Clinical trial: PsA-TT-007

Results from PsA-TT-007 will help identify optimal strategies for the protection of new birth cohorts.

This Phase 3 clinical trial in Mali sought to determine the optimal schedule and formulation of the meningococcal A conjugate (PsA-TT) vaccine for routine immunization before two years of age, in coadministration with Expanded Programme on Immunization (EPI) vaccines. The study also assessed the safety of the vaccine. A total of 1,500 subjects were enrolled.

Study title: A Phase 3, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of different schedules and formulations of a meningococcal A conjugate vaccine administered concomitantly with local EPI vaccines in healthy infants and toddlers

Primary end point: Immunogenicity

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: 1,500 subjects, aged between 9 and 12 months at time of enrollment

Start date: 6 March 2012

End date: Closeout visit held in December 2013

Status: Completed

International registration number: PACTR201110000328305

Photo: Monique Berlier/PATH.