Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Td540
Previous Study | Return to List | Next Study

Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01689324
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : February 21, 2014
Last Update Posted : February 21, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Pertussis
Tetanus
Diphtheria
Intervention Biological: (ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis
Enrollment 43
Recruitment Details The study participants were enrolled from 12 September through 14 October 2012 in 3 clinic centers in Japan.
Pre-assignment Details A total of 43 participants that met all the inclusion criteria but none of the exclusion criteria were enrolled and vaccinated in the study.
Arm/Group Title Study Group
Hide Arm/Group Description Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Period Title: Overall Study
Started 43
Completed 43
Not Completed 0
Arm/Group Title Study Group
Hide Arm/Group Description Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
<=18 years
43
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants
11.4  (0.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
23
  53.5%
Male
20
  46.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 43 participants
43
1.Primary Outcome
Title Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
Hide Description Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: Percentage of Participants
Diphtheria 100
Tetanus 100
2.Primary Outcome
Title Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
Hide Description

Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL.

Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL.

Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Booster response to diphtheria and tetanus antigens were determined in the Immunology Analysis Set
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: Percentage of Participants
Diphtheria 98
Tetanus 100
3.Primary Outcome
Title Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®
Hide Description Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Booster response to pertussis antigens were determined in the Immunology Analysis Set
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: Percentage of Participants
Pertussis toxoid 63
Filamentous hemagglutinin 88
4.Other Pre-specified Outcome
Title Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®
Hide Description Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.
Time Frame Day 0 pre-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: Percentage of Participants
Diphtheria 63
Tetanus 91
5.Other Pre-specified Outcome
Title Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®
Hide Description Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.
Time Frame Day 0 (pre-vaccination) and day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set.
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: Percentage of Participants
Diphtheria (Pre-vaccination) 100
Diphtheria (Post-vaccination) 100
Tetanus (Pre-vaccination) 100
Tetanus (Post-vaccination) 100
6.Other Pre-specified Outcome
Title Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®
Hide Description Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.
Time Frame Day 0 (pre-vaccination) and day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: Percentage of Participants
Diphtheria (Pre-vaccination) 12
Diphtheria (Post-vaccination) 100
Tetanus (Pre-vaccination) 30
Tetanus (Post-vaccination) 100
7.Other Pre-specified Outcome
Title Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL®
Hide Description [Not Specified]
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre and post vaccination geometric mean concentrations to Diphtheria and Tetanus antigens were determined in the Immunology Analysis Set
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Overall Number of Participants Analyzed 43
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Diphtheria (Pre-vaccination)
0.22
(0.14 to 0.35)
Diphtheria (Post-vaccination)
8.58
(6.76 to 10.88)
Tetanus (Pre-vaccination)
0.46
(0.33 to 0.64)
Tetanus (Post-vaccination)
37.80
(30.16 to 47.38)
8.Other Pre-specified Outcome
Title Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®
Hide Description [Not Specified]
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre and post vaccination geometric mean concentrations to pertussis antibodies were determined in the Immunology Analysis Set
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Overall Number of Participants Analyzed 43
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Pertussis toxoid (pre-vaccination)
12.21
(7.82 to 19.05)
Pertussis toxoid (post-vaccination)
46.92
(33.65 to 65.42)
Filamentous hemagglutinin (pre-vaccination)
34.79
(23.47 to 51.57)
Filamentous hemagglutinin (post-vaccination)
204.00
(164.26 to 253.36)
Pertactin (pre-vaccination)
10.64
(6.28 to 18.03)
Pertactin (post-vaccination)
272.82
(197.63 to 376.62)
Fimbriae types 2 and 3 (pre-vaccination)
7.78
(5.42 to 11.17)
Fimbriae types 2 and 3 (post-vaccination)
748.28
(443.23 to 1263.27)
9.Other Pre-specified Outcome
Title Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL®
Hide Description Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Booster response to pertussis antigens were determined in the Immunology Analysis Set
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: Percentage of Participants
Pertactin 93
Fimbriae Types 2 and 3 98
10.Other Pre-specified Outcome
Title Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL®
Hide Description

Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, >100 mm.

Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity.

Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in the Safety Analysis Set
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: Participants
Solicited injection site Pain 37
Grade 3 solicited injection site Pain 0
Solicited injection site Erythema 9
Grade 3 solicited injection site Erythema 0
Solicited injection site Swelling 12
Grade 3 solicited injection site Swelling 1
Fever 9
Grade 3 Fever 1
Headache 8
Grade 3 Headache 0
Malaise 11
Grade 3 Malaise 0
Myalgia 17
Grade 3 Myalgia 0
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to 1 month post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group
Hide Arm/Group Description Participants received a single booster dose of Tdap vaccine on Day 0.
All-Cause Mortality
Study Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Group
Affected / at Risk (%) # Events
Total   0/43 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Study Group
Affected / at Risk (%) # Events
Total   39/43 (90.70%)    
General disorders   
Solicited injection site Pain  1  37/43 (86.05%)  37
Solicited injection site Erythema  1  9/43 (20.93%)  9
Solicited injection site Swelling  1  12/43 (27.91%)  12
Fever  1  9/43 (20.93%)  9
Malaise  1  11/43 (25.58%)  11
Myalgia  1  17/43 (39.53%)  17
Infections and infestations   
Nasopharyngitis * 1  7/43 (16.28%)  9
Nervous system disorders   
Headache * 1  8/43 (18.60%)  8
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
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: NCT01689324     History of Changes
Other Study ID Numbers: Td540
U1111-1124-7671 ( Other Identifier: WHO )
First Submitted: September 17, 2012
First Posted: September 21, 2012
Results First Submitted: November 7, 2013
Results First Posted: February 21, 2014
Last Update Posted: February 21, 2014