Contract research firm iGATE Clinical Research International today completed the Phase I clinical trial of a new meningococcal-A conjugate vaccine.
The project, which is being done in partnership between the World Health Organization (WHO) and the Program for Appropriate Technology in Health (PATH), an American NGO based in Seattle aimed at eliminating epidemic meningitis in sub-Saharan Africa.
Vaccine development partners include the Center for Biologics Evaluation and Research (CBER - a centre of the United States Food and Drug Administration for conjugation technology, and Serum Institute of India Limited (SIIL) for vaccine manufacturing, a company release said here today.
IGATE CRI was awarded a five-year contract by Meningitis Vaccine Project (MVP) for clinical trial services spanning Phase I to Phase III testing that will include seven clinical trials.
The new meningococcal A vaccine is manufactured by Serum Institute of India Limited (SIIL).
IGATE CRI commenced monitoring Phase I trials in September 2004 in India and expects to initiate work on Phase II trials this year. The Phase I trial of the new vaccine was conducted in 72 subjects across three sites in India, the release said.