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

Completed · Phase 3

Conditions studied: Acellular Pertussis, Diphtheria, Tetanus

In brief

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.

Key facts

Study ID

NCT00385255

Run by

GlaxoSmithKline

People needed

1726

Starts

2006-10-23

Expected to finish

2007-02-28

Last updated by the study team

2019-06-10

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Huntsville, Alabama, United States
• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Inverness, Florida, United States
• GSK Investigational Site — Melbourne, Florida, United States
• GSK Investigational Site — Pembroke Pines, Florida, United States
• GSK Investigational Site — Peoria, Illinois, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Bristol, Tennessee, United States
• GSK Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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