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Trial record 1 of 1 for:    TD517
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Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age

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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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Tetanus
Diphtheria
Pertussis
Interventions Biological: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
Biological: DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
Enrollment 1045
Recruitment Details Participants were enrolled from 13 April 2007 to 16 October 2009 in 42 clinical centers in the US and 1 clinical center in Canada.
Pre-assignment Details A total of 1042 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Tdap Vaccine Group DTaP Vaccine Group
Hide Arm/Group Description Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap). Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
Period Title: Overall Study
Started 531 511
Completed 517 488
Not Completed 14 23
Reason Not Completed
Protocol Violation             8             4
Lost to Follow-up             2             9
Withdrawal by Subject             4             10
Arm/Group Title Tdap Vaccine Group DTaP Vaccine Group Total
Hide Arm/Group Description Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap). Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP). Total of all reporting groups
Overall Number of Baseline Participants 531 511 1042
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 531 participants 511 participants 1042 participants
<=18 years
531
 100.0%
511
 100.0%
1042
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 531 participants 511 participants 1042 participants
4.45  (0.48) 4.42  (0.47) 4.44  (0.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 531 participants 511 participants 1042 participants
Female
275
  51.8%
244
  47.7%
519
  49.8%
Male
256
  48.2%
267
  52.3%
523
  50.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 531 participants 511 participants 1042 participants
United States 522 502 1024
Canada 9 9 18
1.Primary Outcome
Title Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.
Arm/Group Title Tdap Vaccine Group DTaP Vaccine Group
Hide Arm/Group Description:
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
Overall Number of Participants Analyzed 442 426
Measure Type: Number
Unit of Measure: Percentage of Participants
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
2.Primary Outcome
Title Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.
Arm/Group Title Tdap Vaccine Group DTaP Vaccine Group
Hide Arm/Group Description:
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
Overall Number of Participants Analyzed 442 426
Measure Type: Number
Unit of Measure: Percentage of Participants
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
3.Primary Outcome
Title Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Pertussis antibody booster response analysis was in all enrolled and vaccinated participants in the per-protocol population.
Arm/Group Title Tdap Vaccine Group DTaP Vaccine Group
Hide Arm/Group Description:
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
Overall Number of Participants Analyzed 441 423
Measure Type: Number
Unit of Measure: Percentage of Participants
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
4.Primary Outcome
Title Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Diphtheria and tetanus antibody booster response were analysed in all enrolled and vaccinated participants, per-protocol population.
Arm/Group Title Tdap Vaccine Group DTaP Vaccine Group
Hide Arm/Group Description:
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
Overall Number of Participants Analyzed 442 426
Measure Type: Number
Unit of Measure: Percentage of Participants
Diphtheria (IU/mL) [n = 442, 425] 99 99
Tetanus (IU/mL) [n = 442, 426] 98 97
5.Primary Outcome
Title Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the per-protocol population.
Arm/Group Title Tdap Vaccine Group DTaP Vaccine Group
Hide Arm/Group Description:
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
Overall Number of Participants Analyzed 442 426
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
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)
6.Other Pre-specified Outcome
Title Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Arm/Group Title Tdap Vaccine Group DTaP Vaccine Group
Hide Arm/Group Description:
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
Overall Number of Participants Analyzed 531 511
Measure Type: Number
Unit of Measure: Participants
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
Time Frame Adverse event data were collected from the day of vaccination to 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tdap Vaccine Group DTaP Vaccine Group
Hide Arm/Group Description Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap). Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
All-Cause Mortality
Tdap Vaccine Group DTaP Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tdap Vaccine Group DTaP Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/531 (0.75%)      5/511 (0.98%)    
Gastrointestinal disorders     
Constipation * 1  0/531 (0.00%)  0 1/511 (0.20%)  1
Infections and infestations     
Appendicitis * 1  1/531 (0.19%)  1 0/511 (0.00%)  0
Pneumonia * 1  1/531 (0.19%)  1 0/511 (0.00%)  0
Pyelonephritis * 1  1/531 (0.19%)  1 0/511 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/531 (0.19%)  1 3/511 (0.59%)  3
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  0/531 (0.00%)  0 1/511 (0.20%)  1
Status asthmaticus * 1  1/531 (0.19%)  1 0/511 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Tdap Vaccine Group DTaP Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   318/531 (59.89%)      353/511 (69.08%)    
General disorders     
Injection site Erythema  1  140/529 (26.47%)  140 201/494 (40.69%)  201
Fever  1  25/527 (4.74%)  25 26/493 (5.27%)  26
Increased left limb circumference  1  309/527 (58.63%)  309 353/494 (71.46%)  353
Increased right limb circumference  1  241/527 (45.73%)  241 244/494 (49.39%)  244
Injection site bruising * 1  28/531 (5.27%)  31 40/511 (7.83%)  42
Injection site induration * 1  20/531 (3.77%)  21 28/511 (5.48%)  30
Solicited Injection Site Pain  1  318/529 (60.11%)  318 334/495 (67.47%)  334
Solicited Injection Site Swelling  1  100/529 (18.90%)  100 144/493 (29.21%)  144
Musculoskeletal and connective tissue disorders     
Myalgia  1  185/529 (34.97%)  185 196/495 (39.60%)  196
Nervous system disorders     
Headache  1  60/529 (11.34%)  60 74/495 (14.95%)  74
Respiratory, thoracic and mediastinal disorders     
Cough * 1  48/531 (9.04%)  49 29/511 (5.68%)  31
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00467519     History of Changes
Other Study ID Numbers: TD517
First Submitted: April 27, 2007
First Posted: April 30, 2007
Results First Submitted: November 4, 2010
Results First Posted: December 3, 2010
Last Update Posted: February 7, 2014