Clinical Trials Directory

Trials / Terminated

TerminatedNCT00544271

Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.

Phase IIIb Study to Evaluate Immunogenicity, Antibody Persistency and Reactogenicity of DTPa - INFANRIX and dTpa - BOOSTRIX Vaccines Administered to Healthy Children Previously Primed With 3 Doses of DTPa Vaccine Compared to Placebo (HAVRIX®JUNIOR)

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
720 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
18 Months – 20 Months
Healthy volunteers
Accepted

Summary

To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.

Conditions

Interventions

TypeNameDescription
BIOLOGICALINFANRIX
BIOLOGICALBOOSTRIX
BIOLOGICALHAVRIX

Timeline

Start date
2003-05-01
Completion
2004-01-01
First posted
2007-10-16
Last updated
2016-09-07

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT00544271. Inclusion in this directory is not an endorsement.