Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: Boostrix®; Biological: Fluarix®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00385255

106323

Details and patient eligibility

About

The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a cohort of adults aged greater than or equal to 65 years.

Enrollment: 1,726 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.

Exclusion criteria

• Administration of an influenza vaccine within six months prior to study entry
• Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
• Administration of a Tdap vaccine at any time prior to study entry.
• Administration of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
• History of diphtheria and/or tetanus and/or pertussis disease.
• History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any component of the study vaccines.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,726 participants in 2 patient groups

BOOSTRIX+FLUARIX GROUP

Experimental group

Description:

Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.

Treatment:

Biological: Boostrix®

Biological: Fluarix®

FLUARIX BOOSTRIX GROUP

Experimental group

Description:

Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.

Treatment:

Biological: Boostrix®

Biological: Fluarix®