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Post Marketing Surveillance for ADACEL™ in South Korea

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ClinicalTrials.gov Identifier: NCT01137435
Recruitment Status : Completed
First Posted : June 4, 2010
Results First Posted : January 4, 2017
Last Update Posted : January 4, 2017
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 Diphtheria
Tetanus
Pertussis
Intervention Biological: ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
Enrollment 659

Recruitment Details The Post Marketing Surveillance period was from 23 June 2009 to 22 June 2015 at 7 clinic centers in South Korea.
Pre-assignment Details Case report forms were retrieved from a total of 687 participants during the 6 years post marketing surveillance study; 659 participants were included in the safety analysis.
Arm/Group Title Study Subjects
Hide Arm/Group Description Participants who had returned case report forms and included in the safety analysis.
Period Title: Overall Study
Started 687
Completed 659
Not Completed 28
Reason Not Completed
Lost to Follow-up             24
Off label usage             4
Arm/Group Title Study Subjects
Hide Arm/Group Description Participants who had returned case report forms and included in the safety analysis.
Overall Number of Baseline Participants 659
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 659 participants
<=18 years
275
  41.7%
Between 18 and 65 years
384
  58.3%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 659 participants
24.38  (13.51)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 659 participants
Female
454
  68.9%
Male
205
  31.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 659 participants
659
1.Primary Outcome
Title Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™
Hide Description All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Time Frame 30 days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety events were assessed in the Safety Analysis Set.
Arm/Group Title Study Subjects
Hide Arm/Group Description:
Participants who had returned case report forms and included in the safety analysis.
Overall Number of Participants Analyzed 659
Measure Type: Number
Unit of Measure: Participants
Adverse events 168
Serious adverse events 1
Unexpected adverse events 68
2.Other Pre-specified Outcome
Title Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Hide Description Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Time Frame 30 days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety events were assessed in the Safety Analysis Set.
Arm/Group Title Study Subjects
Hide Arm/Group Description:
Participants who had returned case report forms and included in the safety analysis.
Overall Number of Participants Analyzed 659
Measure Type: Number
Unit of Measure: Participants
Myalgia 26
Bronchitis 11
Rhinitis 6
Coughing 3
Rhinorrhoea 3
Nasopharyngitis 2
Pharyngitis 2
Throat sore 2
Asthma 1
Nasal obstruction 1
Sputum 1
Tonsillitis 1
Malaise 14
Influenza 2
Pain axillary 1
Purulent discharge 1
Gastritis 8
Gastritis acute 3
Gastroenteritis 3
Enteritis 2
Dyspepsia 1
Dermatitis atopic 1
Furuncle (excluding genital) 1
Rash impetiginous 1
Sweating increased 1
Dizziness 3
Allergic conjunctivitis 1
Conjunctivitis 1
ALT increased 1
AST increased 1
Hand foot mouth disease 1
3.Other Pre-specified Outcome
Title Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Hide Description All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Time Frame 30 days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety events were assessed in the Safety Analysis Set.
Arm/Group Title Study Subjects
Hide Arm/Group Description:
Participants who had returned case report forms and included in the safety analysis.
Overall Number of Participants Analyzed 659
Measure Type: Number
Unit of Measure: Participants
Injection-site Pain 108
Injection-site Erythema 46
Injection-site Swelling 42
Injection-site Itching 5
Injection-site Bruising 1
Myalgia 26
Arthralgia 1
Bronchitis 11
Rhinitis 6
Coughing 3
Rhinorrhoea 3
Nasopharyngitis 2
Pharyngitis 2
Throat sore 2
Asthma 1
Nasal obstruction 1
Sputum 1
Tonsillitis 1
Malaise 14
Fever 7
Influenza 2
Knee pain 1
Pain axillary 1
Purulent discharge 1
Gastritis 8
Gastritis acute 3
Gastroenteritis 3
Diarrhoea 2
Enteritis 2
Dyspepsia 1
Nausea 1
Vomiting 1
Headache 13
Dizziness 3
Dermatitis atopic 1
Furuncle (excluding genital) 1
Itching 1
Rash 1
Rash impetiginous 1
Sweating increased 1
Allergic conjunctivitis 1
Conjunctivitis 1
ALT increased 1
AST increased 1
Hand foot and mouth disease 1
4.Other Pre-specified Outcome
Title Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Hide Description

Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Solicited injection-site: Pain, Prevents daily activities; Erythema and Swelling,> 10 cm. Grade 3 Solicited systemic reactions: Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities.

All events reported by vaccinated subjects within 7 days post-vaccination during the 6 year post marketing surveillance period.

Time Frame 7 days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety events were assessed in the Safety Analysis Set.
Arm/Group Title Study Subjects
Hide Arm/Group Description:
Participants who had returned case report forms and included in the safety analysis.
Overall Number of Participants Analyzed 659
Measure Type: Number
Unit of Measure: Number of Events
Any Injection-site Pain 108
Grade 3 Injection-site Pain 0
Any Injection-site Erythema 46
Grade 3 Injection-site Erythema 0
Any Injection-site Swelling 42
Grade 3 Injection-site Swelling 1
Any Fever 4
Grade 3 Fever 1
Any Headache 12
Grade 3 Headache 0
Any Malaise 14
Grade 3 Malaise 1
Any Myalgia 24
Grade 3 Myalgia 0
Time Frame Adverse event data were collected within 30 days of each vaccination during the 6 years post marketing surveillance period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Subjects
Hide Arm/Group Description Participants who had returned case report forms and included in the safety analysis.
All-Cause Mortality
Study Subjects
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Subjects
Affected / at Risk (%) # Events
Total   1/659 (0.15%)    
General disorders   
Knee pain * 1  1/659 (0.15%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Study Subjects
Affected / at Risk (%) # Events
Total   108/659 (16.39%)    
General disorders   
Injection-site Pain  1  108/659 (16.39%)  108
Injection-site Erythema  1  46/659 (6.98%)  46
Injection-site Swelling  1  42/659 (6.37%)  42
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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: NCT01137435     History of Changes
Other Study ID Numbers: Td533
UTN: U1111-1112-8558 ( Other Identifier: WHO )
First Submitted: June 3, 2010
First Posted: June 4, 2010
Results First Submitted: November 6, 2016
Results First Posted: January 4, 2017
Last Update Posted: January 4, 2017