghton, 2041, South Africa, , 03 Oct 2019, 0027117172301, Rhulani.Mkansi@wits.ac.za, 9814_10107_4737.pdf TRUE, University of Witwatersrand Human Research Ethics Committee WITS HREC, Suite 189, Private Bag x2600, Houghton 2041, South Africa, Houghton, 2041, South Africa, , 03 Oct 2019, 0027117172301, Rhulani.Mkansi@wits.ac.za, 9814_10107_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 29/04/2020 The site confirmed that the WITS HREC approval letter is valid and a stamp is not a necessary requirement per the WITS HREC approval process and documentation. TRUE, University of Witwatersrand Human Research Ethics Committee WITS HREC, Suite 189, Private Bag x2600, Houghton 2041, South Africa, Houghton, 2041, South Africa, , 03 Oct 2019, 0027117172301, Rhulani.Mkansi@wits.ac.za, 9814_10107_4737.pdf TRUE, University of Witwatersrand Human Research Ethics Committee WITS HREC, Suite 189, Private Bag x2600, Houghton 2041, South Africa, Houghton, 2041, South Africa, , 03 Oct 2019, +27117172301, Rhulani.Mkansi@wits.ac.za, 9814_10107_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/12/2020 Ethics committee approval letter updated. TRUE, University of Witwatersrand Human Research Ethics Committee WITS HREC, Suite 189, Private Bag x2600, Houghton, South Africa, Houghton, 2041, South Africa, , 03 Oct 2019, +27117172301, Rhulani.Mkansi@wits.ac.za, 9814_10107_4737.pdf TRUE, University of Witwatersrand Human Research Ethics Committee WITS HREC, Suite 189, Private Bag x2600, Houghton, South Africa, Houghton, 2041, South Africa, , 24 Feb 2020, +27117172301, Rhulani.Mkansi@wits.ac.za, 9814_10107_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/10/2021 Details updated TRUE, University of Witwatersrand Human Research Ethics Committee WITS HREC, Suite 189, Private Bag x2600, Houghton, South Africa, Houghton, 2041, South Africa, , 24 Feb 2020, +27117172301, Rhulani.Mkansi@wits.ac.za, 9814_10107_4737.pdf TRUE, University of Witwatersrand Human Research Ethics Committee, Suite 189, Private Bag x2600, Houghton, South Africa, Houghton, 2041, South Africa, , 03 Oct 2019, +27117172301, Rhulani.Mkansi@wits.ac.za, 9814_10107_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 24/04/2020 Approval letter attached TRUE, University of Cape Town Human Reasarch Ethics Committee, Human Research Ethics Committee University of Cape Town Faculty of Health Sciences Room E53-46 Groote Schuur Hospital, OMB Observatory, 7925, Cape Town, 7925, South Africa, , 10 Mar 2020, +27214066338, hrec-enquiries@uct.ac.za, TRUE, University of Cape Town Human Reasarch Ethics Committee, Human Research Ethics Committee University of Cape Town Faculty of Health Sciences Room E53-46 Groote Schuur Hospital, OMB Observatory, 7925, Cape Town, 7925, South Africa, , 10 Mar 2020, +27214066338, hrec-enquiries@uct.ac.za, 9814_10115_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/10/2021 Details updated TRUE, University of Cape Town Human Reasarch Ethics Committee, Human Research Ethics Committee University of Cape Town Faculty of Health Sciences Room E53-46 Groote Schuur Hospital, OMB Observatory, Cape Town, 7925, South Africa, , 10 Mar 2020, +27214066338, hrec-enquiries@uct.ac.za, 9814_10115_4737.pdf TRUE, University of Cape Town Human Reasarch Ethics Committee, Floor E53, Room 46 Old Main Building Groote Schuur Hospital Observatory, Cape Town, 7925, South Africa, , 10 Mar 2020, +27214066338, hrec-enquiries@uct.ac.za, 9814_10115_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 16/12/2020 Ethics committee approval letter updated. FALSE, Comite d Ethique Institutionnel du CERMEL, CEI CERMEL BP 242 Lambarene BP1437 Libreville Gabon, Libreville, 1437, Gabon, 20 Sep 2019, , +2417791200, minsoko@yahoo.fr, TRUE, Comite d Ethique Institutionnel du CERMEL, CEI CERMEL BP 242 Lambarene BP1437 Libreville Gabon, Libreville, 1437, Gabon, 20 Sep 2019, 31 Jan 2020, +2417791200, minsoko@yahoo.fr, 9814_10118_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/10/2021 Details updated TRUE, Comite d Ethique Institutionnel du CERMEL, CEI CERMEL BP 242 Lambarene BP1437 Libreville Gabon, Libreville, 1437, Gabon, , 31 Jan 2020, +2417791200, minsoko@yahoo.fr, 9814_10118_4737.pdf TRUE, Comite d Ethique Institutionnel du CERMEL, BP 242 Lambarene BP1437 Libreville Gabon, Libreville, 1437, Gabon, , 31 Jan 2020, +2417791200, minsoko@yahoo.fr, 9814_10118_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 16/12/2020 Ethics committee approval letter updated. TRUE, Comite National d Ethique pour la Recherche, B.P. 2217 Libreville Gabon, Libreville, 2217, Gabon, , 11 Jan 2020, +2417878140, cnergabon@gmail.com, 9814_10119_4737.pdf TRUE, Comite National d Ethique pour la Recherche, B.P. 2217 Libreville Gabon, Libreville, 2217, Gabon, , 24 Jul 2020, +2417878140, cnergabon@gmail.com, 9814_10119_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/10/2021 Details updated TRUE, Comite National d Ethique pour la Recherche, B.P. 2217 Libreville Gabon, Libreville, 2217, Gabon, , 24 Jul 2020, +2417878140, cnergabon@gmail.com, 9814_10119_4737.pdf TRUE, Comite National d Ethique pour la Recherche, B.P. 2217 Libreville Gabon, Libreville, 2217, Gabon, , 11 Jan 2020, +2417878140, cnergabon@gmail.com, 9814_10119_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 29/04/2020 The site confirmed that the IHI-IRB approval letter is valid and a stamp is not a necessary requirement per the IHI-IRB approval process and documentation. TRUE, Ifakara Health Institute Institutional Review Board, The IHI IRB secretary Institutional Review Board P. O. BOX 78 373 Dar es Salaam, Tanzania, Dar es Salaam, 78373, Tanzania, , 12 Dec 2019, +255222774756, irb-submission@ihi.or.tz, 9814_10120_4737.pdf TRUE, Ifakara Health Institute Institutional Review Board IHI IRB, The IHI IRB secretary Institutional Review Board P. O. BOX 78 373 Dar es Salaam, Tanzania, Dar Es Salaam, 78373, Tanzania, , 12 Dec 2019, +255222774756, irb-submission@ihi.or.tz, 9814_10120_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 16/12/2020 Ethics committee approval letter updated. TRUE, Ifakara Health Institute Institutional Review Board IHI IRB, The IHI IRB secretary Institutional Review Board P. O. BOX 78 373 Dar es Salaam, Tanzania, Dar Es Salaam, 78373, Tanzania, , 12 Dec 2019, +255222774756, irb-submission@ihi.or.tz, 9814_10120_4737.pdf TRUE, Ifakara Health Institute Institutional Review Board IHI IRB, The IHI IRB secretary Institutional Review Board P. O. BOX 78 373 Dar es Salaam, Tanzania, Dar Es Salaam, 78373, Tanzania, , 14 Sep 2020, +255222774756, irb-submission@ihi.or.tz, 9814_10120_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/10/2021 Details updated TRUE, Ifakara Health Institute Institutional Review Board IHI IRB, The IHI IRB secretary Institutional Review Board P. O. BOX 78 373 Dar es Salaam, Tanzania, Dar Es Salaam, 78373, Tanzania, , 14 Sep 2020, +255222774756, irb-submission@ihi.or.tz, 9814_10120_4737.pdf TRUE, Ifakara Health Institute Institutional Review Board, The IHI IRB secretary Institutional Review Board P. O. BOX 78 373 Dar es Salaam, Tanzania, Dar Es Salaam, 78373, Tanzania, , 12 Dec 2019, +255222774756, irb-submission@ihi.or.tz, 9814_10120_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/10/2021 Details updated TRUE, Ifakara Health Institute Institutional Review Board, The IHI IRB secretary Institutional Review Board P. O. BOX 78 373 Dar es Salaam, Tanzania, Dar Es Salaam, 78373, Tanzania, , 12 Dec 2019, +255222774756, irb-submission@ihi.or.tz, 9814_10120_4737.pdf TRUE, Ifakara Health Institute Institutional Review Board, P. O. BOX 78 373 Dar es Salaam, Tanzania, Dar Es Salaam, 78373, Tanzania, , 12 Dec 2019, +255222774756, irb-submission@ihi.or.tz, 9814_10120_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 16/12/2020 Ethics committee approval letter updated. FALSE, National Health Research Ethics Review Committee, National Institute for Medical Research, 2448 Ocean Road, P. O. Box 9653, Dar Es Salaam Tanzania, Dar Es Salaam, 9653, Tanzania, 13 Dec 2019, , +255222121400, ethics@nimr.or.tz, TRUE, National Health Research Ethics Review Committee, National Institute for Medical Research, 2448 Ocean Road, P. O. Box 9653, Dar Es Salaam Tanzania, Dar Es Salaam, 9653, Tanzania, 13 Dec 2019, 30 Jun 2020, +255222121400, ethics@nimr.or.tz, 9814_10121_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/10/2021 Details updated TRUE, National Health Research Ethics Review Committee, National Institute for Medical Research, 2448 Ocean Road, P. O. Box 9653, Dar Es Salaam Tanzania, Dar Es Salaam, 9653, Tanzania, , 30 Jun 2020, +255222121400, ethics@nimr.or.tz, 9814_10121_4737.pdf TRUE, National Health Research Ethics Review Committee National Institute for Medical Research, 2448 Ocean Road, P. O. Box 9653, Dar Es Salaam Tanzania, Dar Es Salaam, 9653, Tanzania, , 30 Jun 2020, +255222121400, ethics@nimr.or.tz, 9814_10121_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 16/12/2020 Ethics Committee approval letter updated. FALSE, Kenya Medical Research Institute Scientific and Ethics Review Unit, P.O. BOX 54840 00200 OFF MBAGATHI ROAD, NAIROBI HOUSE NUMBER 8, KEMRI HEADQUARTERS, Nairobi, 54840, Kenya, 13 Dec 2019, , +254717719477, seru@kemri.org, TRUE, Kenya Medical Research Institute Scientific and Ethics Review Unit, P.O. BOX 54840 00200 OFF MBAGATHI ROAD, NAIROBI HOUSE NUMBER 8, KEMRI HEADQUARTERS, Nairobi, 54840, Kenya, 13 Dec 2019, 27 Aug 2020, +254717719477, seru@kemri.org, 9814_10123_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/10/2021 Details updated TRUE, Kenya Medical Research Institute Scientific and Ethics Review Unit, P.O. BOX 54840 00200 OFF MBAGATHI ROAD, NAIROBI HOUSE NUMBER 8, KEMRI HEADQUARTERS, Nairobi, 54840, Kenya, , 27 Aug 2020, +254717719477, seru@kemri.org, 9814_10123_4737.pdf TRUE, Kenya Medical Research Institute Scientific and Ethics Review Unit, P.O. BOX 54840 00200 OFF MBAGATHI ROAD, NAIROBI HOUSE NUMBER 8, KEMRI HEADQUARTERS, Nairobi, 54840, Kenya, , 01 Apr 2020, +254717719477, seru@kemri.org, 9814_10123_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/12/2020 Ethics Committee Approval letter updated. FALSE, Higher Degrees Research and Ethics Committee College of Health Sciences School of Public Health Makerere University, P.O.Box 7072, Kampala, Uganda, Kampala, 7072, Uganda, 27 Feb 2020, , +256414532207, hdrecadmin@musph.ac.ug, TRUE, Higher Degrees Research and Ethics Committee College of Health Sciences School of Public Health Makerere University, P.O.Box 7072, Kampala, Uganda, Kampala, 7072, Uganda, 27 Feb 2020, 30 Jul 2020, +256414532207, hdrecadmin@musph.ac.ug, 9814_10124_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/12/2020 Ethics Committee Approval letter updated. FALSE, Uganda National Council for Science and Technology, Plot 6 Kimera Rd P.O. BOX 6884 Kampala Uganda, Kampala, 6884, Uganda, 13 Dec 2019, , +256414705500, info@uncst.go.ug, TRUE, Uganda National Council for Science and Technology, Plot 6 Kimera Rd P.O. BOX 6884 Kampala Uganda, Kampala, 6884, Uganda, 13 Dec 2019, 14 Oct 2020, +256414705500, info@uncst.go.ug, 9814_10125_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/12/2020 Duplicate entry
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/10/2021 New site added TRUE, Mbeya Medical Research and Ethics Committee , Mbeya Zonal Referral Hospital Mbeya P.O. Box 419 Tanzania, Mbeya, 419, Tanzania, , 28 Jan 2021, +255252503456, info@mzrh.go.tz, 9814_15609_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 14/03/2025 Details of collaborator is updated to Serum Life Science Europe GmbH Vakzine Projekt Management GmbH, Mellendorfer Str. 9, D-30625 Hannover Germany, Hannover, 30625, Germany Serum Life Science Europe GmbH, Ahrensburger Strasse 1 30659 Hannover Germany, Hannover, 30659, Germany
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 22/12/2020 Name updated International AIDS Vaccine Initiative IAVI, Global Headquarters 125 Broad Street, 9th Floor New York, NY 10004 USA, New York, 10004, United States of America IAVI, Global Headquarters 125 Broad Street, 9th Floor New York, NY 10004 USA, New York, 10004, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 14/03/2025 Administrative change IAVI, Global Headquarters 125 Broad Street, 9th Floor New York, NY 10004 USA, New York, 10004, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 22/12/2020 Phone no. updated Principal Investigator, Mark Frederic, Cotton, Dr., mcot@sun.ac.za, , +27219384963, Tygerberg Childrens Hospital, Ward J8 Francie van Zijl Avenue Cape Town, 7505 South Africa, Cape Town, 7505, South Africa, Principal Investigator Principal Investigator, Mark Frederic, Cotton, Dr., mcot@sun.ac.za, , +27219384219, Tygerberg Childrens Hospital, Ward J8 Francie van Zijl Avenue Cape Town, 7505 South Africa, Cape Town, 7505, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 22/12/2020 Address updated Principal Investigator, Mark Frederic, Cotton, Dr., mcot@sun.ac.za, , +27219384219, Tygerberg Childrens Hospital, Ward J8 Francie van Zijl Avenue Cape Town, 7505 South Africa, Cape Town, 7505, South Africa, Principal Investigator Principal Investigator, Mark Frederic, Cotton, Dr., mcot@sun.ac.za, , +27219384219, Family Centre for Research with Ubuntu FAMCRU Tygerberg Childrens Hospital, Ward J8, Francie van Zijl Avenue, Cape Town, 7505, South Africa, Cape Town, 7505, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 14/03/2025 Name of Principal Investigator updated Principal Investigator, Mark Frederic, Cotton, Dr., mcot@sun.ac.za, , +27219384219, Family Centre for Research with Ubuntu FAMCRU Tygerberg Childrens Hospital, Ward J8, Francie van Zijl Avenue, Cape Town, 7505, South Africa, Cape Town, 7505, South Africa, Principal Investigator Principal Investigator, Shaun, Barnabas, Prof., barnabas@sun.ac.za, , +27219384219, Family Centre for Research with Ubuntu FAMCRU Tygerberg Childrens Hospital, Ward J8, Francie van Zijl Avenue, Cape Town, 7505, South Africa, Cape Town, 7505, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 22/12/2020 Phone no. updated Principal Investigator, Ayola Akim, Adegnika, Dr., aadegnika@gmail.com, , 0024107989191, CERMEL, BP 242, Lambarene, Gabon, Lambarene, , Gabon, Principal Investigator Principal Investigator, Ayola Akim, Adegnika, Dr., aadegnika@gmail.com, , +24107989191, CERMEL, BP 242, Lambarene, Gabon, Lambarene, , Gabon, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 18/10/2021 Details updated Principal Investigator, Ayola Akim, Adegnika, Dr., aadegnika@gmail.com, , +24107989191, CERMEL, BP 242, Lambarene, Gabon, Lambarene, , Gabon, Principal Investigator Principal Investigator, Ayola Akim, Adegnika, Dr., aadegnika@gmail.com, , +24107989191, Centre de Recherches Mdicales de Lambarn CERMEL, BP 242, Lambarene, Gabon, Lambarene, , Gabon, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 22/12/2020 Site address updated Principal Investigator, Francis, Mhimbira, Dr., fmhimbira@ihi.or.tz, , +255754291657, Mwanyamala District Hospital P.O. Box 61665 Kinondoni district, Dar es Salaam, Tanzania, Dar es Salaam, 61665, Tanzania, Principal Investigator Principal Investigator, Francis, Mhimbira, Dr., fmhimbira@ihi.or.tz, , +255754291657, Ifakara Health Institute IHI Mwanyamala District Hospital, P.O. Box 61665, Kinondoni district, Dar es Salaam, Tanzania, Dar es Salaam, 61665, Tanzania, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 18/10/2021 Details updated Principal Investigator, Videlis, Nduba, Dr., vnduba@gmail.com, , +254724522474, KEMRI CRDR Nairobi KNH Complex, Behind Government Chemist P.O. Box 47855-00100 Nairobi, Kenya, Nairobi, 47855, Kenya, Principal Investigator Principal Investigator, Videlis, Nduba, Dr., vnduba@gmail.com, , +254724522474, KEMRI CRDR Nairobi KNH Complex Behind Government Chemist, P.O. Box 47855-00100, Nairobi, Kenya and KEMRI/CRDR Siaya at Siaya Country Referral Hospital, P.O. Box 144, Siayu, Kenya, Nairobi, 47855, Kenya, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/04/2020 Added principal investigator for the site in South Africa. Principal Investigator, Matsontso, Mathebula, Dr., matsontso.mathebula@smu.ac.za, , 00270125215714, Sefako Makgatho Health Science, University, MECRU Clinical Research Unit, Medusa, Medusa, 0204, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/04/2020 Principal Investigator details updated Principal Investigator, Matsontso, Mathebula, Dr., matsontso.mathebula@smu.ac.za, , 00270125215714, Sefako Makgatho Health Science, University, MECRU Clinical Research Unit, Medusa, Medusa, 0204, South Africa, Principal Investigator Principal Investigator, Matsontso, Mathebula, Dr., matsontso.mathebula@smu.ac.za, , 00270125215714, Medunsa Clinical Research Unit, Sefako Makgatho Health Science, University, MECRU Clinical Research Unit, Medusa, Medusa, 0204, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 18/10/2021 Details updated Principal Investigator, Matsontso, Mathebula, Dr., matsontso.mathebula@smu.ac.za, , 00270125215714, Medunsa Clinical Research Unit, Sefako Makgatho Health Science, University, MECRU Clinical Research Unit, Medusa, Medusa, 0204, South Africa, Principal Investigator Principal Investigator, Matsontso, Mathebula, Dr., matsontso.mathebula@smu.ac.za, , 00270125215714, Mecru Clinical Research Unit MeCRU, Sefaka Makgatho Health Science University, Medunsa, 0204, South Africa, Medunsa, 0204, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/04/2020 Principal investigator details are updated. Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , 0027113866137, 11th floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Diepkloof, Soweto, Soweto, , South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/04/2020 Principal investigators details updated Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , 0027113866137, 11th floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Diepkloof, Soweto, Soweto, , South Africa, Principal Investigator Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , 0027113866137, 11th floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Diepkloof, Soweto, PO Bertsham, 2013, Soweto, 2013, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/04/2020 Principal Investigator details updated Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , 0027113866137, 11th floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Diepkloof, Soweto, PO Bertsham, 2013, Soweto, 2013, South Africa, Principal Investigator Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , 0027113866137, Respiratory and Meningeal Pathogens Research Unit, 11th floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Diepkloof, Soweto, PO Bertsham, 2013, Soweto, 2013, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 22/12/2020 Contact no. updated Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , 0027113866137, Respiratory and Meningeal Pathogens Research Unit, 11th floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Diepkloof, Soweto, PO Bertsham, 2013, Soweto, 2013, South Africa, Principal Investigator Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , +27119834283, Respiratory and Meningeal Pathogens Research Unit, 11th floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Diepkloof, Soweto, PO Bertsham, 2013, Soweto, 2013, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 22/12/2020 Address updated Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , +27119834283, Respiratory and Meningeal Pathogens Research Unit, 11th floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Diepkloof, Soweto, PO Bertsham, 2013, Soweto, 2013, South Africa, Principal Investigator Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , +27119834283, Respiratory and Meningeal Pathogens Research Unit RMPRU, 1st floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Soweto PO Bertsham, 2013, South Africa, Soweto, 2013, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 14/03/2025 Principal Investigator details updated Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , +27119834283, Respiratory and Meningeal Pathogens Research Unit RMPRU, 1st floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Soweto PO Bertsham, 2013, South Africa, Soweto, 2013, South Africa, Principal Investigator Principal Investigator, Megan Jane, Dempster, Dr., megan.dempster@wits-vida.org, , +27836472827, Respiratory and Meningeal Pathogens Research Unit RMPRU, 1st floor, Central-West wing, Nurses residence, Chris Hani Baragwanath Hospital, Chris Hani Road, Soweto PO Bertsham, 2013, South Africa, Soweto, 2013, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/04/2020 Principal Investigator details updated Principal Investigator, Mark, Hatherill, Prof., mark.hatherill@uct.ac.za, , 00270214066145, South African Tuberculosis Vaccine Initiative-SATVI, Brewellskloof Hospital, Haarlem St, Van Riebeeck Park, Worcester, 6850, Worcester, 6859, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/04/2020 Principal Investigator details updated Principal Investigator, Mark, Hatherill, Prof., mark.hatherill@uct.ac.za, , 00270214066145, South African Tuberculosis Vaccine Initiative-SATVI, Brewellskloof Hospital, Haarlem St, Van Riebeeck Park, Worcester, 6850, Worcester, 6859, South Africa, Principal Investigator Principal Investigator, Mark, Hatherill, Prof., mark.hatherill@uct.ac.za, , 00270214066145, South African Tuberculosis Vaccine Initiative-SATVI, Brewellskloof Hospital, Haarlem St, Van Riebeeck Park, Worcester, 6850, Worcester, 6850, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 22/12/2020 Site details updated. Principal Investigator, Mark, Hatherill, Prof., mark.hatherill@uct.ac.za, , 00270214066145, South African Tuberculosis Vaccine Initiative-SATVI, Brewellskloof Hospital, Haarlem St, Van Riebeeck Park, Worcester, 6850, Worcester, 6850, South Africa, Principal Investigator Principal Investigator, Angelique, Kany Kany Luabeya, Prof., angelique.luabeya@uct.ac.za, , +27233465400, South African Tuberculosis Vaccine Initiative SATVI Brewelskloof Hospital, Haarlem Street, Worcester, 6850, South Africa, Worcester, 6850, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/04/2020 Principal Investigator details updated Principal Investigator, Anne, Wajja, Dr., anne.wajja@mrcuganda.org, , 00256778103960, Plot 51-59, Nakiwogo Road, Entebbe, Uganda, Entebbe, , Uganda, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/10/2021 New Site added Principal Investigator, Issa, Sabi, Dr., isabi@nimr-mmrc.org, isabimd@yahoo.com, +255252503364, NIMR-Mbeya Medical Research Center Hospital Hill Road, P.O.Box 2410, Mbeya - Tanzania, Mbeya, 2410, Tanzania, Head Department of Tuberculosis and Emerging Diseases NIMR Mbeya Medical Research Center
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/10/2021 Details updated Principal Investigator, Issa, Sabi, Dr., isabi@nimr-mmrc.org, isabimd@yahoo.com, +255252503364, NIMR-Mbeya Medical Research Center Hospital Hill Road, P.O.Box 2410, Mbeya - Tanzania, Mbeya, 2410, Tanzania, Head Department of Tuberculosis and Emerging Diseases NIMR Mbeya Medical Research Center Principal Investigator, Issa, Sabi, Dr., isabi@nimr-mmrc.org, isabimd@yahoo.com, +255252503364, NIMR-Mbeya Medical Research Center Hospital Hill Road, P.O.Box 2410, Mbeya - Tanzania, Mbeya, 2410, Tanzania, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/10/2021 New Site added Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , +27119834283, Johannesburg, Coronation Ville, South Africa,2093, Johannesburg, 2093, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/10/2021 Details updated Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , +27119834283, Johannesburg, Coronation Ville, South Africa,2093, Johannesburg, 2093, South Africa, Principal Investigator Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , +27119834283, Rahima Moosa Mother and Child Hospital ESRU Cnr Oudtshoorn and Fuel Road, Coronationville, Johannesburg, 2093, South Africa, Johannesburg, 2093, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 14/03/2025 Details of Principal Investigators updated Principal Investigator, Shabir, Madhi, Prof., madhis@rmpru.co.za, , +27119834283, Rahima Moosa Mother and Child Hospital ESRU Cnr Oudtshoorn and Fuel Road, Coronationville, Johannesburg, 2093, South Africa, Johannesburg, 2093, South Africa, Principal Investigator Principal Investigator, Megan Jane, Dempster, Dr., megan.dempster@wits-vida.org, , +27836472827, Rahima Moosa Mother and Child Hospital ESRU Cnr Oudtshoorn and Fuel Road, Coronationville, Johannesburg, 2093, South Africa, Johannesburg, 2093, South Africa, Principal Investigator
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 14/04/2020 The Individual Participant Data (IPD) will be shared after study completion. Undecided Yes
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Reporting IPD description 14/04/2020 The Individual Participant Data (IPD) will be shared after study completion. Individual Participant Data (IPD) listing including demographic data, safety data listing will be shared.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 14/04/2020 The Individual Participant Data (IPD) will be shared after study completion. Within 2 years of study completion
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Reporting Key access criteria 14/04/2020 The Individual Participant Data (IPD) will be shared after study completion. IPD will be sared based on controlled access data type.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 14/04/2020 The Individual Participant Data (IPD) will be shared after study completion. Clinical Study Report