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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00109330

Enrollment

4116

Registered

2005-04-27

Start date

2002-11-30

Completion date

2004-04-30

Last updated

2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acellular Pertussis, Diphtheria, Tetanus

Keywords

Prevention of Diphtheria, Tetanus, Pertussis

Brief 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

Interventions

BIOLOGICALCombined diphtheria, tetanus, acellular pertussis vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).

Exclusion criteria

* Use of any other investigational drug or vaccine 30 days preceding study vaccination. * Chronic administration of immunosuppressants. * Administration of pre-school DTP vaccine within previous 5 years. * Administration of Td booster within previous 10 years.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026