Clinical trial NCT00835237: Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.
Official title: Evaluation of GSK Biologicals' Boostrix® Vaccine When Compared With Decavac™ in Adults Aged 65 Years or Older.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tetanus
Acellular Pertussis
Diphtheria
Diphtheria-Tetanus-acellular Pertussis Vaccines
Keywords: Boostrix®
adults
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 1332
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value
timeFrame: One month after vaccination.
measure: Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
timeFrame: Before (PRE) and one month after vaccination (POST)
Secondary outcomes:
measure: Anti-T and Anti-D Antibody Concentrations
timeFrame: Before (PRE) and one month after vaccination (POST)
measure: Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off
timeFrame: One month after vaccination
measure: Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off
timeFrame: One month after vaccination
measure: Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.
timeFrame: One month after vaccination
measure: Number of Subjects Reporting Solicited Local Symptoms
timeFrame: Within the 4-day (Day 0-3) post-vaccination period
measure: Number of Subjects Reporting Solicited General Symptoms
timeFrame: Within the 4-day (Day 0-3) post-vaccination period
measure: Number of Subjects Reporting Unsolicited Adverse Events (AE)
timeFrame: Within the 31-day (Day 0-30) post-vaccination period
measure: Number of Subjects Reporting Serious Adverse Events (SAE)
timeFrame: From the vaccination up to Day 182
Other outcomes:
Locations:
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: DeLand
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Stockbridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Pratt
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Columbia
country: United States
facility: GSK Investigational Site
state: Maryland
city: Elkridge
country: United States
facility: GSK Investigational Site
state: Maryland
city: Milford
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Stevensville
country: United States
facility: GSK Investigational Site
state: Michigan
city: High Point
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Mogadore
country: United States
facility: GSK Investigational Site
state: Ohio
city: Wadsworth
country: United States
facility: GSK Investigational Site
state: Ohio
city: Mount Pleasant
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: West Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Williamsburg
country: United States
facility: GSK Investigational Site
state: Virginia
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.