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Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose

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ClinicalTrials.gov Identifier: NCT00712959
Recruitment Status : Completed
First Posted : July 10, 2008
Results First Posted : April 30, 2014
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Pertussis
Tetanus
Diphtheria
Intervention Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
Enrollment 769
Recruitment Details Participants were enrolled from 26 June 2008 to 27 February 2009 at 7 medical centers in Canada.
Pre-assignment Details A total of 769 participants who met the inclusion and exclusion criteria were enrolled, 768 were vaccinated and evaluated.
Arm/Group Title Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve
Hide Arm/Group Description Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805) Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
Period Title: Overall Study
Started 361 407
Completed 342 404
Not Completed 19 3
Reason Not Completed
Protocol Violation             3             1
Lost to Follow-up             13             2
Withdrawal by Subject             3             0
Arm/Group Title Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve Total
Hide Arm/Group Description Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805) Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose. Total of all reporting groups
Overall Number of Baseline Participants 361 407 768
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 361 participants 407 participants 768 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
356
  98.6%
402
  98.8%
758
  98.7%
>=65 years
5
   1.4%
5
   1.2%
10
   1.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 361 participants 407 participants 768 participants
31.2  (14.0) 34.6  (12.5) 33.0  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 361 participants 407 participants 768 participants
Female
194
  53.7%
264
  64.9%
458
  59.6%
Male
167
  46.3%
143
  35.1%
310
  40.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 361 participants 407 participants 768 participants
361 407 768
1.Primary Outcome
Title Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose
Hide Description

Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA).

Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL.

Time Frame Day 0 (pre-vaccination) and 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.
Arm/Group Title Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve
Hide Arm/Group Description:
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
Overall Number of Participants Analyzed 324 381
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-tetanus Pre-vaccination 45 49
Anti-tetanus Post-vaccination 100 100
Anti-Diphtheria Pre-vaccination 74 66
Anti-Diphtheria Post-vaccination 99 96
2.Primary Outcome
Title Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose
Hide Description Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean concentrations were assessed in the per-protocol population.
Arm/Group Title Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve
Hide Arm/Group Description:
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
Overall Number of Participants Analyzed 324 381
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Pertussis Toxoid [n=318, 357]
116
(105 to 129)
89.2
(80.2 to 99.3)
Filamentous Haemagglutinin [n=324, 380]
214
(199 to 231)
249
(229 to 272)
Pertactin [n=324, 381]
266
(243 to 292)
216
(188 to 247)
Fimbriae Types 2 and 3 [n=324, 378]
779
(720 to 843)
1015
(894 to 1154)
3.Other Pre-specified Outcome
Title Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose
Hide Description

Anti-diphtheria or anti-tetanus booster responses were defined as:

Pre-vaccination antibody concentrations of < 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to < 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response.

Time Frame Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Booster Response to Tetanus and Diptheria antigens were assessed in the per-protocol population.
Arm/Group Title Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve
Hide Arm/Group Description:
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
Overall Number of Participants Analyzed 324 381
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-Tetanus [N = 324, 379] 83 82
Anti-Diphtheria [N = 324, 381] 86 81
4.Other Pre-specified Outcome
Title Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose
Hide Description

Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration:

  • ≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was < LLOQ; or
  • ≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but < 4 x LLOQ; or
  • ≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ.
Time Frame Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Booster response for each anti-Pertussis antibody was assessed in the per-protocol population.
Arm/Group Title Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve
Hide Arm/Group Description:
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
Overall Number of Participants Analyzed 324 381
Measure Type: Number
Unit of Measure: Percentage of Particpants
Anti-Pertussis Toxoid [N = 285, 330] 88 84
Filamentous Haemagglutinin [N = 324, 379] 88 94
Pertactin [N = 324, 381] 90 93
Fimbriae Types 2 and 3 [N = 324, 371] 84 93
5.Other Pre-specified Outcome
Title Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Hide Description Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame Day 0 (pre-vaccination) and Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean concentrations were assessed in the per-protocol population.
Arm/Group Title Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve
Hide Arm/Group Description:
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
Overall Number of Participants Analyzed 324 381
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Pertussis Toxoid [Pre, N = 291, 353]
15.1
(12.9 to 17.6)
9.42
(8.20 to 10.8)
Pertussis Toxoid [Post, N = 318, 357]
116
(105 to 129)
89.2
(80.2 to 99.3)
Filamentous Haemagglutinin [Pre, N = 324, 380]
34.8
(31.2 to 38.7)
20.0
(17.7 to 22.5)
Filamentous Haemagglutinin [Post, N = 324, 380]
214
(199 to 231)
249
(229 to 272)
Pertactin [Pre, N = 324, 381]
28.2
(24.4 to 32.7)
8.54
(7.41 to 9.85)
Pertactin [Post, N = 324, 381]
266
(243 to 292)
216
(188 to 247)
Fimbriae Types 2 and 3 [Pre, N = 324, 374]
124
(111 to 139)
37.8
(32.7 to 43.7)
Fimbriae Types 2 and 3 [Post, N=324, 378]
779
(720 to 843)
1015
(894 to 1154)
6.Other Pre-specified Outcome
Title Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Hide Description Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame Day 0 (pre-vaccination) and Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean concentrations were assessed in the per-protocol population.
Arm/Group Title Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve
Hide Arm/Group Description:
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
Overall Number of Participants Analyzed 324 381
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-Tetanus [Pre, N = 324, 379]
0.835
(0.754 to 0.924)
0.778
(0.679 to 0.892)
Anti-Tetanus [Post, N = 324, 381]
8.79
(8.06 to 9.59)
9.64
(8.73 to 10.7)
Anti-Diphtheria [Pre, N = 324, 381]
0.283
(0.235 to 0.341)
0.198
(0.163 to 0.240)
Anti-Diphtheria [Post, N = 324, 381]
4.06
(3.49 to 4.71)
2.74
(2.36 to 3.18)
7.Other Pre-specified Outcome
Title Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Hide Description

Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia.

Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: > 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities.

Time Frame Day 0 up to Day 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 Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve
Hide Arm/Group Description:
Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
Overall Number of Participants Analyzed 361 407
Measure Type: Number
Unit of Measure: Participants
Any Pain [N = 352, 404] 309 341
Grade 3 Pain [N = 352, 404] 9 7
Any Erythema [N = 351, 404] 81 120
Grade 3 Erythema [N = 351, 404] 7 7
Any Swelling [N= 352, 403] 72 94
Grade 3 Swelling [N= 352, 403] 9 7
Any Fever [N = 356, 405] 15 20
Grade 3 Fever [N = 356, 405] 0 0
Any Headache [N = 350, 404] 142 152
Grade 3 Headache [N = 350, 404] 6 8
Any Malaise [N = 350, 404] 103 117
Grade 3 Malaise [N = 350, 404] 7 8
Any Myalgia [N = 351, 404] 211 216
Grade 3 Myalgia [N = 351, 404] 8 6
Time Frame Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination
Adverse Event Reporting Description The diary cards for solicited safety data were not returned for some participants; the total number for each event therefore represents those with available data for the indicated event.
 
Arm/Group Title Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve
Hide Arm/Group Description Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805) Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
All-Cause Mortality
Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/361 (0.83%)      1/407 (0.25%)    
Congenital, familial and genetic disorders     
Arnold-Chiari Malformation * 1  1/361 (0.28%)  1 0/407 (0.00%)  0
General disorders     
Death * 1  0/361 (0.00%)  0 1/407 (0.25%)  1
Injury, poisoning and procedural complications     
Animal Bite * 1  1/361 (0.28%)  1 0/407 (0.00%)  0
Reproductive system and breast disorders     
Vaginal Haematoma * 1  1/361 (0.28%)  1 0/407 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Group 1: Previous Tdap or Tdap-IPV Recipients Group 2: Tdap Vaccine-naïve
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   309/361 (85.60%)      341/407 (83.78%)    
General disorders     
Solicited Injection Site Pain  1  309/352 (87.78%)  309 341/404 (84.41%)  341
Solicited Injection Site Erythema  1  81/351 (23.08%)  81 120/404 (29.70%)  120
Malaise  1  103/350 (29.43%)  103 117/404 (28.96%)  117
Solicited Injection Site Swelling * 1  72/351 (20.51%)  72 94/403 (23.33%)  94
Infections and infestations     
Nasopharyngitis * 1  30/361 (8.31%)  31 23/407 (5.65%)  23
Musculoskeletal and connective tissue disorders     
Myalgia  1  211/351 (60.11%)  211 216/404 (53.47%)  216
Nervous system disorders     
Headache  1  142/350 (40.57%)  142 152/404 (37.62%)  152
Headache * 1  13/361 (3.60%)  13 36/407 (8.85%)  36
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal Pain * 1  14/361 (3.88%)  14 22/407 (5.41%)  23
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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: NCT00712959     History of Changes
Other Study ID Numbers: TD526
First Submitted: July 7, 2008
First Posted: July 10, 2008
Results First Submitted: February 18, 2014
Results First Posted: April 30, 2014
Last Update Posted: April 30, 2014