Trials / Completed
CompletedNCT00346073
Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,337 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 19 Years – 64 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Boostrix™ | Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine |
| BIOLOGICAL | ADACEL® | Sanofi Pasteur |
Timeline
- Start date
- 2006-07-13
- Primary completion
- 2007-03-01
- Completion
- 2007-03-07
- First posted
- 2006-06-29
- Last updated
- 2018-08-07
- Results posted
- 2018-08-07
Locations
42 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00346073. Inclusion in this directory is not an endorsement.