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Trial record 1 of 1 for:    E2I59
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Regulatory Post-Marketing Surveillance Study for TETRAXIM™

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ClinicalTrials.gov Identifier: NCT01437423
Recruitment Status : Completed
First Posted : September 20, 2011
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
Poliomyelitis
Intervention Biological: TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
Enrollment 600
Recruitment Details Study participants were enrolled for a 6 year surveillance period (31 August 2009 to 30 August 2015) at 8 clinic centers in Korea.
Pre-assignment Details Of the 662 participants whose case report forms were retrieved, 647 participants were included in the safety analysis.
Arm/Group Title TETRAXIM™ Vaccination and Booster Group
Hide Arm/Group Description Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
Period Title: Overall Study
Started 662
Completed 647
Not Completed 15
Reason Not Completed
Lost to Follow-up             12
Off label usage             3
Arm/Group Title TETRAXIM™ Vaccination and Booster Group
Hide Arm/Group Description Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
Overall Number of Baseline Participants 647
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 647 participants
<=18 years
647
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 647 participants
8.16  (13.43)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 647 participants
Female
327
  50.5%
Male
320
  49.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 647 participants
647
1.Primary Outcome
Title Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Hide Description The number of participants reporting unexpected adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis)) during 6 year surveillance period.
Time Frame Up to 30 days post-primary and booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse events were reported from the Safety Analysis Set.
Arm/Group Title TETRAXIM™ Vaccination and Booster Group
Hide Arm/Group Description:
Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
Overall Number of Participants Analyzed 647
Measure Type: Number
Unit of Measure: Participants
Bronchitis 76
Upper respiratory tract infection 30
Coryza 10
Bronchiolitis 6
Coughing 4
Rhinitis 4
Common cold 3
Tonsillitis 3
Allergic rhinitis 1
Asthma 1
Croup 1
Nasopharyngitis 1
Enteritis 20
Gastroenteritis 5
Constipation 2
Gastritis acute 2
Dermatitis contact 15
Dermatitis atopic 4
Dermatitis diaper 3
Rash impetiginous 3
Contact eczema 1
Dermatitis seborrhoeic 1
Eczema allergic 1
Otitis media 5
Hand foot and mouth disease 1
Conjunctivitis 2
Red eye 1
2.Other Pre-specified Outcome
Title Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Hide Description Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature) and Crying abnormal. Grade 3 Injection-site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, >39.5˚C; Crying abnormal, >3 hours.
Time Frame Up to 30 days post-primary and booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited adverse events were reported from the Safety Analysis Set.
Arm/Group Title TETRAXIM™ Vaccination and Booster Group
Hide Arm/Group Description:
Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
Overall Number of Participants Analyzed 647
Measure Type: Number
Unit of Measure: Participants
Any Injection-site Tenderness 20
Grade 3 Injection-site Tenderness 0
Any Injection-site Erythema 10
Grade 3 Injection-site Erythema 0
Any Injection-site Swelling 10
Grade 3 Injection-site Swelling 0
Any Fever 6
Grade 3 Fever 0
Any Crying abnormal 1
Grade 3 Crying abnormal 0
3.Other Pre-specified Outcome
Title Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Hide Description The number of participants reporting unsolicited adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 year surveillance period
Time Frame Up to 30 days post-primary and booster of TETRAXIM™ vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Unsolicited adverse events were reported from the Safety Analysis Set.
Arm/Group Title TETRAXIM™ Vaccination and Booster Group
Hide Arm/Group Description:
Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
Overall Number of Participants Analyzed 647
Measure Type: Number
Unit of Measure: Participants
Bronchitis 79
Upper respiratory tract infection 32
Coryza 10
Bronchiolitis 6
Coughing 4
Rhinitis 4
Common cold 3
Tonsillitis 3
Allergic rhinitis 1
Asthma 1
Croup 1
Nasopharyngitis 1
Enteritis 20
Gastroenteritis 5
Diarrhoea 4
Constipation 2
Gastritis acute 2
Vomiting 1
Dermatitis contact 15
Dermatitis atopic 4
Dermatitis diaper 3
Rash impetiginous 3
Contact eczema 1
Dermatitis seborrhoeic 1
Eczema allergic 1
Fever 3
Otitis media 6
Hand foot and mouth disease 1
Conjunctivitis 2
Red eye 1
Irritability 1
4.Other Pre-specified Outcome
Title Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.
Hide Description The number of participants reporting adverse events by demographic characteristic following a primary series injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 years surveillance period is reported.
Time Frame Up to 30 days post-primary and booster of vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse events were reported from the Safety Analysis Set.
Arm/Group Title TETRAXIM™ Vaccination and Booster Group
Hide Arm/Group Description:
Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
Overall Number of Participants Analyzed 647
Measure Type: Number
Unit of Measure: Participants
Gender; Male (N=320) 82
Gender; Female (N=327) 99
Age; <12 months (N=602) 167
Age; 48 to <60 months (N=35) 12
Age; 60 to <72 months (N=7) 1
Age; ≥72 months (N=3) 1
Time Frame Adverse event data (solicited and unsolicited) were collected up to 30 days after the primary series injection of TETRAXIM™ during the 6 year surveillance period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TETRAXIM™ Vaccination and Booster Group
Hide Arm/Group Description Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
All-Cause Mortality
TETRAXIM™ Vaccination and Booster Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TETRAXIM™ Vaccination and Booster Group
Affected / at Risk (%) # Events
Total   0/647 (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%
TETRAXIM™ Vaccination and Booster Group
Affected / at Risk (%) # Events
Total   79/647 (12.21%)    
Respiratory, thoracic and mediastinal disorders   
Bronchitis * 1  79/647 (12.21%)  79
Upper respiratory tract infection * 1  32/647 (4.95%)  32
*
Indicates events were collected by non-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: NCT01437423     History of Changes
Other Study ID Numbers: E2I59
U1111-1114-7745 ( Other Identifier: WHO )
First Submitted: September 19, 2011
First Posted: September 20, 2011
Results First Submitted: November 6, 2016
Results First Posted: January 4, 2017
Last Update Posted: January 4, 2017