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Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation
The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.
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.
Age
18 - 40 years
Sex
MALE
Healthy Volunteers
Yes
Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP
São Paulo, São Paulo, Brazil
Start Date
March 1, 2009
Primary Completion Date
March 1, 2010
Completion Date
June 1, 2010
Last Updated
April 25, 2013
80
ACTUAL participants
rotavirus vaccine
BIOLOGICAL
placebo
BIOLOGICAL
Lead Sponsor
Butantan Institute
NCT06962904
NCT03483116
NCT02542462
Data Source & Attribution
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