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

Phase 3

Completed

• Conditions: Diphtheria; Acellular Pertussis; Tetanus

• Registration Number: NCT00109330
• Lead Sponsor: GlaxoSmithKline

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

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Study First Submitted QC: 2005-04-26
• Study First Submitted: 2005-04-27
• Study First Posted: 2005-04-27
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Norfolk, Virginia, United States