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

NCT ID: NCT00334607

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Infections, Rotavirus

Keywords

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HRV vaccine diarrhoea rotavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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2-dose oral live attenuated G1P[8] human rotavirus vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

16 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Benton, Arkansas, United States

Site Status

GSK Investigational Site

Cabot, Arkansas, United States

Site Status

GSK Investigational Site

Jonesboro, Arkansas, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

North Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

Lakewood, California, United States

Site Status

GSK Investigational Site

Paramount, California, United States

Site Status

GSK Investigational Site

Pasadena, California, United States

Site Status

GSK Investigational Site

Englewood, Colorado, United States

Site Status

GSK Investigational Site

DeKalb, Illinois, United States

Site Status

GSK Investigational Site

Overland Park, Kansas, United States

Site Status

GSK Investigational Site

Commerce Twp, Michigan, United States

Site Status

GSK Investigational Site

Lebanon, New Hampshire, United States

Site Status

GSK Investigational Site

Bryson City, North Carolina, United States

Site Status

GSK Investigational Site

Clyde, North Carolina, United States

Site Status

GSK Investigational Site

Deerfield, North Carolina, United States

Site Status

GSK Investigational Site

Franklin, North Carolina, United States

Site Status

GSK Investigational Site

Laurinburg, North Carolina, United States

Site Status

GSK Investigational Site

Winston-Salem, North Carolina, United States

Site Status

GSK Investigational Site

Akron, Ohio, United States

Site Status

GSK Investigational Site

Boardman, Ohio, United States

Site Status

GSK Investigational Site

Dayton, Ohio, United States

Site Status

GSK Investigational Site

Youngstown, Ohio, United States

Site Status

GSK Investigational Site

Youngstown, Ohio, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

East Providence, Rhode Island, United States

Site Status

GSK Investigational Site

Providence, Rhode Island, United States

Site Status

GSK Investigational Site

Charleston, South Carolina, United States

Site Status

GSK Investigational Site

Charleston, South Carolina, United States

Site Status

GSK Investigational Site

North Charleston, South Carolina, United States

Site Status

GSK Investigational Site

Bristol, Tennessee, United States

Site Status

GSK Investigational Site

Kingsport, Tennessee, United States

Site Status

GSK Investigational Site

Bryan, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Layton, Utah, United States

Site Status

GSK Investigational Site

Ogden, Utah, United States

Site Status

GSK Investigational Site

Orem, Utah, United States

Site Status

GSK Investigational Site

Provo, Utah, United States

Site Status

GSK Investigational Site

South Jordan, Utah, United States

Site Status

GSK Investigational Site

West Jordan, Utah, United States

Site Status

GSK Investigational Site

Charlottesville, Virginia, United States

Site Status

GSK Investigational Site

Marshfield, Wisconsin, United States

Site Status

Countries

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United States

References

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Dennehy PH, Bertrand HR, Silas PE, Damaso S, Friedland LR, Abu-Elyazeed R. Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics. 2008 Nov;122(5):e1062-6. doi: 10.1542/peds.2008-1059.

Reference Type BACKGROUND
PMID: 18977955 (View on PubMed)

Study Documents

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Document Type: Dataset Specification

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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107531

Identifier Type: -

Identifier Source: org_study_id