NCT00334607

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 484 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 16 Weeks
• Healthy volunteers: Accepted

Summary

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.

Detailed 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).

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
BIOLOGICAL	2-dose oral live attenuated G1P[8] human rotavirus vaccine

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-02-01
• Completion: 2007-06-01
• First posted: 2006-06-08
• Last updated: 2016-11-04

Locations

42 sites across 1 country: United States