Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
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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.
Condition or disease
Biological: 2-dose oral live attenuated G1P human rotavirus vaccine
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).
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
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Ages Eligible for Study:
6 Weeks to 16 Weeks (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.
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;