Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-17

Study Completion Date

2009-10-15

Brief Summary

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This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.

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Detailed Description

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Conditions

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Tetanus Acellular Pertussis Diphtheria Diphtheria-Tetanus-acellular Pertussis Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Boostrix Group

Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)

Group Type EXPERIMENTAL

Boostrix®

Intervention Type BIOLOGICAL

Intramuscular, single dose.

Decavac Group

Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)

Group Type ACTIVE_COMPARATOR

Decavac™

Intervention Type BIOLOGICAL

Intramuscular, single dose.

Interventions

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Boostrix®

Intramuscular, single dose.

Intervention Type BIOLOGICAL

Decavac™

Intramuscular, single dose.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects who the investigator believes that can and will comply with the requirements of the protocol should be enrolled in the study.
* Males or females 65 years of age and older at the time of study entry.
* Free of an acute aggravation of the health status as established by medical history and medical history and clinical examination before entering into the study.
* Written informed consent from all subjects.

Exclusion Criteria

* Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
* Administration of a Tdap vaccine at any time prior to study entry.
* History of diphtheria and/or tetanus and/or pertussis disease.
* Use 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.
* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study, with the exception of influenza, vaccine, which may be administered at any time up to or during the study period, including the day of study vaccination.
* Planned administration of any vaccine not foreseen by the study protocol up to 30 days following vaccination, with the exception of influenza, vaccine, which may be administered at any time up to or during the study period, including the day of study vaccination. Pneumococcal and zoster vaccines can be administered at the discretion of the investigator when the subject comes back at Visit 2.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* History of serious allergic reaction following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.
* History of encephalopathy within seven days of administration of a previous booster dose of pertussis vaccine that is not attributable to another identifiable cause.
* Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.
* Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
* Acute disease at the time of vaccination.
* Administration of immunoglobulins and/or any blood products within the three months preceding vaccination, or planned administration during the study period.
* Any medical condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.

Minimum Eligible Age

65 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

Tucson, Arizona, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

DeLand, Florida, United States

Site Status

GSK Investigational Site

West Palm Beach, Florida, United States

Site Status

GSK Investigational Site

Stockbridge, Georgia, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

Pratt, Kansas, United States

Site Status

GSK Investigational Site

Lexington, Kentucky, United States

Site Status

GSK Investigational Site

Metairie, Louisiana, United States

Site Status

GSK Investigational Site

Columbia, Maryland, United States

Site Status

GSK Investigational Site

Elkridge, Maryland, United States

Site Status

GSK Investigational Site

Milford, Massachusetts, United States

Site Status

GSK Investigational Site

Stevensville, Michigan, United States

Site Status

GSK Investigational Site

High Point, North Carolina, United States

Site Status

GSK Investigational Site

Wilmington, North Carolina, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

GSK Investigational Site

Mogadore, Ohio, United States

Site Status

GSK Investigational Site

Wadsworth, Ohio, United States

Site Status

GSK Investigational Site

Mt. Pleasant, South Carolina, United States

Site Status

GSK Investigational Site

Bristol, Tennessee, United States

Site Status

GSK Investigational Site

Fort Worth, Texas, United States

Site Status

GSK Investigational Site

West Jordan, Utah, United States

Site Status

GSK Investigational Site

Williamsburg, Virginia, United States

Site Status

GSK Investigational Site

Wenatchee, Washington, United States

Site Status

Countries

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United States

References

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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)

Weston WM et al. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Boostrix™): results of a randomized clinical trial. Abstract presented at the 45th National Immunization Conference (NIC). Washington, USA, 28-31 March 2011.

Reference Type BACKGROUND

Study Documents

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