NCT00981669

Rotavirus Vaccine Produced by Butantan Institute

Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Butantan Institute · Other Government
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.

Detailed description

The Brazilian National Immunization Program (PNI) has introduced a oral monovalent vaccine against rotavirus for infants in its immunization schedule since 2006. Its introduction increased the Brazilian Ministry of Health budget because the vaccination in Brazil is free of charge. An agreement between Path Foundation and Butantan Institute has made possible the transfer of technology to Butantan Institute to produce, at a reduced cost, a pentavalent rotavirus vaccine including the the rotavirus serotypes more frequent in Brazil.

Conditions

• Rotavirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	rotavirus vaccine	3 doses with 6 weeks interval
BIOLOGICAL	placebo	3 doses with 6 weeks interval

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-03-01
• Completion: 2010-06-01
• First posted: 2009-09-22
• Last updated: 2013-04-25
• Results posted: 2013-04-25

Locations

1 site across 1 country: Brazil