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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
3 doses with 6 weeks interval
3 doses with 6 weeks interval
Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP
São Paulo, São Paulo, Brazil
Number of Participants With Adverse Events.
Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.
Time frame: Within the first five days post-vaccination.
Anti-rotavirus IgA Level.
It was evaluated by anti-rotavirus IgA levels in terms of optical density. Pre-vaccination levels of anti-rotavirus antibodies were not considered as an exclusion criterion. Seroconversion was considered as a fourfold increase in IgA titers. The proportion of seroconverters in both groups was compared. IgA levels in optical density were not converted to any unit of measure.
Time frame: before each dose (total of doses:3) and after 6 weeks of the third dose
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