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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1726 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-23

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Acellular Pertussis Diphtheria Tetanus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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BOOSTRIX+FLUARIX GROUP

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.

Group Type EXPERIMENTAL

Fluarix®

Intervention Type BIOLOGICAL

GSK Biologicals' inactivated influenza split virus vaccine.

Boostrix®

Intervention Type BIOLOGICAL

GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.

FLUARIX BOOSTRIX GROUP

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.

Group Type EXPERIMENTAL

Fluarix®

Intervention Type BIOLOGICAL

GSK Biologicals' inactivated influenza split virus vaccine.

Boostrix®

Intervention Type BIOLOGICAL

GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.

Interventions

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Fluarix®

GSK Biologicals' inactivated influenza split virus vaccine.

Intervention Type BIOLOGICAL

Boostrix®

GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Huntsville, Alabama, United States

Site Status

GSK Investigational Site

Chandler, Arizona, United States

Site Status

GSK Investigational Site

Mesa, Arizona, United States

Site Status

GSK Investigational Site

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

Inverness, Florida, United States

Site Status

GSK Investigational Site

Melbourne, Florida, United States

Site Status

GSK Investigational Site

Pembroke Pines, Florida, United States

Site Status

GSK Investigational Site

Peoria, Illinois, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Bristol, Tennessee, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

Countries

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United States

References

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Weston WM, Chandrashekar V, Friedland LR, Howe B. Safety and immunogenicity of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine when co-administered with influenza vaccine in adults. Hum Vaccin. 2009 Dec;5(12):858-66. doi: 10.4161/hv.9961. Epub 2009 Dec 31.

Reference Type BACKGROUND

PMID: 19838080 (View on PubMed)

Weston WM, Friedland LR, Wu X, Howe B. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix((R))): results of two randomized trials. Vaccine. 2012 Feb 21;30(9):1721-8. doi: 10.1016/j.vaccine.2011.12.055. Epub 2011 Dec 31.

Reference Type BACKGROUND

PMID: 22212127 (View on PubMed)

Study Documents

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