Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: ADACEL®; Biological: Boostrix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00346073

106316

Details and patient eligibility

About

GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.

Enrollment: 2,337 patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.
• Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).
• Administration of a diphtheria-tetanus (Td) booster within previous five years.
• Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,337 participants in 2 patient groups

Boostrix Group

Experimental group

Description:

Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.

Treatment:

Biological: Boostrix™

Adacel Group

Experimental group

Description:

Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.

Treatment:

Biological: ADACEL®