Clinical Trials Directory

Trials / Completed

CompletedNCT00753649

Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa Vaccine in Healthy Infants

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
224 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
6 Weeks – 12 Weeks
Healthy volunteers
Accepted

Summary

This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.

Detailed description

This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).

Conditions

Interventions

TypeNameDescription
BIOLOGICALInfanrix™ hexaIntramuscular, three doses

Timeline

Start date
2008-09-23
Primary completion
2013-03-12
Completion
2013-03-12
First posted
2008-09-16
Last updated
2019-11-27
Results posted
2016-11-30

Locations

3 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT00753649. Inclusion in this directory is not an endorsement.