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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00467519
First received: April 27, 2007
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.

Condition Intervention Phase
Tetanus
Diphtheria
Pertussis
Biological: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
Biological: DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine as Fifth Dose Booster in Children 4 to 6 Years of Age

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level [ Time Frame: Pre-dose and 30 days post-vaccination ] [ Designated as safety issue: No ]

    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).


  • Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL [ Time Frame: Pre-dose and 30 days post-vaccination ] [ Designated as safety issue: No ]

    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).


  • Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis [ Time Frame: 30 Days post-vaccination ] [ Designated as safety issue: No ]

    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).


  • Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus [ Time Frame: 30 Days post-vaccination ] [ Designated as safety issue: No ]

    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).


  • Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis [ Time Frame: Pre-dose and 30 Days Post-vaccination ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination [ Time Frame: Days 0 to 7 post-vaccination ] [ Designated as safety issue: No ]
    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.


Enrollment: 1045
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
DAPTACEL primed participants
Biological: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
0.5 mL, IM
Other Name: Adacel
Experimental: Group 2
Pentacel primed participants
Biological: DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
0.5 mL, IM
Other Names:
  • DAPTACEL in the US
  • TRIPACEL in Canada

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467519

  Show 43 Study Locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00467519     History of Changes
Other Study ID Numbers: TD517
Study First Received: April 27, 2007
Results First Received: November 4, 2010
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014