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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
484
Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
Assess immunogenicity and safety of HRV vaccine.
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GSK Investigational Site
Benton, Arkansas, United States
GSK Investigational Site
Cabot, Arkansas, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
North Little Rock, Arkansas, United States
GSK Investigational Site
Lakewood, California, United States
GSK Investigational Site
Paramount, California, United States
GSK Investigational Site
Pasadena, California, United States
GSK Investigational Site
Englewood, Colorado, United States
GSK Investigational Site
DeKalb, Illinois, United States
...and 32 more locations