Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
Phase 3
Completed
- Conditions
- Infections, Rotavirus
- Registration Number
- NCT00334607
- Lead Sponsor
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 484
Inclusion Criteria
- Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Assess immunogenicity and safety of HRV vaccine.
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Marshfield, Wisconsin, United States