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Trial record 1 of 1 for:    TD521
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Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

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ClinicalTrials.gov Identifier: NCT00258908
Recruitment Status : Completed
First Posted : November 28, 2005
Results First Posted : June 8, 2009
Last Update Posted : April 14, 2016
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 Diphtheria
Tetanus
Pertussis
Intervention Biological: Diphteria, tetanus, and Acellular Pertussis vaccine
Enrollment 115
Recruitment Details Study participants were enrolled from 01 November through 07 December 2005 in 1 medical clinic in Taiwan
Pre-assignment Details A total of 115 participants that met the inclusion and exclusion criteria were recruited for the study; 112 were vaccinated and included in the final analysis and this report.
Arm/Group Title ADACEL™ Group
Hide Arm/Group Description Participants received 1 dose of ADACEL™ (TdcP vaccine)
Period Title: Overall Study
Started 112 [1]
Completed 112
Not Completed 0
[1]
3 participants were not vaccinated and were not included in the final analysis and in this report.
Arm/Group Title ADACEL™ Group
Hide Arm/Group Description Participants received 1 dose of ADACEL™ (TdcP vaccine)
Overall Number of Baseline Participants 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
<=18 years
112
 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 112 participants
6.8  (0.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
Female
57
  50.9%
Male
55
  49.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 112 participants
112
1.Primary Outcome
Title Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
Hide Description Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.
Time Frame Day 0 and Day 28 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection to each vaccine antigen was evaluated in the per-protocol immunogenicity population
Arm/Group Title ADACEL™ Group
Hide Arm/Group Description:
Participants received 1 dose of ADACEL™ (TdcP vaccine)
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: Percentage of participants
Anti-diphtheria (≥ 0.01 IU/mL, Day 0) 95
Anti-diphtheria (≥ 0.01 IU/mL, Day 28) 99
Anti-diphtheria (≥ 0.1 IU/mL, Day 0) 55
Anti-diphtheria (≥ 0.1 IU/mL, Day 28) 99
Anti-tetanus (≥ 0.01 IU/mL, Day 0) 100
Anti-tetanus (≥ 0.01 IU/mL, Day 28) 100
Anti-tetanus (≥ 0.1 IU/mL, Day 0) 90
Anti-tetanus (≥ 0.1 IU/mL, Day 28) 100
Anti-pertussis toxoid (≥4-fold rise, Day 28) 88
Anti-Filamentous Haemagglutinin ≥4-fold rise Day28 88
Anti-Fimbriae Types 2 & 3 (≥4-fold rise, Day 28) 87
Anti-Pertactin (≥4-fold rise, Day 28) 99
2.Primary Outcome
Title Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
Hide Description GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.
Time Frame Day 0 and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers were evaluated in the per-protocol immunogenicity population.
Arm/Group Title ADACEL™ Group
Hide Arm/Group Description:
Participants received 1 dose of ADACEL™ (TdcP vaccine)
Overall Number of Participants Analyzed 112
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-diphtheria - Day 0
0.120
(0.093 to 0.156)
Anti-diphtheria - Day 28
4.87
(3.67 to 6.47)
Anti-tetanus - Day 0
0.386
(0.311 to 0.479)
Anti-tetanus - Day 28
18.8
(15.9 to 22.2)
Anti-pertussis toxoid - Day 0
9.5
(7.53 to 12.0)
Anti-pertussis toxoid - Day 28
189
(147 to 243)
Anti-Filamentous Haemagglutinin - Day 0
16.7
(13.1 to 21.4)
Anti-Filamentous Haemagglutinin - Day 28
234
(203 to 269)
Anti-Fimbriae Types 2 and 3 - Day 0
31.2
(24.8 to 39.1)
Anti-Fimbriae Types 2 and 3 - Day 28
940
(697 to 1268)
Anti-Pertactin - Day 0
8.89
(7.02 to 11.3)
Anti-Pertactin - Day 28
312
(251 to 388)
3.Secondary Outcome
Title Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
Hide Description The percentage of participants reporting solicited injection site and systemic reactions within 8 days after vaccination with ADACEL™ (TdcP vaccine) when given as a fifth dose
Time Frame Within 8 days of vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.
Arm/Group Title ADACEL™ Group
Hide Arm/Group Description:
Participants received 1 dose of ADACEL™ (TdcP vaccine)
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: Percentage of Participants
Any solicited injection site reaction 67
Any Injection site pain 59
Gd3 Injection site pain(inj limb movement reduced) 4
Any Injection site erythema 33
Grade 3 Injection site erythema (≥ 5 cm) 6
Any Injection site swelling 37
Grade 3 Injection site swelling (≥ 5 cm) 5
Any solicited systemic reaction 58
Any Fever 10
Grade 3 Fever (≥ 39.0 °C) 0
Any Headache 17
Grade 3 Headache (prevents daily activities) 1
Any Malaise 31
Grade 3 Malaise (prevents daily activities) 0
Any Myalgia 53
Grade 3 Myalgia (prevents daily activities) 1
Time Frame Adverse events data were collected from day of vaccination to 28 days post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ADACEL™ Group
Hide Arm/Group Description Participants received 1 dose of ADACEL™ (TdcP vaccine)
All-Cause Mortality
ADACEL™ Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ADACEL™ Group
Affected / at Risk (%) # Events
Total   0/112 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ADACEL™ Group
Affected / at Risk (%) # Events
Total   10/112 (8.93%)    
Infections and infestations   
Nasopharyngitis * 1  10/112 (8.93%)  11
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
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: NCT00258908     History of Changes
Other Study ID Numbers: TD521
First Submitted: November 24, 2005
First Posted: November 28, 2005
Results First Submitted: April 7, 2009
Results First Posted: June 8, 2009
Last Update Posted: April 14, 2016