CompletedNCT00467519Updated Feb 7, 2014Results posted

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

A Phase 3 interventional study of Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis) and DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed) in Tetanus, Diphtheria and Pertussis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 43 sites in 2 countries. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-07.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 1,045
Allocation: Randomized
Ages: 4 Years to 6 Years
Sex: All

Study 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 studied

Tetanus
Diphtheria
Pertussis

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Keywords

Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL

In context

Whooping Cough

238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.

This study's enrollment of 1,045 is above the median of 375 across 180 interventional studies indexed under Whooping Cough.

Browse Whooping Cough studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 4 Years to 6 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 1,045 participants (actual)

Study arms

Experimental
Group 1
DAPTACEL primed participants
Biological: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
Experimental
Group 2
Pentacel primed participants
Biological: DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)

Interventions

BiologicalTdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
0.5 mL, IM
Also known as: Adacel
BiologicalDTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
0.5 mL, IM
Also known as: DAPTACEL in the US, TRIPACEL in Canada

What researchers measure

Primary outcomes

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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Pre-dose and 30 Days Post-vaccination

Other outcomes

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.
Time frame: Days 0 to 7 post-vaccination

Results

Posted Dec 3, 2010

Participant flow

Participants were enrolled from 13 April 2007 to 16 October 2009 in 42 clinical centers in the US and 1 clinical center in Canada.

Participant flow — Overall Study
Milestone	Tdap Vaccine Group	DTaP Vaccine Group
Started	531	511
Completed	517	488
Not completed	14	23
Withdrew: Protocol violation	8	4
Withdrew: Lost to follow-up	2	9
Withdrew: Withdrawal by subject	4	10

Outcome measures

PrimaryPercentage 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).

Time frame:: Pre-dose and 30 days post-vaccination
Reported as:: Number · Percentage of Participants

Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level
Percentage of Participants	Tdap Vaccine Group	DTaP Vaccine Group
Diphtheria (IU/mL), Pre-dose [n = 442, 425]	65	69
Diphtheria (IU/mL), Post-dose [n = 442, 426]	100	100
Tetanus (IU/mL), Pre-dose [n = 442, 426]	81	85
Tetanus (IU/mL), Post-dose [n = 442, 426]	100	100

PrimaryPercentage 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).

Time frame:: Pre-dose and 30 days post-vaccination
Reported as:: Number · Percentage of Participants

Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL
Percentage of Participants	Tdap Vaccine Group	DTaP Vaccine Group
Diphtheria (IU/mL), Pre-dose	4	7
Diphtheria (IU/mL), Post-dose	99	100
Tetanus (IU/mL), Pre-dose	11	12
Tetanus (IU/mL), Post-dose	97	98

PrimaryPercentage 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).

Time frame:: 30 Days post-vaccination
Reported as:: Number · Percentage of Participants

Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis
Percentage of Participants	Tdap Vaccine Group	DTaP Vaccine Group
Pertussis Toxoid (EU/mL) [n = 401, 387]	88	94
Filamentous Haemagglutinin (EU/mL) [n = 432, 407]	92	89
Pertactin (EU/mL) [n = 441, 423]	92	95
Fimbriae types 2 and 3 (EU/mL) [n = 432, 418]	95	94

Other pre-specifiedNumber 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.

Time frame:: Days 0 to 7 post-vaccination
Reported as:: Number · Participants

Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Participants	Tdap Vaccine Group	DTaP Vaccine Group
Any Solicited Injection Site Reaction [n=529, 495]	455	451
Any Pain [n = 529, 495]	318	334
Grade 3 Pain (Incapacitating)	1	4
Any Erythema [n = 529, 494]	140	201
Grade 3 Erythema (> 50 mm)	17	65
Any Swelling [n = 529, 493]	100	144
Grade 3 Swelling (> 50 mm)	8	23
Any Increased Left Limb Circumference [n=527, 494]	309	353
Grade 3 Left Limb Circumference (> 40 mm increase)	1	5
Any Increased Right Limb Circumference [n=527, 494	241	244
Grade 3 Right Limb Circumerence (> 40 mm increase)	1	0
Any Solicited System Reaction [n = 529, 495]	256	260
Any Fever [n = 527, 493]	25	26
Grade 3 Fever (> 39.5 °C)	1	1
Any Headache [n = 529, 495]	60	74
Grade 3 Headache (Prevents daily activities)	3	4
Any Malaise [n = 529, 495]	143	150
Grade 3 Malaise (Prevents daily activities)	5	7
Any Myalgia [n = 529, 495]	185	196
Grade 3 Myalgia (Prevents daily activities)	3	8

PrimaryPercentage 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).

Time frame:: 30 Days post-vaccination
Reported as:: Number · Percentage of Participants

Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus
Percentage of Participants	Tdap Vaccine Group	DTaP Vaccine Group
Diphtheria (IU/mL) [n = 442, 425]	99	99
Tetanus (IU/mL) [n = 442, 426]	98	97

PrimaryGeometric 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).

Time frame:: Pre-dose and 30 Days Post-vaccination
Reported as:: Geometric mean · EU/mL

Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
EU/mL	Tdap Vaccine Group	DTaP Vaccine Group
Pertussis Toxoid, Pre-dose [n = 411, 390]	4.58 (4.16 to 5.05)	4.98 (4.49 to 5.51)
Pertussis Toxoid, Post-dose [n = 430, 423]	53.1 (49.3 to 57.2)	86.4 (79.9 to 93.5)
Filamentous Haemagglutinin, Pre-dose [n= 435, 408]	7.56 (6.64 to 8.61)	7.60 (6.59 to 8.76)
Filamentous Haemagglutinin, Post-dose [n=439, 424]	102 (93.1 to 111)	86.5 (78.3 to 95.5)
Pertactin, Pre-dose [n = 442, 424]	9.31 (8.40 to 10.3)	11.1 (10.0 to 12.4)
Pertactin, Post-dose [n = 441, 425]	121 (109 to 134)	173 (155 to 193)
Fimbriae types 2 and 3, Pre-dose [n = 434, 420]	23.8 (21.0 to 27.0)	24.4 (21.4 to 27.7)
Fimbriae types 2 and 3, Post-dose [n = 439, 424]	425 (387 to 467)	388 (354 to 425)

Adverse events

Collected over Adverse event data were collected from the day of vaccination to 6 months post-vaccination.. Non-serious events are listed at a 5.0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Tdap Vaccine Group	—	4/531 (0.8%)	318/531 (59.9%)
DTaP Vaccine Group	—	5/511 (1%)	353/511 (69.1%)

Most frequent serious events

Most frequent serious events
Event	Tdap Vaccine Group	DTaP Vaccine Group
DehydrationMetabolism and nutrition disorders	1/531	3/511
ConstipationGastrointestinal disorders	0/531	1/511
AsthmaRespiratory, thoracic and mediastinal disorders	0/531	1/511
AppendicitisInfections and infestations	1/531	0/511
PneumoniaInfections and infestations	1/531	0/511
PyelonephritisInfections and infestations	1/531	0/511
Status asthmaticusRespiratory, thoracic and mediastinal disorders	1/531	0/511

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	Tdap Vaccine Group	DTaP Vaccine Group
Increased left limb circumferenceGeneral disorders	309/527	353/494
Solicited Injection Site PainGeneral disorders	318/529	334/495
Increased right limb circumferenceGeneral disorders	241/527	244/494
Injection site ErythemaGeneral disorders	140/529	201/494
MyalgiaMusculoskeletal and connective tissue disorders	185/529	196/495
Solicited Injection Site SwellingGeneral disorders	100/529	144/493
HeadacheNervous system disorders	60/529	74/495
CoughRespiratory, thoracic and mediastinal disorders	48/531	29/511
Injection site bruisingGeneral disorders	28/531	40/511
Injection site indurationGeneral disorders	20/531	28/511

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Tdap Vaccine Group	DTaP Vaccine Group	Total
<=18 years	531	511	1042
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Age, Continuous
Age, Continuous(Years)	Tdap Vaccine Group	DTaP Vaccine Group	Total
Mean	4.45 ± 0.48	4.42 ± 0.47	4.44 ± 0.48

Sex: Female, Male
Sex: Female, Male(Participants)	Tdap Vaccine Group	DTaP Vaccine Group	Total
Female	275	244	519
Male	256	267	523

Region of Enrollment
Region of Enrollment(participants)	Tdap Vaccine Group	DTaP Vaccine Group	Total
United States	522	502	1024
Canada	9	9	18

Study locations

43 sites

Birmingham, Alabama 35205, United States
Birmingham, Alabama 35244, United States
Fayetteville, Arkansas 72703, United States
Jonesboro, Arkansas 72401, United States
Little Rock, Arkansas 72205, United States
Fountain Valley, California 92708, United States
Huntington Beach, California 92647, United States
Oakland, California 94611, United States
Roseville, California 95661, United States
Sacramento, California 95815, United States
Norwich, Connecticut 06360, United States
Marietta, Georgia 30062, United States
Woodstock, Georgia 30189, United States
Bardstown, Kentucky 40004, United States
Crestview Hills, Kentucky 41017, United States
Louisville, Kentucky 40291, United States
Bossier City, Louisiana 71111, United States
Frederick, Maryland 21702, United States
Bellevue, Nebraska 68123, United States
Omaha, Nebraska 68124, United States
Omaha, Nebraska 68131, United States
Omaha, Nebraska 68132, United States
Rochester, New York 14618, United States
Fargo, North Dakota 58103, United States
Cleveland, Ohio 44121, United States
Gresham, Oregon 97030, United States
Erie, Pennsylvania 16505, United States
Norristown, Pennsylvania 19401, United States
Pittsburgh, Pennsylvania 15236, United States
Pittsburgh, Pennsylvania 15241, United States
Rydal, Pennsylvania 19046, United States
Uniontown, Pennsylvania 15401, United States
Kingsport, Tennessee 37660, United States
Tullahoma, Tennessee 37388, United States
San Antonio, Texas 78229, United States
Layton, Utah 84041, United States
Springville, Utah 84663, United States
Chesapeake, Virginia 23321, United States
Midlothian, Virginia 23113, United States
Spokane, Washington 99202, United States
Spokane, Washington 99218, United States
LaCrosse, Wisconsin 54601, United States
Edmonton, Alberta T6G 2C8, Canada

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00467519
Lead sponsor: Sanofi Pasteur, a Sanofi Company
Responsible party: Sponsor
First posted: Apr 30, 2007
Start date: Apr 2007
Primary completion: Nov 2009
Completion: Dec 2009
Results posted: Dec 3, 2010
Last update: Feb 7, 2014

Study contacts

Medical Director

study director · Sanofi Pasteur Inc

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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