Phase 4
N=644
Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®
Pertussis · Tetanus · Diphtheria
Bottom Line
View on ClinicalTrials.gov: NCT00319553 ↗Enrolled (actual)
644
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcome: Primary: Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® — 273; 257; 5; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed (Biological); BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed (Biological)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® |
273; 257; 5; 4; 270; 247 | — |
| PRIMARY Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. |
99; 98; 100; 100 | — |
| PRIMARY Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. |
92; 93; 100; 100 | — |
| PRIMARY Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. |
14.4; 13.5; 26.1; 28.2; 12.4; 13.1 | — |
Summary
This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.
Eligibility Criteria
Inclusion Criteria
- Aged 11 - 18 years of age at the time of vaccination in this trial
- Signed Institutional Review Board (IRB)-approved informed assent / consent form.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For a female, negative serum/urine pregnancy test.
Exclusion Criteria
- Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
- Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc) that is unstable or that might:
- interfere with the ability to participate fully in the study; or
- interfere with evaluation of the vaccine.
- Known or suspected impairment of immunologic function.
- Febrile illness within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38°C) at the time of inclusion.
- History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.
- Known or suspected receipt of a tetanus or diphtheria-containing vaccine within the preceding 2 years.
- Known or suspected receipt of a pertussis-containing vaccine within the preceding 5 years.
- Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other therapy expected to materially alter immune function within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
- Received any vaccine in the 21-day period prior to enrollment or scheduled to receive any vaccination after enrollment and prior to visit 2.
- Suspected or known hypersensitivity to any of the vaccine components or to latex.
Data sourced from ClinicalTrials.gov (NCT00319553). 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.