Safety and Immunogenicity Study in Young Adults the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos

Summary

Clinical trial phase I, randomized, double blind, where 30 individuals will receive the experimental vaccine while 30 other volunteers will receive a meningococcal C conjugate vaccine already licensed in Brazil and available in the National Immunization Program for children less than 12 months of age. The primary outcome of the study is to evaluate the safety profile of the vaccine under test, which should allow its application in humans. Secondly, the investigators will study its immunogenicity from the evaluation of the correlates of seroprotection for meningococcal, defined by the World Health Organization (WHO).

Timeline

Start

2014-05

Primary completion

2014-12

Completion

2014-12

Drugs

Indications