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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

Diphtheria
Tetanus
Acellular Pertussis

Treatments

Biological: Combined diphtheria, tetanus, acellular pertussis vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00109330
776423/001

Details and patient eligibility

About

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).

Full description

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

Enrollment

4,116 patients

Sex

All

Ages

10 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

44

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Data sourced from clinicaltrials.gov

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