Phase 3
N=1,042
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
Tetanus · Diphtheria · Pertussis
Bottom Line
View on ClinicalTrials.gov: NCT00467519 ↗Enrolled (actual)
1,042
Serious AEs
0.9%
Results posted
Dec 2010
Primary outcome: Primary: Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level — 65; 69; 100; 100 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis) (Biological); DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed) (Biological)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level |
65; 69; 100; 100; 81; 85 | — |
| PRIMARY Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL |
4; 7; 99; 100; 11; 12 | — |
| PRIMARY Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis |
88; 94; 92; 89; 92; 95 | — |
| PRIMARY Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus |
99; 99; 98; 97 | — |
| PRIMARY Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis |
4.58; 4.98; 53.1; 86.4; 7.56; 7.60 | — |
Summary
Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this formulation as a 5th dose.
Primary Objective:
- To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.
Secondary/Observational Objectives:
* To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine (for pertussis antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.
* To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after each long-term follow-up.
* To describe the safety profile following vaccine administration.
Eligibility Criteria
Inclusion Criteria
- Healthy, as determined by medical history and physical examination.
- Aged 4 to 6 (< 7) years at the time of study vaccination on Day 0.
- Signed and dated informed consent form that has been approved by the Institutional Review Board (IRB) by the parent or legally authorized representative.
- Signed and dated informed assent form from the subject if required by the IRB.
- Able to attend scheduled visits at Visit 1 and Visit 2 and able to comply with all trial procedures. Subjects will be invited to participate in the long-term immunogenicity follow-up study but a commitment to participate in the long-term is not required as an inclusion criterion.
- Documented vaccination history of 4 previous doses of DAPTACEL according to the recommended national immunization schedule for Diphtheria, tetanus and acellular pertussis (DTaP).
Exclusion Criteria
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
- Planned participation in another clinical trial during the original trial period.
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- Systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Blood or blood-derived products received in the past 3 months.
- Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (with the exception of the annual influenza vaccine).
- History of diphtheria, tetanus or pertussis infection (confirmed either serologically or microbiologically).
- Thrombocytopenia or bleeding disorder contraindicating intra muscular vaccination.
Data sourced from ClinicalTrials.gov (NCT00467519). 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.