Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00467519
Recruitment Status : Completed
First Posted : April 30, 2007
Results First Posted : December 3, 2010
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1045 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

    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).


  2. 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 ]

    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).


  3. Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis [ Time Frame: 30 Days post-vaccination ]

    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).


  4. Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus [ Time Frame: 30 Days post-vaccination ]

    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).


  5. Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis [ Time Frame: Pre-dose and 30 Days Post-vaccination ]
    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:
  1. Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination [ Time Frame: Days 0 to 7 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467519


Locations
Layout table for location information
United States, Alabama
Birmingham, Alabama, United States, 35205
Birmingham, Alabama, United States, 35244
United States, Arkansas
Fayetteville, Arkansas, United States, 72703
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72205
United States, California
Fountain Valley, California, United States, 92708
Huntington Beach, California, United States, 92647
Oakland, California, United States, 94611
Roseville, California, United States, 95661
Sacramento, California, United States, 95815
United States, Connecticut
Norwich, Connecticut, United States, 06360
United States, Georgia
Marietta, Georgia, United States, 30062
Woodstock, Georgia, United States, 30189
United States, Kentucky
Bardstown, Kentucky, United States, 40004
Crestview Hills, Kentucky, United States, 41017
Louisville, Kentucky, United States, 40291
United States, Louisiana
Bossier City, Louisiana, United States, 71111
United States, Maryland
Frederick, Maryland, United States, 21702
United States, Nebraska
Bellevue, Nebraska, United States, 68123
Omaha, Nebraska, United States, 68124
Omaha, Nebraska, United States, 68131
Omaha, Nebraska, United States, 68132
United States, New York
Rochester, New York, United States, 14618
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Cleveland, Ohio, United States, 44121
United States, Oregon
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Erie, Pennsylvania, United States, 16505
Norristown, Pennsylvania, United States, 19401
Pittsburgh, Pennsylvania, United States, 15236
Pittsburgh, Pennsylvania, United States, 15241
Rydal, Pennsylvania, United States, 19046
Uniontown, Pennsylvania, United States, 15401
United States, Tennessee
Kingsport, Tennessee, United States, 37660
Tullahoma, Tennessee, United States, 37388
United States, Texas
San Antonio, Texas, United States, 78229
United States, Utah
Layton, Utah, United States, 84041
Springville, Utah, United States, 84663
United States, Virginia
Chesapeake, Virginia, United States, 23321
Midlothian, Virginia, United States, 23113
United States, Washington
Spokane, Washington, United States, 99202
Spokane, Washington, United States, 99218
United States, Wisconsin
LaCrosse, Wisconsin, United States, 54601
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2C8
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Medical Director Sanofi Pasteur Inc
Additional Information:
Layout table for additonal information
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00467519    
Other Study ID Numbers: TD517
First Posted: April 30, 2007    Key Record Dates
Results First Posted: December 3, 2010
Last Update Posted: February 7, 2014
Last Verified: January 2014
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL
Additional relevant MeSH terms:
Layout table for MeSH terms
Whooping Cough
Tetanus
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections