NCT01889836

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

Brazil's Conjugated Vaccine Project Against Meningococcal C. Safety and Immunogenicity Study in Young Adults the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Detailed description

Study design - This is a clinical study Phase I, randomized, double blind with 60 individuals. 30 individuals will receive the experimental vaccine by Bio-Manguinhos/Fiocruz and 30 individuals will receive a meningococcal C conjugated vaccine used in the National Immunization Program. Location of Study - Clinical Trials Unit for Immunobiology by Bio-Manguinhos/Fiocruz. Primary objective - Evaluate the safety of the meningococcal C vaccine by Bio-Manguinhos/Fiocruz for use in humans. Secondary objective - To evaluate the immunogenicity of the meningococcal C vaccine by Bio-Manguinhos in young adults. specific objectives 1. To evaluate the frequency / intensity of adverse events occurring up to 30 days after vaccination. 2. To evaluate the seroconversion defined as pre-immunization serum nonreactive (negative) and post-immunization reactor (positive) antigens, with getting titles 8 (rabbit complement) to the target strain used in the test of bactericidal power of the sera from immunized volunteers, a 4-fold increase in titers following vaccination compared to pre-vaccination and antibody titers after immunization.

Conditions

• Meningitis, Meningococcal, Serogroup C

Interventions

Type	Name	Description
BIOLOGICAL	'MenCC-Bio'	The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos.
BIOLOGICAL	MENJUGATE	The control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE.

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-07-01
• Last updated: 2015-09-16

Locations

1 site across 1 country: Brazil