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

NCT00467519 | Completed Phase 3 Results

• 1 other identifier: TD517
• Study Type: interventional
• Target: 1,045
• Locations: 2 countries
• Sites: 43

Brief 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.

Conditions

Tetanus; Diphtheria; Pertussis

Keywords

Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (1)

• Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination

  Days 0 to 7 post-vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

DAPTACEL primed participants

Biological: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)

Group 2

EXPERIMENTAL

Pentacel primed participants

Biological: DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)

Interventions

Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis) BIOLOGICAL

0.5 mL, IM

Also known as: Adacel

Group 1

DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed) BIOLOGICAL

0.5 mL, IM

Also known as: DAPTACEL in the US, TRIPACEL in Canada

Group 2

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Documented vaccination history of 4 previous doses of DAPTACEL according to the recommended national immunization schedule for Diphtheria, tetanus and acellular pertussis (DTaP).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (43)

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Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 35244, United States

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Fayetteville, Arkansas, 72703, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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Fountain Valley, California, 92708, United States

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Huntington Beach, California, 92647, United States

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Oakland, California, 94611, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95815, United States

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Norwich, Connecticut, 06360, United States

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Marietta, Georgia, 30062, United States

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Woodstock, Georgia, 30189, United States

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Bardstown, Kentucky, 40004, United States

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Crestview Hills, Kentucky, 41017, United States

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Louisville, Kentucky, 40291, United States

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Bossier City, Louisiana, 71111, United States

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Frederick, Maryland, 21702, United States

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Bellevue, Nebraska, 68123, United States

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Omaha, Nebraska, 68124, United States

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Omaha, Nebraska, 68131, United States

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Omaha, Nebraska, 68132, United States

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Rochester, New York, 14618, United States

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Fargo, North Dakota, 58103, United States

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Cleveland, Ohio, 44121, United States

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Gresham, Oregon, 97030, United States

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Erie, Pennsylvania, 16505, United States

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Norristown, Pennsylvania, 19401, United States

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Pittsburgh, Pennsylvania, 15236, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Rydal, Pennsylvania, 19046, United States

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Uniontown, Pennsylvania, 15401, United States

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Kingsport, Tennessee, 37660, United States

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Tullahoma, Tennessee, 37388, United States

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San Antonio, Texas, 78229, United States

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Layton, Utah, 84041, United States

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Springville, Utah, 84663, United States

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Chesapeake, Virginia, 23321, United States

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Midlothian, Virginia, 23113, United States

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Spokane, Washington, 99202, United States

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Spokane, Washington, 99218, United States

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La Crosse, Wisconsin, 54601, United States

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Edmonton, Alberta, T6G 2C8, Canada

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Related Links

• Related Info

MeSH Terms

Conditions

Tetanus; Diphtheria; Whooping Cough

Interventions

adacel; Tetanus Toxoid; Diphtheria-Tetanus-acellular Pertussis Vaccines

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Pertussis Vaccine; Bacterial Vaccines; Diphtheria Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: April 30, 2007
• Study Start: April 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 7, 2014
• Results First Posted: December 3, 2010

Record last verified: 2014-01

Locations

US (42); CA (1)