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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00334607
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Infections, Rotavirus Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : June 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : June 2007



Primary Outcome Measures :
  1. 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 :
  1. Assess immunogenicity and safety of HRV vaccine.


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 16 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334607


Locations
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United States, Arkansas
GSK Investigational Site
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
United States, California
GSK Investigational Site
Lakewood, California, United States, 90711
GSK Investigational Site
Paramount, California, United States, 90723
GSK Investigational Site
Pasadena, California, United States, 91107
United States, Colorado
GSK Investigational Site
Englewood, Colorado, United States, 80112
United States, Illinois
GSK Investigational Site
DeKalb, Illinois, United States, 60115
United States, Kansas
GSK Investigational Site
Overland Park, Kansas, United States, 66202
United States, Michigan
GSK Investigational Site
Commerce Twp, Michigan, United States, 48382
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
GSK Investigational Site
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
United States, Ohio
GSK Investigational Site
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, 44505
GSK Investigational Site
Youngstown, Ohio, United States, 44514
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, Rhode Island
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
GSK Investigational Site
Providence, Rhode Island, United States, 02903
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29407
GSK Investigational Site
Charleston, South Carolina, United States, 29412
GSK Investigational Site
North Charleston, South Carolina, United States, 29405
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
GSK Investigational Site
Bryan, Texas, United States, 77802
GSK Investigational Site
Houston, Texas, United States, 77074
United States, Utah
GSK Investigational Site
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
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22911
United States, Wisconsin
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 107531
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 107531
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 107531
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 107531
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 107531
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 107531
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00334607    
Other Study ID Numbers: 107531
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by GlaxoSmithKline:
HRV vaccine
diarrhoea
rotavirus
Additional relevant MeSH terms:
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Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases