NCT00729001

Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.

Phase II, Double-blind, Randomized, Placebo-controlled Study of 2 Doses of GSK Biologicals' Live Attenuated Human Rotavirus Vaccine at Different Virus Concentrations (10 5.2 and 10 6.4 Ffu) in Healthy Infants Following a 0, 2 Month Schedule and Previously Uninfected With Human Rotavirus.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 529 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.

Detailed description

All subjects enrolled from Eastern United States and Eastern Canada will continue their participation in the pilot efficacy follow-up (pilot efficacy subset). The third dose of IPV vaccine (IPOL) may be given at visit 3, 4 or another time, at the investigator's discretion. Comvax may be given in place of OmniHIB/ActHIB at Visit 1 and Visit 2 and the third dose of Comvax administered according to the prescribing information.

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
BIOLOGICAL	Human Rotavirus Vaccine - two different formulations	Two oral doses
BIOLOGICAL	Prevnar	Three-dose intramuscular injection (US subjects only)
BIOLOGICAL	IPOL	Two-dose intramuscular injection (US subjects only)
BIOLOGICAL	Infanrix	Three-dose intramuscular injection (US subjects only)
BIOLOGICAL	OmniHIB	Three-dose intramuscular injection (US subjects only)
BIOLOGICAL	Pentacel	Three-dose intramuscular injection (Canada only)

Timeline

• Start date: 2000-11-01
• Primary completion: 2002-09-01
• Completion: 2002-09-01
• First posted: 2008-08-06
• Last updated: 2016-09-16