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Rotavirus Vaccine Produced by Butantan Institute

NCT00981669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-04-25

Study results available
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Summary

The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.

Conditions

  • Rotavirus Infections

Interventions

BIOLOGICAL

rotavirus vaccine

3 doses with 6 weeks interval

BIOLOGICAL

placebo

3 doses with 6 weeks interval

Sponsors & Collaborators

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Alexander R Precioso, MD,PhD · Butantan Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-03-31
Completion
2010-06-30

Countries

  • Brazil

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00981669 on ClinicalTrials.gov