Summary
of Study:
MVP, a partnership between WHO and PATH, was created
in 2001 through core funding from the Bill & Melinda
Gates Foundation with the goal of eliminating meningococcal
epidemics in sub-Saharan Africa through the development
and use of conjugate meningococcal vaccines. To create
the new meningitis vaccine - custom-made for the African
meningitis belt, MVP has signed an agreement with
the Serum Institute of India Limited, Pune. The so-called
conjugate meningitis vaccine A (Men A) is being developed
at the Serum Institute's Lab in Pune, India, applying
a new US Technology supplied by the US Food and Drug
Administration.
KEM Hospital Research Center has been contributing
the project by conducting clinical trials. KEMHRC
has successfully completed phase-II/III clinical trial
of this conjugate meningococcal vaccine (PsA-TT-003a)
at its division Shirdi Saibaba Hospital Vadu, Pune.
Next to Phase-II/III study, Phase -III study of conjugate
meningococcal vaccines ((PsA-TT-005) is being conducted
at Vadu Site.
Study Title:
A phase III, double-blind, randomized, active controlled
study to evaluate the safety, immunogenicity and consistency
of three consecutive lots of a Meningococcal A Conjugate
Vaccine administered as a single dose to healthy children
at 5-10 years of age.
Sponsors:
Serum Institute of India Limited (SIIL) & Program
for Appropriate Technology in Health (PATH).
Total Number of Subject
: 830
Total Study Duration:
32 weeks (approximately)
PsA-TT-005 study:
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. |
