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Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

NCT00480324 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 765

Last updated 2020-01-02

Study results available
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Summary

This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus \[HRV\] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

  • Infections, Rotavirus
  • Rotavirus Vaccines

Interventions

BIOLOGICAL

Rotarix

Two-dose oral vaccination.

BIOLOGICAL

Placebo

Two-dose oral administration.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
14 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-19
Primary Completion
2009-03-31
Completion
2009-11-21

Countries

  • Japan

Study Locations

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Entities

Drugs
Companies

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 NCT00480324 on ClinicalTrials.gov