Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA

November 2, 2016 updated by: GlaxoSmithKline

Assess the Immunogenicity of 3 Doses of Pediarix®, Prevnar® & ActHIB® Given to Healthy Infants When Administered With GSK Biologicals' 2 Dose Oral Live Attenuated Human Rotavirus Vaccine Given During the Same Vaccination Visit or Separately

The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when administered with GlaxoSmithKline (GSK) Biologicals' two-dose oral live attenuated human rotavirus (HRV) vaccine given during the same vaccination visit (at 2 and 4 months of age) or given separately (at 3 and 5 months of age).

Study Type

Interventional

Enrollment (Actual)

484

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

  • United States
    • Arkansas
      • Benton, Arkansas, United States, 72015
        • GSK Investigational Site
      • Cabot, Arkansas, United States, 72023
        • GSK Investigational Site
      • Jonesboro, Arkansas, United States, 72401
        • GSK Investigational Site
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
      • North Little Rock, Arkansas, United States, 72117
        • GSK Investigational Site
    • California
      • Lakewood, California, United States, 90711
        • GSK Investigational Site
      • Paramount, California, United States, 90723
        • GSK Investigational Site
      • Pasadena, California, United States, 91107
        • GSK Investigational Site
    • Colorado
      • Englewood, Colorado, United States, 80112
        • GSK Investigational Site
    • Illinois
      • DeKalb, Illinois, United States, 60115
        • GSK Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • GSK Investigational Site
    • Michigan
      • Commerce Twp, Michigan, United States, 48382
        • GSK Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • GSK Investigational Site
    • North Carolina
      • Bryson, North Carolina, United States, 28713
        • GSK Investigational Site
      • Clyde, North Carolina, United States, 28721
        • GSK Investigational Site
      • Deerfield, North Carolina, United States, 28607
        • GSK Investigational Site
      • Franklin, North Carolina, United States, 28734
        • GSK Investigational Site
      • Laurinburg, North Carolina, United States, 28352
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44304
        • GSK Investigational Site
      • Boardman, Ohio, United States, 44512
        • GSK Investigational Site
      • Dayton, Ohio, United States, 45406
        • GSK Investigational Site
      • Youngstown, Ohio, United States, 44514
        • GSK Investigational Site
      • Youngstown, Ohio, United States, 44505
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • GSK Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • GSK Investigational Site
      • Providence, Rhode Island, United States, 02903
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29412
        • GSK Investigational Site
      • Charleston, South Carolina, United States, 29407
        • GSK Investigational Site
      • North Charleston, South Carolina, United States, 29405
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • GSK Investigational Site
    • Texas
      • Bryan, Texas, United States, 77802
        • GSK Investigational Site
      • Houston, Texas, United States, 77074
        • GSK Investigational Site
    • Utah
      • Layton, Utah, United States, 84041
        • GSK Investigational Site
      • Ogden, Utah, United States, 84405
        • GSK Investigational Site
      • Orem, Utah, United States, 84057
        • GSK Investigational Site
      • Provo, Utah, United States, 84604
        • GSK Investigational Site
      • South Jordan, Utah, United States, 84095
        • GSK Investigational Site
      • West Jordan, Utah, United States, 84088
        • GSK Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • GSK Investigational Site
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • 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 3 months (Child)

Accepts Healthy Volunteers

Yes

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.

Secondary Outcome Measures

Outcome Measure
Assess immunogenicity and safety of HRV vaccine.

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

June 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

June 7, 2006

First Submitted That Met QC Criteria

June 7, 2006

First Posted (Estimate)

June 8, 2006

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107531

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. Dataset Specification
    Information identifier: 107531
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: 107531
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: 107531
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: 107531
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 107531
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: 107531
    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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