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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

Page last updated: August 23, 2015

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