Trial Outcomes & Findings for Post Marketing Surveillance for ADACEL™ in South Korea (NCT NCT01137435)
NCT ID: NCT01137435
Last Updated: 2022-04-28
Results Overview
All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
659 participants
Primary outcome timeframe
30 days post-vaccination
Results posted on
2022-04-28
Participant Flow
The Post Marketing Surveillance period was from 23 June 2009 to 22 June 2015 at 7 clinic centers in South Korea.
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.
Participant milestones
| Measure |
Study Subjects
Participants who had returned case report forms and included in the safety analysis.
|
|---|---|
|
Overall Study
STARTED
|
687
|
|
Overall Study
COMPLETED
|
659
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Study Subjects
Participants who had returned case report forms and included in the safety analysis.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
24
|
|
Overall Study
Off label usage
|
4
|
Baseline Characteristics
Post Marketing Surveillance for ADACEL™ in South Korea
Baseline characteristics by cohort
| Measure |
Study Subjects
n=659 Participants
Participants who had returned case report forms and included in the safety analysis.
|
|---|---|
|
Age, Categorical
<=18 years
|
275 Participants
n=113 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
384 Participants
n=113 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=113 Participants
|
|
Age, Continuous
|
24.38 Years
STANDARD_DEVIATION 13.51 • n=113 Participants
|
|
Sex: Female, Male
Female
|
454 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=113 Participants
|
|
Region of Enrollment
Korea, Republic of
|
659 Participants
n=113 Participants
|
PRIMARY outcome
Timeframe: 30 days post-vaccinationPopulation: Safety events were assessed in the Safety Analysis Set.
All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Outcome measures
| Measure |
Study Subjects
n=659 Participants
Participants who had returned case report forms and included in the safety analysis.
|
|---|---|
|
Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™
Adverse events
|
168 Participants
|
|
Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™
Serious adverse events
|
1 Participants
|
|
Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™
Unexpected adverse events
|
68 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post-vaccinationPopulation: Safety events were assessed in the Safety Analysis Set.
Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Outcome measures
| Measure |
Study Subjects
n=659 Participants
Participants who had returned case report forms and included in the safety analysis.
|
|---|---|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Myalgia
|
26 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Bronchitis
|
11 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Rhinitis
|
6 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Coughing
|
3 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Rhinorrhoea
|
3 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Nasopharyngitis
|
2 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Pharyngitis
|
2 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Throat sore
|
2 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Asthma
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Nasal obstruction
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Sputum
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Tonsillitis
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Malaise
|
14 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Influenza
|
2 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Pain axillary
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Purulent discharge
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Gastritis
|
8 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Gastritis acute
|
3 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Gastroenteritis
|
3 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Enteritis
|
2 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Dyspepsia
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Dermatitis atopic
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Furuncle (excluding genital)
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Rash impetiginous
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Sweating increased
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Dizziness
|
3 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Allergic conjunctivitis
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Conjunctivitis
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
ALT increased
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
AST increased
|
1 Participants
|
|
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Hand foot mouth disease
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post-vaccinationPopulation: Safety events were assessed in the Safety Analysis Set.
All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Outcome measures
| Measure |
Study Subjects
n=659 Participants
Participants who had returned case report forms and included in the safety analysis.
|
|---|---|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
ALT increased
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Injection-site Pain
|
108 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Injection-site Erythema
|
46 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Injection-site Swelling
|
42 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Injection-site Itching
|
5 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Injection-site Bruising
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Myalgia
|
26 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Arthralgia
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Bronchitis
|
11 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Rhinitis
|
6 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Coughing
|
3 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Rhinorrhoea
|
3 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Nasopharyngitis
|
2 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Pharyngitis
|
2 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Throat sore
|
2 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Asthma
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Nasal obstruction
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Sputum
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Tonsillitis
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Malaise
|
14 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Fever
|
7 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Influenza
|
2 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Knee pain
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Pain axillary
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Purulent discharge
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Gastritis
|
8 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Gastritis acute
|
3 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Gastroenteritis
|
3 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Diarrhoea
|
2 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Enteritis
|
2 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Dyspepsia
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Nausea
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Vomiting
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Headache
|
13 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Dizziness
|
3 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Dermatitis atopic
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Furuncle (excluding genital)
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Itching
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Rash
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Rash impetiginous
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Sweating increased
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Allergic conjunctivitis
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Conjunctivitis
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
AST increased
|
1 Participants
|
|
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
Hand foot and mouth disease
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 days post-vaccinationPopulation: Safety events were assessed in the Safety Analysis Set.
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.
Outcome measures
| Measure |
Study Subjects
n=659 Participants
Participants who had returned case report forms and included in the safety analysis.
|
|---|---|
|
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Any Injection-site Pain
|
108 Number of Events
|
|
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
|
|
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Any Injection-site Erythema
|
46 Number of Events
|
|
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
|
|
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Any Injection-site Swelling
|
42 Number of Events
|
|
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
|
|
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Any Fever
|
4 Number of Events
|
|
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Grade 3 Fever
|
1 Number of Events
|
|
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Any Headache
|
12 Number of Events
|
|
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Grade 3 Headache
|
0 Number of Events
|
|
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Any Malaise
|
14 Number of Events
|
|
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Grade 3 Malaise
|
1 Number of Events
|
|
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Any Myalgia
|
24 Number of Events
|
|
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Grade 3 Myalgia
|
0 Number of Events
|
Adverse Events
Study Subjects
Serious events: 1 serious events
Other events: 108 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Subjects
n=659 participants at risk
Participants who had returned case report forms and included in the safety analysis.
|
|---|---|
|
General disorders
Knee pain
|
0.15%
1/659 • Number of events 1 • Adverse event data were collected within 30 days of each vaccination during the 6 years post marketing surveillance period.
|
Other adverse events
| Measure |
Study Subjects
n=659 participants at risk
Participants who had returned case report forms and included in the safety analysis.
|
|---|---|
|
General disorders
Injection-site Pain
|
16.4%
108/659 • Number of events 108 • Adverse event data were collected within 30 days of each vaccination during the 6 years post marketing surveillance period.
|
|
General disorders
Injection-site Erythema
|
7.0%
46/659 • Number of events 46 • Adverse event data were collected within 30 days of each vaccination during the 6 years post marketing surveillance period.
|
|
General disorders
Injection-site Swelling
|
6.4%
42/659 • Number of events 42 • Adverse event data were collected within 30 days of each vaccination during the 6 years post marketing 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