Rotavirus Vaccine Produced by Butantan Institute
Summary
The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavelent roatavirus vaccine produced by Butantan Institute.
Description
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Conditions
Rotavirus
Intervention
rotavirus vaccine, placebo
Location
Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP
Sao Paulo
Brazil
05403-000
Status
Active, not recruiting
Source
Butantan Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00981669
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:19:11-0400
Clinical Trials
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This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.
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Optimising Rotavirus Vaccine in Aboriginal Children
Australian Indigenous children, particularly those living in remote communities, suffer a disproportionately high burden of rotavirus gastroenteritis disease. Despite the introduction of r...
PubMed Articles
Human Neonatal Rotavirus Vaccine (RV3-BB) to Target Rotavirus from Birth.
A strategy of administering a neonatal rotavirus vaccine at birth to target early prevention of rotavirus gastroenteritis may address some of the barriers to global implementation of a rotavirus vacci...
Monovalent rotavirus vaccine (RV1) was introduced in Tanzania in January 2013 under the Reach Every Child initiative, to be given at ages 6 and 10 weeks. We used the sentinel hospital rotavirus surv...
Early impact of rotavirus vaccination in children less than five years of age in Mozambique.
Mozambique introduced rotavirus vaccine (Rotarix, GSK Biologicals) in the National Immunization Program in September 2015 with the objective of reducing the burden of total diarrheal disease and speci...
Research progress in rotavirus VP4 subunit vaccine.
Rotaviruses are leading causes of worldwide acute diarrhea in children younger than 5 years old, with severe consequence of social and economic burden. Vaccination is the most effective way to control...
Hospitalizations for rotavirus and acute gastroenteritis (AGE) have declined in the US with rotavirus vaccination, though biennial peaks in incidence in children aged less than 5 years occur. This pat...
Medical and Biotech [MESH] Definitions
Rotavirus Vaccines
Vaccines or candidate vaccines used to prevent infection with ROTAVIRUS.
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.
Reoviridae
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.
Rotavirus Infections
Infection with any of the rotaviruses. Specific infections include human infantile diarrhea, neonatal calf diarrhea, and epidemic diarrhea of infant mice.
Diphtheria-tetanus Vaccine
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.
