Phase 3
N=2,284
Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
Acellular Pertussis · Diphtheria · Tetanus
Bottom Line
View on ClinicalTrials.gov: NCT00346073 ↗Enrolled (actual)
2,284
Serious AEs
1.5%
Results posted
Aug 2018
Primary outcome: Primary: Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies — 1418; 717; 1439; 728 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Boostrix™ (Biological); ADACEL® (Biological)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies |
1418; 717; 1439; 728 | — |
| PRIMARY Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies |
1420; 723 | — |
| PRIMARY Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations |
63.6; 32.2; 624.4; 368.4; 401.0; 351.9 | — |
| PRIMARY Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies |
1095; 338; 1388; 671; 1343; 665 | — |
| SECONDARY Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies |
1269; 669 | — |
| SECONDARY Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) |
1116; 566; 704; 441 | — |
| SECONDARY Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations |
4.7; 5.0; 8.5; 13.3 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
903; 513; 24; 17; 313; 201 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
416; 214; 37; 9; 251; 151 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
271; 169 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs). |
9; 2 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
12; 11 | — |
| SECONDARY Number of Subjects Reporting Hospitalizations |
13; 10 | — |
| SECONDARY Number of Subjects Reporting Emergency Room Visits |
13; 6 | — |
| SECONDARY Number of Subjects Reporting the Onset of New Chronic Illnesses |
2; 3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00346073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.