Diphtheria, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Poliomyelitis, TETRAXIM™
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.
Detailed description
Primary vaccination will be administered from 2 months and booster vaccination from age 4 to 6 years.
Interventions
BIOLOGICALTETRAXIM™: 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
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
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 details
Of the 662 participants whose case report forms were retrieved, 647 participants were included in the safety analysis.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 647 |
| Total | 647 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Off label usage | 3 |
Baseline characteristics
| Characteristic | TETRAXIM™ Vaccination and Booster Group |
|---|---|
| Age, Categorical <=18 years | 647 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 8.16 Months STANDARD_DEVIATION 13.43 |
| Region of Enrollment Korea, Republic of | 647 Participants |
| Sex: Female, Male Female | 327 Participants |
| Sex: Female, Male Male | 320 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 79 / 647 |
| serious Total, serious adverse events | 0 / 647 |
Outcome results
Primary
Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
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
Population: Adverse events were reported from the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Bronchitis | 76 Participants |
| TETRAXIM™ Vaccination and Booster Group | 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 |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Coryza | 10 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Bronchiolitis | 6 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Coughing | 4 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Rhinitis | 4 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Common cold | 3 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Tonsillitis | 3 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Allergic rhinitis | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Asthma | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Croup | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Nasopharyngitis | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Enteritis | 20 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Gastroenteritis | 5 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Constipation | 2 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Gastritis acute | 2 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Dermatitis contact | 15 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Dermatitis atopic | 4 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Dermatitis diaper | 3 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Rash impetiginous | 3 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Contact eczema | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Dermatitis seborrhoeic | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Eczema allergic | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Otitis media | 5 Participants |
| TETRAXIM™ Vaccination and Booster Group | 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 |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™. | Conjunctivitis | 2 Participants |
| TETRAXIM™ Vaccination and Booster Group | 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
Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
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
Population: Solicited adverse events were reported from the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. | Any Injection-site Tenderness | 20 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. | Grade 3 Injection-site Tenderness | 0 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. | Any Injection-site Erythema | 10 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. | Grade 3 Injection-site Erythema | 0 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. | Any Injection-site Swelling | 10 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. | Grade 3 Injection-site Swelling | 0 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. | Any Fever | 6 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. | Grade 3 Fever | 0 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. | Any Crying abnormal | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™. | Grade 3 Crying abnormal | 0 Participants |
Other Pre-specified
Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
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
Population: Unsolicited adverse events were reported from the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Eczema allergic | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Fever | 3 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Otitis media | 6 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Hand foot and mouth disease | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Conjunctivitis | 2 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Red eye | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Irritability | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Bronchitis | 79 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Upper respiratory tract infection | 32 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Coryza | 10 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Bronchiolitis | 6 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Coughing | 4 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Rhinitis | 4 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Common cold | 3 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Tonsillitis | 3 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Allergic rhinitis | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Asthma | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Croup | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Nasopharyngitis | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Enteritis | 20 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Gastroenteritis | 5 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Diarrhoea | 4 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Constipation | 2 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Gastritis acute | 2 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Vomiting | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Dermatitis contact | 15 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Dermatitis atopic | 4 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Dermatitis diaper | 3 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Rash impetiginous | 3 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Contact eczema | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™. | Dermatitis seborrhoeic | 1 Participants |
Other Pre-specified
Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.
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
Population: Adverse events were reported from the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TETRAXIM™ Vaccination and Booster Group | Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™. | Gender; Male (N=320) | 82 Participants |
| TETRAXIM™ Vaccination and Booster Group | Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™. | Gender; Female (N=327) | 99 Participants |
| TETRAXIM™ Vaccination and Booster Group | Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™. | Age; <12 months (N=602) | 167 Participants |
| TETRAXIM™ Vaccination and Booster Group | Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™. | Age; 48 to <60 months (N=35) | 12 Participants |
| TETRAXIM™ Vaccination and Booster Group | Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™. | Age; 60 to <72 months (N=7) | 1 Participants |
| TETRAXIM™ Vaccination and Booster Group | Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™. | Age; ≥72 months (N=3) | 1 Participants |