Clinical Trials Directory

Trials / Completed

CompletedNCT01457560

Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine

Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Mixed With Hib Vaccine in Healthy Infants, Followed by a Dose of the Same Vaccine Administered Simultaneously With One Dose of Oral Polio Vaccine (OPV)

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

Summary

This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.

Conditions

Interventions

TypeNameDescription
BIOLOGICALDTPa-HBV-IPV/Hib (Infanrix hexa™)Three doses administered intramuscularly
BIOLOGICALOPVOne dose administered orally

Timeline

Start date
2000-02-01
Primary completion
2001-04-01
Completion
2001-04-01
First posted
2011-10-24
Last updated
2016-08-05

Source: ClinicalTrials.gov record NCT01457560. Inclusion in this directory is not an endorsement.