Diphtheria, Pertussis, Tetanus
Conditions
Keywords
Adacel, Diphtheria, Tetanus, Pertussis
Brief summary
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 Basic standard for reexamination of new drug. The study objective is to assess within 30 days post-administration, the safety of ADACEL™ administered under the real clinical practice.
Interventions
BIOLOGICALADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
0.5 mL, intramuscular (IM)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
: * Subjects who are 11 through 64 years of age (as indicated in the currently approved local product labeling) , who are given a single dose of the study vaccine, during a routine health-care visit, as active booster immunization for the prevention of tetanus, diphtheria and pertussis. * Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject.
Exclusion criteria
: * None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™ | 30 days post-vaccination | All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | 30 days post-vaccination | Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period. |
| Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | 30 days post-vaccination | All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period. |
| Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | 7 days post-vaccination | 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. |
Countries
South Korea
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Study Subjects Participants who had returned case report forms and included in the safety analysis. | 659 |
| Total | 659 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 24 |
| Overall Study | Off label usage | 4 |
Baseline characteristics
| Characteristic | Study Subjects |
|---|---|
| Age, Categorical <=18 years | 275 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 384 Participants |
| Age, Continuous | 24.38 Years STANDARD_DEVIATION 13.51 |
| Region of Enrollment Korea, Republic of | 659 Participants |
| Sex: Female, Male Female | 454 Participants |
| Sex: Female, Male Male | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 108 / 659 |
| serious Total, serious adverse events | 1 / 659 |
Outcome results
Primary
Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™
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
Population: Safety events were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Subjects | Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™ | Adverse events | 168 Participants |
| Study Subjects | Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™ | Serious adverse events | 1 Participants |
| Study Subjects | Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™ | Unexpected adverse events | 68 Participants |
Other Pre-specified
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
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
Population: Safety events were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Injection-site Pain | 108 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Injection-site Erythema | 46 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Dermatitis atopic | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Furuncle (excluding genital) | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Itching | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Rash | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Rash impetiginous | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Sweating increased | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Injection-site Swelling | 42 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Injection-site Itching | 5 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Injection-site Bruising | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Myalgia | 26 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Arthralgia | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Bronchitis | 11 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Rhinitis | 6 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Coughing | 3 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Rhinorrhoea | 3 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Nasopharyngitis | 2 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Pharyngitis | 2 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Throat sore | 2 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Asthma | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Nasal obstruction | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Sputum | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Tonsillitis | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Malaise | 14 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Fever | 7 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Influenza | 2 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Knee pain | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Pain axillary | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Purulent discharge | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Gastritis | 8 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Gastritis acute | 3 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Gastroenteritis | 3 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Diarrhoea | 2 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Enteritis | 2 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Dyspepsia | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Nausea | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Vomiting | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Headache | 13 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Dizziness | 3 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Allergic conjunctivitis | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Conjunctivitis | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | ALT increased | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | AST increased | 1 Participants |
| Study Subjects | Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™ | Hand foot and mouth disease | 1 Participants |
Other Pre-specified
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
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
Population: Safety events were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Rash impetiginous | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Sweating increased | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Dizziness | 3 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Myalgia | 26 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Bronchitis | 11 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Rhinitis | 6 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Coughing | 3 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Rhinorrhoea | 3 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Nasopharyngitis | 2 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Pharyngitis | 2 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Throat sore | 2 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Asthma | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Nasal obstruction | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Sputum | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Tonsillitis | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Malaise | 14 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Influenza | 2 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Pain axillary | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Purulent discharge | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Gastritis | 8 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Gastritis acute | 3 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Gastroenteritis | 3 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Enteritis | 2 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Dyspepsia | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Dermatitis atopic | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Furuncle (excluding genital) | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Allergic conjunctivitis | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Conjunctivitis | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | ALT increased | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | AST increased | 1 Participants |
| Study Subjects | Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™ | Hand foot mouth disease | 1 Participants |
Other Pre-specified
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
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
Population: Safety events were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Any Injection-site Erythema | 46 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Grade 3 Injection-site Swelling | 1 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Grade 3 Headache | 0 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Grade 3 Myalgia | 0 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Any Injection-site Pain | 108 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Grade 3 Injection-site Pain | 0 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Grade 3 Injection-site Erythema | 0 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Any Injection-site Swelling | 42 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Any Fever | 4 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Grade 3 Fever | 1 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Any Headache | 12 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Any Malaise | 14 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Grade 3 Malaise | 1 Number of Events |
| Study Subjects | Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™ | Any Myalgia | 24 Number of Events |