Status:
COMPLETED
Rotavirus Vaccine Produced by Butantan Institute
Lead Sponsor:
Butantan Institute
Conditions:
Rotavirus Infections
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.
Detailed Description
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 Brazili...
Eligibility Criteria
Inclusion
- Male healthy
- Age ≥18-40 years
- Not taking immunosuppressive drugs
- No clinical history of gastrointestinal diseases or surgeries
- No history of cardiac, neurologic, immunologic or endocrine diseases
- Normal eligibility laboratory tests
- To be willing to participate and sign the informed consent form
- No participation in another clinical trial in the past 6 months
Exclusion
- Had received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00981669
Start Date
March 1 2009
End Date
June 1 2010
Last Update
April 25 2013
Active Locations (1)
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1
Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP
São Paulo, São Paulo, Brazil, 05403-000