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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Infections, Rotavirus

Treatments

Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00334607

107531

Details and patient eligibility

About

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.

Full 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).

Enrollment

484 patients

Sex

All

Ages

6 to 16 weeks old

Volunteers

Accepts Healthy Volunteers

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.