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The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavelent roatavirus vaccine produced by Butantan Institute.
The Bazilian 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 pentavelent rotavirus vaccine including the the rotavirus serotypes more frequent in Brazil.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
rotavirus vaccine, placebo
Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:19:11-0400
This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.
This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.
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Vaccines or candidate vaccines used to prevent infection with ROTAVIRUS.
A genus of REOVIRIDAE, causing acute gastroenteritis in BIRDS and MAMMALS, including humans. Transmission is horizontal and by environmental contamination. Seven species (Rotaviruses A thru G) are recognized.
A family of unenveloped RNA viruses with cubic symmetry. The twelve genera include ORTHOREOVIRUS; ORBIVIRUS; COLTIVIRUS; ROTAVIRUS; Aquareovirus, Cypovirus, Phytoreovirus, Fijivirus, Seadornavirus, Idnoreovirus, Mycoreovirus, and Oryzavirus.
Infection with any of the rotaviruses. Specific infections include human infantile diarrhea, neonatal calf diarrhea, and epidemic diarrhea of infant mice.
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...
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