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Trial record 1 of 1 for:    TD516
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Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®

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ClinicalTrials.gov Identifier: NCT00319553
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : October 21, 2010
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Pertussis
Tetanus
Diphtheria
Interventions Biological: ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Biological: BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Enrollment 647
Recruitment Details Participants were enrolled from 09 May 2006 to 02 October 2006 in 12 clinical centers in the US.
Pre-assignment Details A total of 647 participants who met the inclusion and exclusion criteria were enrolled, 644 were vaccinated and included in the analysis.
Arm/Group Title Adacel® Vaccine Group Boostrix® Vaccine Group
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 323 321
Completed 319 317
Not Completed 4 4
Reason Not Completed
Protocol Violation             1             2
Lost to Follow-up             2             1
Withdrawal by Subject             1             1
Arm/Group Title Adacel® Vaccine Group Boostrix® Vaccine Group Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 323 321 644
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 323 participants 321 participants 644 participants
<=18 years
291
  90.1%
291
  90.7%
582
  90.4%
Between 18 and 65 years
32
   9.9%
30
   9.3%
62
   9.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 323 participants 321 participants 644 participants
14.5  (2.33) 14.7  (2.33) 14.6  (2.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 323 participants 321 participants 644 participants
Female
154
  47.7%
150
  46.7%
304
  47.2%
Male
169
  52.3%
171
  53.3%
340
  52.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 323 participants 321 participants 644 participants
323 321 644
1.Primary Outcome
Title Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®
Hide Description

Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.

Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities.

Time Frame Day 0 to 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and Systemic reactions were analyzed in the intent-to-treat safety population
Arm/Group Title Adacel® Vaccine Group Boostrix® Vaccine Group
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 320 317
Measure Type: Number
Unit of Measure: Participants
Any solicited injection site reaction 273 257
Grade 3 solicited injection site reaction 5 4
Any solicited injection site Pain 270 247
Grade 3 solicited inj. site Pain (Incapacitating) 2 3
Any solicited injection site Erythema 75 67
Grade 3 solicited injection site Erythema (≥ 5 cm) 2 1
Any solicited injection site Swelling 61 44
Grade 3 solicited injection site Swelling (≥ 5 cm) 2 1
Any solicited systemic reaction 216 205
Grade 3 solicited systemic reaction 9 9
Any solicited Fever 18 9
Grade 3 solicited Fever (≥ 39.1°C or ≥ 102.3°F) 1 0
Any solicited Headache 136 108
Gr 3 solicited Headache: Prevents daily activities 3 4
Any solicited Malaise 91 78
Gr 3 solicited Malaise: Prevents daily activities 8 6
Any solicited Myalgia 167 166
Gr 3 solicited Myalgia: Prevents daily activities 1 3
2.Primary Outcome
Title Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Hide Description [Not Specified]
Time Frame Day 0 and 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Tetanus antitoxin concentrations were analyzed in the per-protocol population.
Arm/Group Title Adacel® Vaccine Group Boostrix® Vaccine Group
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 305 304
Measure Type: Number
Unit of Measure: Percentage of Participants
Tetanus IgG antitoxin ≥0.1 IU/mL :pre-vaccination 99 98
Tetanus IgG antitoxin ≥0.1 IU/mL :28 days post-vac 100 100
3.Primary Outcome
Title Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Hide Description [Not Specified]
Time Frame Day 0 and 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Diphtheria antitoxin concentrations were analyzed in the per-protocol population
Arm/Group Title Adacel® Vaccine Group Boostrix® Vaccine Group
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 305 304
Measure Type: Number
Unit of Measure: Percentage of Participants
Diphtheria IgG antitoxin ≥0.1 IU/mL : pre-vacc 92 93
Diphtheria IgG antitoxin ≥0.1 IU/mL: 28 D post-vac 100 100
4.Primary Outcome
Title Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.
Hide Description [Not Specified]
Time Frame Day 0 and 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean concentration of antibody to the pertussis antigens were analyzed in the per-protocol population
Arm/Group Title Adacel® Vaccine Group Boostrix® Vaccine Group
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 305 304
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Anti-pertussis toxoid IgG: pre-vaccination
14.4
(12.5 to 16.6)
13.5
(11.6 to 15.8)
Anti-filamentous hemagglutinin IgG:pre-vaccination
26.1
(22.7 to 30.0)
28.2
(24.5 to 32.4)
Anti-pertactin IgG: pre-vaccination
12.4
(10.6 to 14.6)
13.1
(11.2 to 15.5)
Anti-fimbriae types 2 and 3 IgG: pre-vaccination
13.9
(12.0 to 16.2)
14.5
(12.2 to 17.2)
Anti-pertussis toxoid IgG: post-vaccination
86.7
(78.8 to 95.4)
135.9
(122.9 to 150.2)
Anti-filamentous hemagglutinin IgG post-vaccinat.
240.7
(217.7 to 266.1)
402.9
(365.5 to 444.2)
Anti-pertactin IgG: post-vaccination
322.7
(279.7 to 372.4)
463.3
(395.4 to 542.9)
Anti-fimbriae types 2 and 3 IgG: post-vaccination
1203
(1004 to 1442)
26.6
(22.2 to 31.8)
Time Frame Adverse events data were collected from the day of vaccination up to 1 month post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adacel® Vaccine Group Boostrix® Vaccine Group
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Adacel® Vaccine Group Boostrix® Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adacel® Vaccine Group Boostrix® Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/323 (0.00%)   0/321 (0.00%) 
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 Boostrix® Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   273/320 (85.31%)   257/317 (81.07%) 
General disorders     
Solicited injection site Pain  1  270/320 (84.38%)  257/317 (81.07%) 
Solicited injection site Erythema  1  75/320 (23.44%)  67/316 (21.20%) 
Solicited injection site Swelling  1  61/320 (19.06%)  44/316 (13.92%) 
Solicited Fever  1  18/320 (5.63%)  9/316 (2.85%) 
Solicited Malaise  1  91/320 (28.44%)  78/317 (24.61%) 
Musculoskeletal and connective tissue disorders     
Solicited Myalgia  1  167/320 (52.19%)  166/317 (52.37%) 
Nervous system disorders     
Solicited Headache  1  136/320 (42.50%)  108/317 (34.07%) 
Indicates events were collected by 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
ClinicalTrials.gov Identifier: NCT00319553     History of Changes
Other Study ID Numbers: Td516
First Submitted: April 28, 2006
First Posted: April 27, 2006
Results First Submitted: September 28, 2010
Results First Posted: October 21, 2010
Last Update Posted: October 5, 2012