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

Infections, Rotavirus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334607
• Other study ID #: 107531
• 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

• Infections, Rotavirus
• Rotavirus Infections

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.

External Links

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