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Trial record 1 of 1 for:    TD518
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Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine

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ClinicalTrials.gov Identifier: NCT00347958
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : July 22, 2010
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Tetanus
Diphtheria
Pertussis
Intervention Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
Enrollment 545
Recruitment Details Participants were enrolled from 21 August 2006, to 12 April 2007, in 6 clinical centers in the US and 6 clinical centers in Canada.
Pre-assignment Details A total of 545 participants were enrolled and vaccinated in the study. Data on 544 participants that met the inclusion and exclusion criteria were analyzed and reported. One participant who did not receive Adacel® vaccine in one of the previous studies was excluded from the Safety Analysis Set.
Arm/Group Title Adacel® Vaccine Group
Hide Arm/Group Description Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
Period Title: Overall Study
Started 544
Completed 540
Not Completed 4
Reason Not Completed
Adverse Event             1
Protocol Violation             2
Withdrawal by Subject             1
Arm/Group Title Adacel® Vaccine Group
Hide Arm/Group Description Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
Overall Number of Baseline Participants 544
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 544 participants
<=18 years
169
  31.1%
Between 18 and 65 years
368
  67.6%
>=65 years
7
   1.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 544 participants
31.7  (15.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 544 participants
Female
284
  52.2%
Male
260
  47.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 544 participants
United States 194
Canada 350
1.Primary Outcome
Title Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Hide Description Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.
Time Frame 0-14 days 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.

The solicited systemic reaction, malaise was not collected in the previous studies.

Arm/Group Title Adacel® Vaccine Group
Hide Arm/Group Description:
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
Overall Number of Participants Analyzed 544
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Injection Site Reaction 89
Any Injection Site Pain 88
Grade 3 Injection Site Pain (Incapacitating) 2
Any Injection Site Erythema/Redness 29
Grade 3 Injection Site Erythema/Redness (≥ 5 cm) 3
Any Injection Site Swelling 26
Grade 3 Injection Site Swelling (≥ 5 cm) 3
Any Fever 7
Grade 3 Fever (> 39.0 ºC or > 102.2 ºF) 1
Any Headache 53
Grade 3 Headache (Prevents daily activities) 3
Any Myalgia 61
Grade 3 Myalgia (Prevents daily activities) 4
Any Malaise 38
Grade 3 Malaise (Prevents daily activities) 3
2.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.
Hide Description Pre- and post-vaccination GMTs and their 95% confidence intervals for diphtheria were determined by toxin neutralization testing; the other antibody levels were determined by enzyme-linked immunosorbent assay testing.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the per-protocol population.
Arm/Group Title Adacel® Vaccine Group
Hide Arm/Group Description:
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
Overall Number of Participants Analyzed 451
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Tetanus (IU/mL) Pre-Dose, n = 445
1.41
(1.27 to 1.56)
Tetanus (IU/mL) Post-Dose, n = 445
9.62
(9.06 to 10.2)
Diphtheria (IU/mL) no Menactra Pre-Dose, n = 379
0.133
(0.110 to 0.162)
Diphtheria (IU/mL) no Menactra Post-Dose n = 379
2.17
(1.84 to 2.56)
Diphtheria (IU/mL) with Menactra Pre-Dose n = 64
4.45
(2.77 to 7.15)
Diphtheria (IU/mL) with Menactra Post-Dose n = 64
8.70
(6.59 to 11.5)
3.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.
Hide Description Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the per-protocol population.
Arm/Group Title Adacel® Vaccine Group
Hide Arm/Group Description:
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
Overall Number of Participants Analyzed 451
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Pertussis PT (EU/mL) Pre-Dose, n = 381
21.3
(19.4 to 23.5)
Pertussis PT (EU/mL) Post-Dose, n = 425
104
(97.0 to 112)
Pertussis FHA (EU/mL) Pre-Dose, n = 450
34.6
(31.9 to 37.5)
Pertussis FHA (EU/mL) Post-Dose, n = 450
201
(189 to 215)
Pertussis PRN (EU/mL) Pre-Dose, n = 451
37.3
(32.7 to 42.6)
Pertussis PRN (EU/mL) Post-Dose, n = 451
218
(201 to 236)
Pertussis FIM (EU/mL) Pre-Dose, n = 445
165
(145 to 187)
Pertussis FIM (EU/mL) Post-Dose, n = 450
749
(697 to 806)
4.Other Pre-specified Outcome
Title Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®
Hide Description Seroprotection: Tetanus or diphtheria titer ≥ 0.1 after Adacel® vaccination. Tetanus titers determined by enzyme-linked immunosorbent assay; diphtheria titers determined by toxin neutralization assay.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Tetanus and diphtheria antibody analyses were in all enrolled and vaccinated participants in the per-protocol population. Diphtheria antibody titers were analyzed separately for participants without and with an intervening Menactra vaccination between the previous study and Study Td518.
Arm/Group Title Adacel® Vaccine Group
Hide Arm/Group Description:
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
Overall Number of Participants Analyzed 451
Measure Type: Number
Unit of Measure: Percentage of Participants
Tetanus (IU/mL) Pre-Dose 96
Tetanus (IU/mL) Post-Dose 100
Diphtheria (IU/mL) without Menactra, Pre-Dose 61
Diphtheria (IU/mL) without Menactra, Post-Dose 95
Diphtheria (IU/mL) Menactra, Pre-Dose 95
Diphtheria (IU/mL) Menactra, Post-Dose 100
Time Frame Adverse events data were collected from the day of vaccination to 6 months post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adacel® Vaccine Group
Hide Arm/Group Description Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
All-Cause Mortality
Adacel® Vaccine Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adacel® Vaccine Group
Affected / at Risk (%) # Events
Total   7/544 (1.29%)    
Cardiac disorders   
Cardiac arrest * 1  1/544 (0.18%)  1
Infections and infestations   
Appendicitis * 1  0/544 (0.00%)  0
Cellulitis * 1  1/544 (0.18%)  1
Kidney infection * 1  0/544 (0.00%)  0
Injury, poisoning and procedural complications   
Intentional overdose * 1  1/544 (0.18%)  1
Metabolism and nutrition disorders   
Pyelonephritis * 1  1/544 (0.18%)  1
Malnutrition * 1  1/544 (0.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Carcinoid tumour of the appendix * 1  1/544 (0.18%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/544 (0.18%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Adacel® Vaccine Group
Affected / at Risk (%) # Events
Total   479/544 (88.05%)    
General disorders   
Injection site pain  1  472/539 (87.57%)  472
Injection site erythema/redness  1  154/539 (28.57%)  154
Injection site swelling  1  138/539 (25.60%)  138
Pyrexia (Fever)  1  35/538 (6.51%)  35
Malaise * 1  206/539 (38.22%)  206
Infections and infestations   
Nasopharyngitis * 1  44/544 (8.09%)  45
Musculoskeletal and connective tissue disorders   
Myalgia  1  329/539 (61.04%)  329
Nervous system disorders   
Headache  1  287/539 (53.25%)  287
Respiratory, thoracic and mediastinal disorders   
Pharyngolaryngeal pain * 1  35/544 (6.43%)  40
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
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: NCT00347958     History of Changes
Other Study ID Numbers: TD518
First Submitted: July 3, 2006
First Posted: July 4, 2006
Results First Submitted: May 14, 2010
Results First Posted: July 22, 2010
Last Update Posted: December 4, 2013