Trial Outcomes & Findings for Regulatory Post-Marketing Surveillance Study for TETRAXIM™ (NCT NCT01437423)
NCT ID: NCT01437423
Last Updated: 2022-03-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
600 participants
Primary outcome timeframe
Up to 30 days post-primary and booster vaccination
Results posted on
2022-03-28
Participant Flow
Study participants were enrolled for a 6 year surveillance period (31 August 2009 to 30 August 2015) at 8 clinic centers in Korea.
Of the 662 participants whose case report forms were retrieved, 647 participants were included in the safety analysis.
Participant milestones
| Measure |
TETRAXIM™ Vaccination and Booster Group
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 Study
STARTED
|
662
|
|
Overall Study
COMPLETED
|
647
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
TETRAXIM™ Vaccination and Booster Group
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 Study
Lost to Follow-up
|
12
|
|
Overall Study
Off label usage
|
3
|
Baseline Characteristics
Regulatory Post-Marketing Surveillance Study for TETRAXIM™
Baseline characteristics by cohort
| Measure |
TETRAXIM™ Vaccination and Booster Group
n=647 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
647 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8.16 Months
STANDARD_DEVIATION 13.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
327 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
320 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
647 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days post-primary and booster vaccinationPopulation: Adverse events were reported from the Safety Analysis Set.
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.
Outcome measures
| Measure |
TETRAXIM™ Vaccination and Booster Group
n=647 Participants
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.
|
|---|---|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Bronchitis
|
76 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Upper respiratory tract infection
|
30 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Coryza
|
10 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Bronchiolitis
|
6 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Coughing
|
4 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Rhinitis
|
4 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Common cold
|
3 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Tonsillitis
|
3 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Allergic rhinitis
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Asthma
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Croup
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Nasopharyngitis
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Enteritis
|
20 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Gastroenteritis
|
5 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Constipation
|
2 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Gastritis acute
|
2 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Dermatitis contact
|
15 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Dermatitis atopic
|
4 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Dermatitis diaper
|
3 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Rash impetiginous
|
3 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Contact eczema
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Dermatitis seborrhoeic
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Eczema allergic
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Otitis media
|
5 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Hand foot and mouth disease
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Conjunctivitis
|
2 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
Red eye
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days post-primary and booster vaccinationPopulation: Solicited adverse events were reported from the Safety Analysis Set.
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.
Outcome measures
| Measure |
TETRAXIM™ Vaccination and Booster Group
n=647 Participants
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.
|
|---|---|
|
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Any Injection-site Tenderness
|
20 Participants
|
|
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Grade 3 Injection-site Tenderness
|
0 Participants
|
|
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Any Injection-site Erythema
|
10 Participants
|
|
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Grade 3 Injection-site Erythema
|
0 Participants
|
|
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Any Injection-site Swelling
|
10 Participants
|
|
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Grade 3 Injection-site Swelling
|
0 Participants
|
|
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Any Fever
|
6 Participants
|
|
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Grade 3 Fever
|
0 Participants
|
|
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Any Crying abnormal
|
1 Participants
|
|
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
Grade 3 Crying abnormal
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days post-primary and booster of TETRAXIM™ vaccinationPopulation: Unsolicited adverse events were reported from the Safety Analysis Set.
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
Outcome measures
| Measure |
TETRAXIM™ Vaccination and Booster Group
n=647 Participants
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.
|
|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Bronchitis
|
79 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Upper respiratory tract infection
|
32 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Coryza
|
10 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Bronchiolitis
|
6 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Coughing
|
4 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Rhinitis
|
4 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Common cold
|
3 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Tonsillitis
|
3 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Allergic rhinitis
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Asthma
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Croup
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Nasopharyngitis
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Enteritis
|
20 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Gastroenteritis
|
5 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Diarrhoea
|
4 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Constipation
|
2 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Gastritis acute
|
2 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Vomiting
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Dermatitis contact
|
15 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Dermatitis atopic
|
4 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Dermatitis diaper
|
3 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Rash impetiginous
|
3 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Contact eczema
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Dermatitis seborrhoeic
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Eczema allergic
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Fever
|
3 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Otitis media
|
6 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Hand foot and mouth disease
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Conjunctivitis
|
2 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Red eye
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
Irritability
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days post-primary and booster of vaccinationPopulation: Adverse events were reported from the Safety Analysis Set.
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.
Outcome measures
| Measure |
TETRAXIM™ Vaccination and Booster Group
n=647 Participants
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.
|
|---|---|
|
Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.
Gender; Male (N=320)
|
82 Participants
|
|
Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.
Gender; Female (N=327)
|
99 Participants
|
|
Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.
Age; <12 months (N=602)
|
167 Participants
|
|
Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.
Age; 48 to <60 months (N=35)
|
12 Participants
|
|
Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.
Age; 60 to <72 months (N=7)
|
1 Participants
|
|
Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.
Age; ≥72 months (N=3)
|
1 Participants
|
Adverse Events
TETRAXIM™ Vaccination and Booster Group
Serious events: 0 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TETRAXIM™ Vaccination and Booster Group
n=647 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
12.2%
79/647 • Number of events 79 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
4.9%
32/647 • Number of events 32 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER