Clinical trial: PsA-TT-003a

community meeting

Community information session before the start of clinical trial psA-TT-003a.

This Phase 2/3 clinical trial was held in India and compared the immunogenicity and long-term persistence of antibodies of a single dose of the meningococcal A conjugate (PsA-TT) vaccine with that of the meningococcal A component of the polysaccharide ACWY vaccine. The study also assessed the safety of the vaccine. A total of 345 subjects were enrolled.

Study title: A Phase II/III, observer-blind, randomized, active controlled study to compare the safety and immunogenicity of a meningococcal A conjugate vaccine (PsA-TT) with meningococcal ACWY polysaccharide vaccine administered in healthy children 2–10 years of age.

Study title: A Phase II/III, observer-blind, randomized, active controlled study to compare the safety and immunogenicity of a meningococcal A conjugate vaccine (PsA-TT) with meningococcal ACWY polysaccharide vaccine administered in healthy subjects 2 to 29 years of age.

Primary end point: Immunogenicity

Secondary end point: Safety

Study results: Results show that the vaccine is safe and highly immunogenic.

Vaccine manufacturer: Serum Institute of India, Ltd.

Development stage: Phase 2/3

Countries: India

Clinical sites: Shirdi Sai Baba Hospital, Pune, India

Principal investigators: Siddhivinayak Hirve, MD

Number of subjects: 345 subjects, aged between 2 and 10 years

Start date: 29 August 2007

Date of last subject last visit: 27 November 2008

Status: Completed

International Standard Randomized Controlled Trial Number: ISRCTN46335400

Publication(s)

Hirve S, Bavdekar A, Pandit A, et al. Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2-10 years: a phase II/III double-blind randomized controlled trial. Vaccine. 2012;30(45):6456–6460.

Selected poster(s) and abstract(s)

Hirve S, Bavdekar A, Pandit A, et al. Safety and immunogenicity of a new meningococcal A conjugate vaccine in healthy Indian children aged 2–10 years (pdf 1.49 mb). Presented at: 16th International Pathogenic Neisseria Conference, 7–12 September 2008; Rotterdam, the Netherlands. P227 (pdf 4.21 mb). (pdf 4.21 mb).

Photo: Monique Berlier.