Last updated: 11/07/2018 01:24:58
Safety and immunogenicity of GSK's Tdap vaccine (Boostrix) in adults aged 19 to 64 years
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Number of seroprotected subjects with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibodies
Timeframe: At Month 1
Number of seropositive subjects with anti-tetanus (anti-T) antibodies
Timeframe: At Month 1
Anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations
Timeframe: At Month 1
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:
Number of seropositive subjects with anti-diphteria (anti-D) antibodies
Timeframe: At Month 1
Number of subjects with booster responses for anti-diphteria (anti-D) and anti-tetanus (anti-T)
Timeframe: At Month 1
Anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations
Timeframe: At Month 1
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 15-day period (Day 0-14) following vaccination
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 15-day period (Day 0-14) following vaccination
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: During the 31-day period (Days 0-30) following vaccination
Number of subjects with serious adverse events (SAEs).
Timeframe: During the active phase of the study (Day 0 - Day 30)
Number of subjects with serious adverse events (SAEs)
Timeframe: During the extended safety follow-up (ESFU) phase (Day 31 - Month 6)
Number of subjects reporting hospitalizations
Timeframe: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
Number of subjects reporting Emergency Room visits
Timeframe: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
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)
Interventions:
Enrollment:
2337
Primary completion date:
2007-07-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Blatter M et al. (2009) Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19–64 years of age. Vaccine. 27 (5): 765-772.
Medical condition
acellular pertussis, Diphtheria, Tetanus
Product
SB776423
Collaborators
Not applicable
Study date(s)
July 2006 to March 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
19 - 64 years
Accepts healthy volunteers
Yes
- A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Study Complete
Location
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828
Status
Study Complete
Location
GSK Investigational Site
Pueblo, Colorado, United States, 81001
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Status
Study Complete
Showing 1 - 6 of 42 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2007-07-03
Actual study completion date
2007-07-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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