Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age

Tetanus Clinical Trial

Official title:

Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine as Fifth Dose Booster in Children 4 to 6 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467519
• Other study ID #: TD517
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2007
• Last updated: January 10, 2014
• Start date: April 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1045
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Tetanus

Intervention

Biological:
• Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
0.5 mL, IM
• DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
0.5 mL, IM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination	Solicited Injection Site Reactions: Pain, erythema/redness, swelling, increased left limb circumference, and increased right limb circumference. Solicited Systemic Reactions: Fever (temperature), headache, malaise, and myalgia.	Days 0 to 7 post-vaccination	No
Primary	Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at = 0.1 IU/mL Level	Seroprotection rate at level = 0.1 IU/mL was defined as antibody concentrations = 0.1 IU/mL.; Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).	Pre-dose and 30 days post-vaccination	No
Primary	Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level = 1.0 IU/mL	Serothreshold rate at level = 1.0 IU/mL was defined as antibody concentrations = 1.0 IU/mL.; Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).	Pre-dose and 30 days post-vaccination	No
Primary	Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis	Booster response was defined as post titer = 0.4 IU/mL and pre-titer < 0.1 IU/mL, or Post/Pre titer = 4 increase and pre titer = 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer = 2 increase and pre-titer = 2 IU/mL; Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).	30 Days post-vaccination	No
Primary	Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus	Booster response was defined as post titer = 0.4 IU/mL and pre titer < 0.1 IU/mL, or Post/Pre titer = 4 increase and pre-titer = 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer = 2 increase and pre-titer = 2 IU/mL.; Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA).	30 Days post-vaccination	No
Primary	Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis	Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).	Pre-dose and 30 Days Post-vaccination	No

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