Meningitis Vaccine Project, MVP 005

Title: A phase III, double-blind, randomized, active controlled study to evaluate the safety and consistency of immunogenicity of three consecutive lots of a Meningococcal A Conjugate Vaccine administered as a single dose to healthy children at 5-10 years of age Period: January 2010 to December 2010

Collaborators: WHO, PATH Sponsor: SIIL

Investigator/s: Dr. Siddhivinayak Hirve, Dr. Anand Pandit, Dr. Ashish Bavdekar.

Rationale: It is a lot-to-lot consistency study, intended to evaluate the safety and immunogenicity of a single dose of three consecutively produced lots of 10 µg of PsA-TT vaccine in chidren 5 to 10 years of age. These three lots are representative of the formulation intended for licensure.

Aims and objectives: Primary objective: To demonstrate the consistency of the immunogenicity at 28 days after a single dose of three consecutive lots of the PsA-TT vaccine given to children at 5 to 10 years of age. Secondary objectives: Safety:

  • To evaluate the safety of a single dose of three consecutive lots of the PsA-TT vaccine and of the Meningococcal Polysaccharide Vaccine A+C (PsAC) when administered to healthy children at 5 to 10 years of age, 28 days and 56 days (two months) after vaccination.

Immunogenicity:

  • To evaluate the immunogenicity at 28 days after a single dose of PsAC vaccine in children 5 to 10 years of age.

Study Design: Phase III, double blind, randomized, comparative clinical study Study population/ Sample size: 830 healthy indian children of 5 to 10 years of age

Endpoints: Primary endpoint The percentage of subjects who show a seroconversion for anti-Meningococcal Polysaccharide A (MenPsA) antibodies, i.e. a 4-fold increase in post-immunization serum titer with respect to pre-immunization serum titer, at 28 days after a single vaccine dose, as measured by rSBA assay.

Feedback/Dissemination of results (in addition to publication), if any: The study Results were presented in MVP dissemination meeting held at KEM Hospital Research Centre, Pune from 21-22 Feb 2011. The results were also shared with community by conducting meetings at village level.

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