At a glance
ClinicalIndex Comparison Record- ✓Healthy male or female
- ✓Age 19 to 64 years at study vaccination
- ✕Any prior Tdap vaccine administration
- ✕Td booster within previous 5 years
- ✕Investigational or non-registered product (drug or vaccine) within 30 days before study vaccine
- ✕Chronic immunosuppressants or use within 6 months before study vaccine
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Boostrix™ and ADACEL® for Acellular Pertussis and 2 related conditions. Completed, enrolled 2,337 participants across 42 sites.
Detailed 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.
Study Details
Timeline
Interventions
Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine
Sanofi Pasteur