Infections, Rotavirus
Conditions
Keywords
HRV vaccine, diarrhoea, rotavirus
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).
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 16 Weeks
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess immunogenicity and safety of HRV vaccine. | — |
Countries
United States
Outcome results
None listed