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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Methodology and lessons-learned from the efficacy clinical trial of the pentavalent rotavirus vaccine in Bangladesh
Vaccine, Volume 30, No. SUPPL. 1, Year 2012
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Description
An efficacy clinical trial with pentavalent rotavirus vaccine (PRV), RotaTeq®, was conducted at Matlab field site of ICDDR,B, Bangladesh from March 2007 to March 2009. The methodology, including operation logistics, and lessons-learned are described in this report. Vaccination was organized at 41 fixed-site clinics twice/month. A total of 1136 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age with routine vaccines of the Expanded Programme on Immunization (EPI) schedule. Twelve field-workers routinely visited study participants for safety and efficacy follow-up. The study was conducted following good clinical practices and maintaining cold-chain requirements. There were no temperature deviations of clinical vaccine supplies. Data entry was done using the source documents to a central database developed by the sponsor which was linked to web. Among enrolled infants, 1128 (99.3%) received 3 doses of PRV/placebo and efficacy follow-up was conducted for a median of 554 days. For the evaluation of immunogenicity, blood samples were collected from 150 participants predose 1 and from 147 (98%) of the same participants post dose 3. Stool samples were collected from 778 (99.9%) acute gastroenteritis episodes among children who reported to diarrhoea treatment centres. Thirty-nine serious adverse events, including 6 deaths, occurred among study participants. The efficacy of PRV against severe rotavirus gastroenteritis was 42.7% through the entire follow-up period; serum anti-rotavirus IgA response was 78.1%. Inclement weather, difficult transportation, and movement of study participants were some of the challenges identified. This is the first vaccine trial in rural Bangladesh with online data entry. The study was well accepted in the community and was completed successfully. © 2011 Elsevier Ltd.
Authors & Co-Authors
Zaman, Khalequzzaman S.
Bangladesh, Dhaka
International Centre for Diarrhoeal Disease Research Bangladesh
Yunus, Mohammad Faisal Mohammed
Bangladesh, Dhaka
International Centre for Diarrhoeal Disease Research Bangladesh
Arifeen, Shams E.
Bangladesh, Dhaka
International Centre for Diarrhoeal Disease Research Bangladesh
Azim, Tasnim
Bangladesh, Dhaka
International Centre for Diarrhoeal Disease Research Bangladesh
Faruque, Abu Syed Golam
Bangladesh, Dhaka
International Centre for Diarrhoeal Disease Research Bangladesh
Hossain, Ilias M.
Bangladesh, Dhaka
International Centre for Diarrhoeal Disease Research Bangladesh
Luby, Stephen P.
Bangladesh, Dhaka
International Centre for Diarrhoeal Disease Research Bangladesh
Victor, John C.
United States, Seattle
Path Seattle
Dallas, Michael J.
United States, Rahway
Merck & Co., Inc.
Lewis, Kristen D.C.
United States, Seattle
Path Seattle
Rivers, Stephen B.
United States, Rahway
Merck & Co., Inc.
Steele, Andrew Duncan
United States, Seattle
Path Seattle
Neuzil, Kathleen Maletic
United States, Seattle
Path Seattle
Ciarlet, Max
United States, Rahway
Merck & Co., Inc.
United States, Cambridge
Novartis Vaccines and Diagnostics, Inc.
Sack, David Allen
United States, Baltimore
Johns Hopkins Bloomberg School of Public Health
Statistics
Citations: 22
Authors: 15
Affiliations: 5
Identifiers
Doi:
10.1016/j.vaccine.2011.07.117
ISSN:
18732518
Research Areas
Infectious Diseases
Maternal And Child Health
Study Design
Cohort Study