Clinical trial NCT00346073: Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
Official title: A Study to Evaluate Immunogenicity and Safety of Boostrix Compared to Adacel When Administered as a Booster Vaccination in Adults Aged 19 to 64 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acellular Pertussis
Diphtheria
Tetanus
Keywords: Prophylaxis for diphtheria, tetanus, pertussis
Immunogenicity, booster, dTpa
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-29
Enrollment: 2337
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.


Eligibility criteria: Inclusion Criteria:

* A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.
* Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).
* Administration of a diphtheria-tetanus (Td) booster within previous five years.
* Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.

Primary outcomes:
measure: Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
timeFrame: At Month 1
measure: Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies
timeFrame: At Month 1
measure: Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
timeFrame: At Month 1
measure: Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
timeFrame: At Month 1
Secondary outcomes:
measure: Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies
timeFrame: At Month 1
measure: Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)
timeFrame: At Month 1
measure: Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
timeFrame: At Month 1
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 15-day period (Day 0-14) following vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 15-day period (Day 0-14) following vaccination
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day period (Days 0-30) following vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs).
timeFrame: During the active phase of the study (Day 0 - Day 30)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the extended safety follow-up (ESFU) phase (Day 31 - Month 6)
measure: Number of Subjects Reporting Hospitalizations
timeFrame: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
measure: Number of Subjects Reporting Emergency Room Visits
timeFrame: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
measure: Number of Subjects Reporting the Onset of New Chronic Illnesses
timeFrame: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Peoria
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tempe
country: United States
facility: GSK Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Pueblo
country: United States
facility: GSK Investigational Site
state: Colorado
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Melbourne
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Boise
country: United States
facility: GSK Investigational Site
state: Idaho
city: Peoria
country: United States
facility: GSK Investigational Site
state: Illinois
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Richland
country: United States
facility: GSK Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Alliance
country: United States
facility: GSK Investigational Site
state: Nebraska
city: North Platte
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Hickory
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: GSK Investigational Site
state: North Dakota
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Grove City
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: West Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Blatter M, Friedland LR, Weston WM, Li P, Howe B. Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19-64 years of age. Vaccine. 2009 Jan 29;27(5):765-72. doi: 10.1016/j.vaccine.2008.11.028. Epub 2008 Nov 27.