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

Primary Purpose

Infections, Rotavirus

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
2-dose oral live attenuated G1P[8] human rotavirus vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Rotavirus focused on measuring HRV vaccine, diarrhoea, rotavirus

Eligibility Criteria

6 Weeks - 16 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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

Assess immunogenicity and safety of HRV vaccine.

Full Information

First Posted
June 7, 2006
Last Updated
November 2, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00334607
Brief Title
Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Rotavirus
Keywords
HRV vaccine, diarrhoea, rotavirus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
484 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
2-dose oral live attenuated G1P[8] human rotavirus vaccine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Assess immunogenicity and safety of HRV vaccine.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
16 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Benton
State/Province
Arkansas
ZIP/Postal Code
72015
Country
United States
Facility Name
GSK Investigational Site
City
Cabot
State/Province
Arkansas
ZIP/Postal Code
72023
Country
United States
Facility Name
GSK Investigational Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
GSK Investigational Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
GSK Investigational Site
City
Lakewood
State/Province
California
ZIP/Postal Code
90711
Country
United States
Facility Name
GSK Investigational Site
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
GSK Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
GSK Investigational Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
GSK Investigational Site
City
DeKalb
State/Province
Illinois
ZIP/Postal Code
60115
Country
United States
Facility Name
GSK Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
GSK Investigational Site
City
Commerce Twp
State/Province
Michigan
ZIP/Postal Code
48382
Country
United States
Facility Name
GSK Investigational Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
GSK Investigational Site
City
Bryson
State/Province
North Carolina
ZIP/Postal Code
28713
Country
United States
Facility Name
GSK Investigational Site
City
Clyde
State/Province
North Carolina
ZIP/Postal Code
28721
Country
United States
Facility Name
GSK Investigational Site
City
Deerfield
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
Facility Name
GSK Investigational Site
City
Franklin
State/Province
North Carolina
ZIP/Postal Code
28734
Country
United States
Facility Name
GSK Investigational Site
City
Laurinburg
State/Province
North Carolina
ZIP/Postal Code
28352
Country
United States
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
GSK Investigational Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
GSK Investigational Site
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
GSK Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
GSK Investigational Site
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44505
Country
United States
Facility Name
GSK Investigational Site
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44514
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
GSK Investigational Site
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
GSK Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
GSK Investigational Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
GSK Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
GSK Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
GSK Investigational Site
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
GSK Investigational Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
GSK Investigational Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
GSK Investigational Site
City
Orem
State/Province
Utah
ZIP/Postal Code
84057
Country
United States
Facility Name
GSK Investigational Site
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
GSK Investigational Site
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
GSK Investigational Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
GSK Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
GSK Investigational Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
18977955
Citation
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.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107531
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107531
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107531
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107531
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107531
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107531
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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