Rotavirus Vaccine Produced by Butantan Institute

NCT ID: NCT00981669

Last Updated: 2013-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-06-30

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 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.

Conditions

Rotavirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

rotavirus vaccine

3 doses with 6 weeks interval

Group Type: EXPERIMENTAL

rotavirus vaccine

Intervention Type: BIOLOGICAL

3 doses with 6 weeks interval

placebo

3 doses with 6 weeks interval

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

3 doses with 6 weeks interval

Interventions

rotavirus vaccine

3 doses with 6 weeks interval

Intervention Type: BIOLOGICAL

placebo

3 doses with 6 weeks interval

Intervention Type: BIOLOGICAL

Other Intervention Names

brazilian rotavirus vaccine; butantan placebo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Butantan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander R Precioso, MD,PhD

Role: STUDY_DIRECTOR

Butantan Institute

Locations

Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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. doi: 10.1590/s0036-46652009000300002.

Reference Type: BACKGROUND

PMID: 19551286 (View on PubMed)

Other Identifiers

1242/06

Identifier Type: -

Identifier Source: org_study_id