Rotavirus Vaccine Produced by Butantan Institute
Information source: Butantan Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rotavirus Infections
Intervention: rotavirus vaccine (Biological); placebo (Biological)
Phase: Phase 1
Status: Completed
Sponsored by: Butantan Institute Official(s) and/or principal investigator(s): Alexander R Precioso, MD,PhD, Study Director, Affiliation: Butantan Institute
Summary
The purpose of this study is to describe the safety, tolerability and immunogenicity of the
pentavalent rotavirus vaccine produced by Butantan Institute.
Clinical Details
Official title: Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Number of Participants With Adverse Events.
Secondary outcome: Anti-rotavirus IgA Level.
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- Had received any other licensed vaccines within 2 weeks (for inactivated vaccines) or
4 weeks (for live vaccines) prior to enrollment in this study
Locations and Contacts
Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP, Sao Paulo 05403-000, Brazil
Additional Information
Butantan Institute
Related publications: Higashi HG, Luna E, Precioso AR, Vilela M, Kubrusly FS, Dias WO, Raw I. Acellular and "low" pertussis vaccines: adverse events and the role of mutations. Rev Inst Med Trop Sao Paulo. 2009 May-Jun;51(3):131-4. Review.
Starting date: March 2009
Last updated: March 15, 2013
|