Clinical Trials Directory

Trials / Completed

CompletedNCT01457547

Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course

Study to Assess and Compare the Immunogenicity and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) and Aventis Pasteur MSD's DTPa-HBV-IPV-Hib Vaccine (HEXAVAC™) Given at 3, 5 and 11-12 Months of Age

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
494 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
8 Weeks – 15 Weeks
Healthy volunteers
Accepted

Summary

The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.

Conditions

Interventions

TypeNameDescription
BIOLOGICALDTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)Three doses administered intramuscularly
BIOLOGICALDTPa-HBV-IPV-Hib vaccine (HEXAVAC™)Three doses administered intramuscularly

Timeline

Start date
2003-10-01
Primary completion
2005-05-01
Completion
2005-05-01
First posted
2011-10-24
Last updated
2016-08-05

Locations

9 sites across 3 countries: Finland, Italy, Sweden

Source: ClinicalTrials.gov record NCT01457547. Inclusion in this directory is not an endorsement.