A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).

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

NCT00382772

107876

Details and patient eligibility

About

The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formulation of GSK Biologicals' HRV vaccine when administered concomitantly with a combination childhood vaccine.

Sex

All

Ages

11 to 17 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy infants birth weigh >2000 g, 11 -17 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.