Back to resultsSafety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
Primary Purpose
Tetanus, Diphtheria, Pertussis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
Sponsored by
About this trial
This is an interventional prevention trial for Tetanus focused on measuring Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
DAPTACEL primed participants
Pentacel primed participants
Outcomes
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
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
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
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
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
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00467519
First Posted
April 27, 2007
Last Updated
January 10, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00467519
Brief Title
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
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 Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus, Diphtheria, Pertussis
Keywords
Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1045 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
DAPTACEL primed participants
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Pentacel primed participants
Intervention Type
Biological
Intervention Name(s)
Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
Other Intervention Name(s)
Adacel
Intervention Description
0.5 mL, IM
Intervention Type
Biological
Intervention Name(s)
DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
Other Intervention Name(s)
DAPTACEL in the US, TRIPACEL in Canada
Intervention Description
0.5 mL, IM
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level
Description
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).
Time Frame
Pre-dose and 30 days post-vaccination
Title
Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL
Description
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).
Time Frame
Pre-dose and 30 days post-vaccination
Title
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis
Description
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).
Time Frame
30 Days post-vaccination
Title
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus
Description
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).
Time Frame
30 Days post-vaccination
Title
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Description
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).
Time Frame
Pre-dose and 30 Days Post-vaccination
Other Pre-specified Outcome Measures:
Title
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Description
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.
Time Frame
Days 0 to 7 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68132
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
City
Rydal
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23113
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
City
LaCrosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
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