Rotavirus Infections Clinical Trial
Official title:
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. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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