Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

October 27, 2016 updated by: GlaxoSmithKline

A Multi-country & Multi-center Study to Assess the Efficacy, Immunogenicity & Safety of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.

Study Type

Interventional

Enrollment

6360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5000
        • GSK Investigational Site
      • Córdova, Argentina, 5016
        • GSK Investigational Site
      • La Plata, Argentina, 1900
        • GSK Investigational Site
      • Mendoza, Argentina, 5500
        • GSK Investigational Site
    • Córdova
      • Colonia Caroya, Córdova, Argentina, X5223CDT
        • GSK Investigational Site
      • Rio Cuarto, Córdova, Argentina, 5800
        • GSK Investigational Site
    • Mendoza
      • Tunuyan, Mendoza, Argentina, 5560
        • GSK Investigational Site
      • Villanueva, Mendoza, Argentina, 5521
        • GSK Investigational Site
  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • GSK Investigational Site
  • Colombia
      • Bogota, Colombia, 805
        • GSK Investigational Site
      • Cali, Colombia
        • GSK Investigational Site
      • Cali Colombia, Colombia
        • GSK Investigational Site
  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • GSK Investigational Site
    • Sant Dom- Distrito Nacional
      • Santo Domingo, Distrito Nacional, Sant Dom- Distrito Nacional, Dominican Republic
        • GSK Investigational Site
  • Honduras
      • Comayaguela, Honduras
        • GSK Investigational Site
  • Panama
      • Panama, Panama
        • GSK Investigational Site
    • Chiriquí
      • David, Chiriquí, Panama, Panamá 937, David
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.

Exclusion criteria:

  • Allergic reaction to vaccine components;
  • clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
  • immunocompromised.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.

Secondary Outcome Measures

Outcome Measure
Vaccine efficacy against severe rotavirus gastroenteritis by serotypes until 1 year of age; Safety; Immunogenicity of HRV and co-administered EPI vaccines

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 444563/024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: 444563/024
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: 444563/024
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: 444563/024
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: 444563/024
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: 444563/024
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: 444563/024
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: 444563/024
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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