Clinical Trials Directory

Trials / Completed

CompletedNCT00109330

A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine

A Phase III, Observer-blinded Randomised, Multi-centre Clinical Study of the Safety, Immunogenicity and Consistency of Three Manufacturing Lots of GSK Biologicals' Candidate Tdap Vaccine as Compared to a US-licensed Td Vaccine When Given as a Booster Dose to Healthy Adolescents (10-18 Years of Age)

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
4,116 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
10 Years – 18 Years
Healthy volunteers
Accepted

Summary

This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).

Detailed description

A combined Tdap (Tetanus, Diphteria, Acellular Pertussis) Vaccine Used as a Booster compared to Licensed Td (Tetanus and Diphteria) vaccine

Conditions

Interventions

TypeNameDescription
BIOLOGICALCombined diphtheria, tetanus, acellular pertussis vaccine

Timeline

Start date
2002-11-01
Primary completion
2004-04-01
Completion
2004-04-01
First posted
2005-04-27
Last updated
2016-09-09

Locations

44 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00109330. Inclusion in this directory is not an endorsement.