Changes to trial information |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Actual trial start date |
07/08/2023 |
Update |
|
04 May 2022 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Completion date |
07/08/2023 |
Update |
|
05 Jul 2023 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Completion date |
07/08/2023 |
Update |
05 Jul 2023 |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Completion date |
07/02/2024 |
Information received from Sponsor |
|
22 Dec 2023 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Final no of participants |
07/08/2023 |
Update |
|
3219 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
01/06/2022 |
IRESSEF site in Senegal started recruitment on 04-May-2022. Screening started on 04-May-2022 and first enrolment was on 10-May-2022.
|
Not yet recruiting |
Recruiting |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
08/08/2023 |
Update |
Recruiting |
Closed to recruitment,follow-up continuing |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
06/02/2024 |
LPLV occurred on 22-Dec-2023 |
Closed to recruitment,follow-up continuing |
Completed |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
16/09/2022 |
Nairobi postal code added. SERU Approval letter received |
FALSE, KEMRI IRB Kenya Medical Research Institute Scientific and Ethics Review Unit KEMRI SERU, PO Box 54840 00200 off Mbagathi Road, Nairobi, None, Kenya, 09 Jul 2021, , +254722205901, seru@kemri.org, |
TRUE, KEMRI IRB Kenya Medical Research Institute Scientific and Ethics Review Unit KEMRI SERU, PO Box 54840 00200 off Mbagathi Road, Nairobi, 00100, Kenya, 09 Jul 2021, 01 Sep 2022, +254722205901, seru@kemri.org, 16067_13474_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
16/09/2022 |
Approval letter received |
FALSE, WRAIR Walter Reed Army Institute of Research , 503 Robert Grant Avenue, Silver Spring , MD 20910, United States of America, 14 Sep 2021, , +13013199000, usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil, |
TRUE, WRAIR Walter Reed Army Institute of Research , 503 Robert Grant Avenue, Silver Spring , MD 20910, United States of America, 14 Sep 2021, 01 Jun 2022, +13013199000, usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil, 16067_13475_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
22/12/2021 |
Updated |
FALSE, CNERS Comite National dEthique pour Ia Recherche en Sante , Ministere de la Sante et de lAction Sociale, Aime Cesaire, Fann Residence, Dakar, None, Senegal, 10 Aug 2021, , +221773614212, ousmanediouf7@gmail.com, |
TRUE, CNERS Comite National dEthique pour Ia Recherche en Sante , Ministere de la Sante et de lAction Sociale, Aime Cesaire, Fann Residence, Dakar, None, Senegal, 10 Aug 2021, 07 Dec 2021, +221773614212, ousmanediouf7@gmail.com, 16067_13477_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
22/12/2021 |
post code included |
TRUE, CNERS Comite National dEthique pour Ia Recherche en Sante , Ministere de la Sante et de lAction Sociale, Aime Cesaire, Fann Residence, Dakar, None, Senegal, , 07 Dec 2021, +221773614212, ousmanediouf7@gmail.com, 16067_13477_4737.pdf |
TRUE, CNERS Comite National dEthique pour Ia Recherche en Sante , Ministere de la Sante et de lAction Sociale, Aime Cesaire, Fann Residence, Dakar, 12500, Senegal, , 07 Dec 2021, +221773614212, ousmanediouf7@gmail.com, 16067_13477_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
16/09/2022 |
Approval letter received from WCG IRB (tracing its roots to the founding of Western Institutional Review Board (WIRB) and integration of WIRB with four leading independent IRBs in 2020 — Copernicus Group IRB, New England IRB, Aspire IRB, and Midlands IRB |
|
TRUE, WCG Institutional Review Board IRB, 1019 39th Ave., SE, Suite 120, Puyallup, WA 98374, United States of America, , 29 Jun 2022, +18558182289, clientcare@wcgirb.com, 16067_18658_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
16/09/2022 |
Research License received - Ref 175060 |
|
TRUE, National Commission for Science Technology and Innovation NACOSTI, off Waiyaki Way, Upper Kabete, Nairobi, 00100, Kenya, , 03 Aug 2022, +25204007000, dg@nacosti.go.ke, 16067_18659_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
16/09/2022 |
Regulatory Authority / MOH approval |
|
TRUE, Pharmacy and Poisons Board MOH, Pharmacy and Poisons Board Hourse, Lenana Road , Nairobi, 00100, Kenya, , 01 Sep 2022, +25202716905, info@pharmacyboardkenya.org, 16067_18660_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Funding Source |
FundingSources List |
17/12/2024 |
RIGHT Foundation is the only funding source. |
Research Investment for Global Health Technology RIGHT Fund and TBD, International Vaccine Institute, 2nd Floor, SNU, Research Park, 1 Gwanak-ro, Gwanak-gu, Seoul, 08826, Korea, Republic of, Funding Agency, |
Research Investment for Global Health Technology RIGHT Fund , International Vaccine Institute, 2nd Floor, SNU, Research Park, 1 Gwanak-ro, Gwanak-gu, Seoul, 08826, Korea, Republic of, Funding Agency, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Funding Source |
FundingSources List |
05/01/2022 |
Updated |
EuBiologics Co. Ltd, 125, Wonmudong-gil, Dongsan-myeon, Chuncheon-si, Gangwon-do, Chuncheon si, , China, Commercial Sector / Industry, |
EuBiologics Co. Ltd, 8F Seongdo B/D, 207 Dosan-daero, Sinsa-dong ,Gangnam-gu, Seoul, 06026, Korea, Republic of, Commercial Sector / Industry, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Funding Source |
FundingSources List |
17/12/2024 |
Updated |
EuBiologics Co. Ltd, 8F Seongdo B/D, 207 Dosan-daero, Sinsa-dong ,Gangnam-gu, Seoul, 06026, Korea, Republic of, Commercial Sector / Industry, |
EuBiologics Co. Ltd, 13F,15F, 509, Dosan-daero, Gangnam-gu, Seoul, 06026, Korea, Republic of, Commercial Sector / Industry, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Funding Source |
FundingSources List |
17/12/2024 |
Updated |
EuBiologics Co. Ltd, 13F,15F, 509, Dosan-daero, Gangnam-gu, Seoul, 06026, Korea, Republic of, Commercial Sector / Industry, |
EuBiologics Co. Ltd, 13F,15F, 509, Dosan-daero, Gangnam-gu, Seoul, 06012, Korea, Republic of, Commercial Sector / Industry, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Sponsors |
Sponsors List |
05/01/2022 |
Update |
EuBiologics Co Ltd, R D Center 125 Wonmudong gil Dongsan myeon Chuncheon si Gangwon do Korea, Chuncheon si, , China, Primary Sponsor, Commercial Sector/Industry, |
EuBiologics Co Ltd, 8F Seongdo B/D, 207 Dosan-daero, Sinsa-dong ,Gangnam-gu, Seoul, 06026, Korea, Republic of, Primary Sponsor, Commercial Sector/Industry, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Contact People |
Contacs List |
17/12/2024 |
Update contact people |
|
Public Enquiries, Howard , Her, Mr., hher@EuBiologics.com, , +8225726675, EuBiologics, Co., Ltd, 13F,15F, 509, Dosan-daero, Gangnam-gu, Seoul, 06012, Korea, Democratic People's Republic of, Sponsor |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Contact People |
Contacs List |
05/01/2022 |
Medical Officer needed to be updated from Rashan Ederm to Patricia Njuguna. |
Scientific Enquiries, Rahsan, Erdem, Dr., rerdem@path.org, , +12025404546, PATH Center for Vaccine Innovation and Access, CVIA, 455 Massachusetts Avenue, Suite 1000 Washington, DC 20001 USA, Washington DC, 20001, United States of America, PATH Medical Officer |
Scientific Enquiries, Patricia , Njuguna, Dr., pnjuguna@path.org, , +254721833063, PATH Center for Vaccine Innovation and Access, CVIA, ACS Plaza, 4th floor, Lenana Road, Nairobi, , Kenya, PATH Medical Officer |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Contact People |
Contacs List |
16/09/2022 |
postal code for Nairobi added |
Scientific Enquiries, Patricia , Njuguna, Dr., pnjuguna@path.org, , +254721833063, PATH Center for Vaccine Innovation and Access, CVIA, ACS Plaza, 4th floor, Lenana Road, Nairobi, , Kenya, PATH Medical Officer |
Scientific Enquiries, Patricia , Njuguna, Dr., pnjuguna@path.org, , +254721833063, PATH Center for Vaccine Innovation and Access, CVIA, ACS Plaza, 4th floor, Lenana Road, Nairobi, 00100, Kenya, PATH Medical Officer |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Contact People |
Contacs List |
16/09/2022 |
Telephone number updated |
Scientific Enquiries, Patricia , Njuguna, Dr., pnjuguna@path.org, , +254721833063, PATH Center for Vaccine Innovation and Access, CVIA, ACS Plaza, 4th floor, Lenana Road, Nairobi, 00100, Kenya, PATH Medical Officer |
Scientific Enquiries, Patricia , Njuguna, Dr., pnjuguna@path.org, , +254101833063, PATH Center for Vaccine Innovation and Access, CVIA, ACS Plaza, 4th floor, Lenana Road, Nairobi, 00100, Kenya, PATH Medical Officer |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD description |
17/12/2024 |
Updated IPD Description |
The results of the trial will be shared with trial participants in a manner clearly stipulated by the protocol team. The Study Report will also be made available in line with the country, international and sponsor regulations.
|
Data obtained through this study may be provided to qualified researchers with academic interest in Meningococcal disease. The individual participant data (IPD) that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD-Sharing time frame |
17/12/2024 |
Updated IPD-Sharing Time Frame |
Three (3) years |
Beginning 3 months and ending 3 years following article publication. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Key access criteria |
17/12/2024 |
Updated Key Access Criteria |
Final Study Report from protocol team
|
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact EuBiologics, info@eubiologics.com.
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Study protocol document |
17/12/2024 |
Updated Additional Document Type |
Clinical Study Report |
Study Protocol |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Results Available |
17/12/2024 |
Results available |
No |
Yes |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Result Summary Pdf file1 |
17/12/2024 |
Summary of results uploaded |
|
16067_11145_1045.pdf |