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

Countries: Ghana

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

Status: Completed

International Standard Randomized Controlled Trial Number: ISRCTN82484612

Publication(s)

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.