Clinical trial: PsA-TT-006

Health workers.

Local monitor Rokiatou Dembele shows a sample trial identification card to potential participants.

This Phase 3 clinical trial in Mali evaluated the safety of a single dose of the meningococcal A conjugate (PsA-TT) vaccine. The study also compared the safety profile of the PsA-TT vaccine with that of a licensed polysaccharide ACWY vaccine. A total of 6,000 participants will be enrolled.

Study title: A Phase III, observer-blind, randomized, active controlled study to evaluate the safety of one dose of a meningococcal A conjugate vaccine administered to healthy subjects 1 to 29 years of age, Bamako, Mali

Primary end point: Safety

Secondary end point: Safety

Study results: No preliminary results are available.

Vaccine manufacturer: Serum Institute of India, Ltd.

Development stage: Phase 3

Country: Mali

Clinical site: Center for Vaccine Development-Mali (CVD-Mali), Bamako, Mali

Principal investigators: Samba Sow, MD

Number of subjects: 6,000 subjects, aged between 1 and 29 years

Start date: 22 February 2010

Date of last subject last visit: 7 January 2011

Status: Completed

International registration number: PACTR ATMR2010030001913177


Photo: Monique Berlier.