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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00334607
Other study ID # 107531
Secondary ID
Status Completed
Phase Phase 3
First received June 7, 2006
Last updated November 2, 2016
Start date June 2006
Est. completion date June 2007

Study information

Verified date November 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 484
Est. completion date June 2007
Est. primary completion date February 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Weeks to 16 Weeks
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
United States GSK Investigational Site Akron Ohio
United States GSK Investigational Site Benton Arkansas
United States GSK Investigational Site Boardman Ohio
United States GSK Investigational Site Bristol Tennessee
United States GSK Investigational Site Bryan Texas
United States GSK Investigational Site Bryson North Carolina
United States GSK Investigational Site Cabot Arkansas
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Charlottesville Virginia
United States GSK Investigational Site Clyde North Carolina
United States GSK Investigational Site Commerce Twp Michigan
United States GSK Investigational Site Dayton Ohio
United States GSK Investigational Site Deerfield North Carolina
United States GSK Investigational Site DeKalb Illinois
United States GSK Investigational Site East Providence Rhode Island
United States GSK Investigational Site Englewood Colorado
United States GSK Investigational Site Franklin North Carolina
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Jonesboro Arkansas
United States GSK Investigational Site Kingsport Tennessee
United States GSK Investigational Site Lakewood California
United States GSK Investigational Site Laurinburg North Carolina
United States GSK Investigational Site Layton Utah
United States GSK Investigational Site Lebanon New Hampshire
United States GSK Investigational Site Little Rock Arkansas
United States GSK Investigational Site Marshfield Wisconsin
United States GSK Investigational Site North Charleston South Carolina
United States GSK Investigational Site North Little Rock Arkansas
United States GSK Investigational Site Ogden Utah
United States GSK Investigational Site Orem Utah
United States GSK Investigational Site Overland Park Kansas
United States GSK Investigational Site Paramount California
United States GSK Investigational Site Pasadena California
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Providence Rhode Island
United States GSK Investigational Site Provo Utah
United States GSK Investigational Site South Jordan Utah
United States GSK Investigational Site West Jordan Utah
United States GSK Investigational Site Winston-Salem North Carolina
United States GSK Investigational Site Youngstown Ohio
United States GSK Investigational Site Youngstown Ohio

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
Secondary Assess immunogenicity and safety of HRV vaccine.
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