Regulatory Post-Marketing Surveillance Study for TETRAXIM™
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01437423
Collaborator
(none)
600
1
1
53
11.3
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No. 2009-46 "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Primary vaccination will be administered from 2 months and booster vaccination from age 4 to 6 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
600 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Regulatory Post-Marketing Surveillance (PMS) Study for TETRAXIM™(Combined Vaccine of Adsorbed Diphtheria, Tetanus, Acellular Pertussis and Enhanced Inactivated Poliomyelitis)
Study Start Date
:
Jun 1, 2011
Actual Primary Completion Date
:
Nov 1, 2015
Actual Study Completion Date
:
Nov 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TETRAXIM™ vaccine Participants will receive a primary or booster dose of TETRAXIM™ |
Biological: TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
0.5 mL, Intramuscular at 2, 4, 6 months (Primary) or at 4 to 6 years (Booster) vaccination
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. [Up to 30 days post-primary and booster vaccination]
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.
Other Outcome Measures
- Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. [Up to 30 days post-primary and booster vaccination]
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.
- Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. [Up to 30 days post-primary and booster of TETRAXIM™ vaccination]
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
- Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™. [Up to 30 days post-primary and booster of vaccination]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Months
to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Subjects who are 2 months or more of age (as indicated in the currently approved local product labeling) and who are given the study vaccine at least one dose or more, during a routine health-care visit, as primary immunization or booster immunization for the prevention of diphtheria, tetanus, pertussis, poliomyelitis.
-
Written informed consent obtained from the subject's parents/legal representative.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur SA
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01437423
Other Study ID Numbers:
- E2I59
- U1111-1114-7745
First Posted:
Sep 20, 2011
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Sanofi Pasteur, a Sanofi Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| 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 Detail | 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 |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | TETRAXIM™ Vaccination and Booster Group |
|---|---|
| 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 Participants | 647 |
| Age (Count of Participants) | |
| <=18 years |
647
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Age (Months) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Months] |
8.16
(13.43)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
327
50.5%
|
| Male |
320
49.5%
|
| Region of Enrollment (Number) [Number] | |
| Korea, Republic of |
647
100%
|
Outcome Measures
| Title | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Adverse events were reported from the Safety Analysis Set. |
| Arm/Group Title | TETRAXIM™ Vaccination and Booster Group |
|---|---|
| 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. |
| Measure Participants | 647 |
| Bronchitis |
76
11.7%
|
| Upper respiratory tract infection |
30
4.6%
|
| Coryza |
10
1.5%
|
| Bronchiolitis |
6
0.9%
|
| Coughing |
4
0.6%
|
| Rhinitis |
4
0.6%
|
| Common cold |
3
0.5%
|
| Tonsillitis |
3
0.5%
|
| Allergic rhinitis |
1
0.2%
|
| Asthma |
1
0.2%
|
| Croup |
1
0.2%
|
| Nasopharyngitis |
1
0.2%
|
| Enteritis |
20
3.1%
|
| Gastroenteritis |
5
0.8%
|
| Constipation |
2
0.3%
|
| Gastritis acute |
2
0.3%
|
| Dermatitis contact |
15
2.3%
|
| Dermatitis atopic |
4
0.6%
|
| Dermatitis diaper |
3
0.5%
|
| Rash impetiginous |
3
0.5%
|
| Contact eczema |
1
0.2%
|
| Dermatitis seborrhoeic |
1
0.2%
|
| Eczema allergic |
1
0.2%
|
| Otitis media |
5
0.8%
|
| Hand foot and mouth disease |
1
0.2%
|
| Conjunctivitis |
2
0.3%
|
| Red eye |
1
0.2%
|
| Title | Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited adverse events were reported from the Safety Analysis Set. |
| Arm/Group Title | TETRAXIM™ Vaccination and Booster Group |
|---|---|
| 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. |
| Measure Participants | 647 |
| Any Injection-site Tenderness |
20
3.1%
|
| Grade 3 Injection-site Tenderness |
0
0%
|
| Any Injection-site Erythema |
10
1.5%
|
| Grade 3 Injection-site Erythema |
0
0%
|
| Any Injection-site Swelling |
10
1.5%
|
| Grade 3 Injection-site Swelling |
0
0%
|
| Any Fever |
6
0.9%
|
| Grade 3 Fever |
0
0%
|
| Any Crying abnormal |
1
0.2%
|
| Grade 3 Crying abnormal |
0
0%
|
| Title | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Unsolicited adverse events were reported from the Safety Analysis Set. |
| Arm/Group Title | TETRAXIM™ Vaccination and Booster Group |
|---|---|
| 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. |
| Measure Participants | 647 |
| Bronchitis |
79
12.2%
|
| Upper respiratory tract infection |
32
4.9%
|
| Coryza |
10
1.5%
|
| Bronchiolitis |
6
0.9%
|
| Coughing |
4
0.6%
|
| Rhinitis |
4
0.6%
|
| Common cold |
3
0.5%
|
| Tonsillitis |
3
0.5%
|
| Allergic rhinitis |
1
0.2%
|
| Asthma |
1
0.2%
|
| Croup |
1
0.2%
|
| Nasopharyngitis |
1
0.2%
|
| Enteritis |
20
3.1%
|
| Gastroenteritis |
5
0.8%
|
| Diarrhoea |
4
0.6%
|
| Constipation |
2
0.3%
|
| Gastritis acute |
2
0.3%
|
| Vomiting |
1
0.2%
|
| Dermatitis contact |
15
2.3%
|
| Dermatitis atopic |
4
0.6%
|
| Dermatitis diaper |
3
0.5%
|
| Rash impetiginous |
3
0.5%
|
| Contact eczema |
1
0.2%
|
| Dermatitis seborrhoeic |
1
0.2%
|
| Eczema allergic |
1
0.2%
|
| Fever |
3
0.5%
|
| Otitis media |
6
0.9%
|
| Hand foot and mouth disease |
1
0.2%
|
| Conjunctivitis |
2
0.3%
|
| Red eye |
1
0.2%
|
| Irritability |
1
0.2%
|
| Title | Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™. |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Adverse events were reported from the Safety Analysis Set. |
| Arm/Group Title | TETRAXIM™ Vaccination and Booster Group |
|---|---|
| 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. |
| Measure Participants | 647 |
| Gender; Male (N=320) |
82
12.7%
|
| Gender; Female (N=327) |
99
15.3%
|
| Age; <12 months (N=602) |
167
25.8%
|
| Age; 48 to <60 months (N=35) |
12
1.9%
|
| Age; 60 to <72 months (N=7) |
1
0.2%
|
| Age; ≥72 months (N=3) |
1
0.2%
|
Adverse Events
| 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 | ||
| Arm/Group Title | TETRAXIM™ Vaccination and Booster Group | |
| 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 (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| TETRAXIM™ Vaccination and Booster Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/647 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| TETRAXIM™ Vaccination and Booster Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 79/647 (12.2%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Bronchitis | 79/647 (12.2%) | 79 |
| Upper respiratory tract infection | 32/647 (4.9%) | 32 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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. |
| Phone | |
| RegistryContactUs@sanofipasteur.com |
Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01437423
Other Study ID Numbers:
- E2I59
- U1111-1114-7745
First Posted:
Sep 20, 2011
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022