Changes to trial information |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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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
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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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
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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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
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Field Name
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Date
|
Reason
|
Old Value
|
Updated Value
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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
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Field Name
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Date
|
Reason
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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
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Field Name
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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
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Field Name
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Date
|
Reason
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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
|
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 |
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 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
|
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 |
Final no of participants |
07/08/2023 |
Update |
|
3219 |
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 |
Recruitment status |
08/08/2023 |
Update |
Recruiting |
Closed to recruitment,follow-up continuing |