Clinical trial: PsA-TT-004
Field researcher carrying clinical report forms the local way, Navrongo, Ghana.
This Phase 2 clinical trial in Ghana evaluated the immunogenicity, dose response, and schedule response of the meningococcal A conjugate (PsA-TT) vaccine administered concomitantly with local Expanded Programme on Immunization (EPI) vaccines in healthy infants. The study also assessed the safety of the vaccine. A total of 1,200 subjects were enrolled.
Study title: A Phase II, double-blind, randomized, controlled, dose-ranging study to evaluate the safety, immunogenicity, dose response, and schedule response of a meningococcal A conjugate vaccine administered concomitantly with local EPI vaccines in healthy infants.
Primary end point: Immunogenicity
Secondary end point: Safety
Study results: Preliminary results show that the vaccine is safe and highly immunogenic. Final results will be presented in a forthcoming scientific publication.
Vaccine manufacturer: Serum Institute of India, Ltd.
Development stage: Phase 2
Clinical site: Navrongo Health Research Center, Navrongo, Ghana
Principal investigator: Abraham Hodgson, MD, PhD
Number of subjects: 1,200 subjects, aged between 14 and 18 weeks at the time of first enrollment.
Start date: 27 November 2008
End date: Closeout visit held in November 2012
International Standard Randomized Controlled Trial Number: ISRCTN82484612
Marchetti E, Mazarin-Diop V, Chaumont J, et al. Conducting vaccine clinical trials in sub-Saharan Africa: operational challenges and lessons learned from the Meningitis Vaccine Project. Vaccine. 2012;30(48):6859–6863.
Photo: Julie Chaumont.