Trial Outcomes & Findings for Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea (NCT NCT01929291)
NCT ID: NCT01929291
Last Updated: 2019-09-25
Results Overview
Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea.
Recruitment status
COMPLETED
Target enrollment
682 participants
Primary outcome timeframe
During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
Results posted on
2019-09-25
Participant Flow
A total of 682 subjects case report forms were retrieved during the post-marketing surveillance period. Among those, 672 subjects were assessed for safety and the safety data from 10 subjects who did not fulfilled inclusion/exclusion criteria were analyzed separately.
Participant milestones
| Measure |
Boostrix Group
Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea.
|
|---|---|
|
Overall Study
STARTED
|
672
|
|
Overall Study
COMPLETED
|
672
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea
Baseline characteristics by cohort
| Measure |
Boostrix Group
n=672 Participants
Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea.
|
|---|---|
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Age, Continuous
|
44.38 Years
STANDARD_DEVIATION 14.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
451 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
221 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Korean
|
672 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the study vaccine.
Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea.
Outcome measures
| Measure |
Boostrix Group
n=672 Participants
Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea.
|
|---|---|
|
Number of Unexpected Adverse Events (AEs)
|
65 Events
|
PRIMARY outcome
Timeframe: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the study vaccine.
Expected AEs were defined as an adverse event that was expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information in Korea.
Outcome measures
| Measure |
Boostrix Group
n=672 Participants
Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea.
|
|---|---|
|
Number of Expected AEs.
|
59 Events
|
PRIMARY outcome
Timeframe: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the study vaccine.
An SAE was defined as any AE that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or that was a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Boostrix Group
n=672 Participants
Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea.
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|---|---|
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Number of Subjects With Serious Adverse Events (SAEs)
|
6 Participants
|
Adverse Events
Boostrix Group
Serious events: 6 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Boostrix Group
n=672 participants at risk
Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea.
|
|---|---|
|
Gastrointestinal disorders
Gastroenteritis
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Reproductive system and breast disorders
Genital infection
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Reproductive system and breast disorders
Birth premature
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Fever
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
Other adverse events
| Measure |
Boostrix Group
n=672 participants at risk
Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea.
|
|---|---|
|
General disorders
Injection site pruritus
|
0.45%
3/672 • Number of events 3 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Injection site rash
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Injection site anaesthesia
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Injection site warmth
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
14/672 • Number of events 14 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.74%
5/672 • Number of events 5 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
0.60%
4/672 • Number of events 4 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum disorder
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Reproductive system and breast disorders
Labour premature
|
0.60%
4/672 • Number of events 4 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Reproductive system and breast disorders
Leukorrhoea
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Reproductive system and breast disorders
Birth premature
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Reproductive system and breast disorders
Genital infection
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Reproductive system and breast disorders
Pre-eclampsia
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Reproductive system and breast disorders
Vaginitis
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Chills
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Skeletal pain
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Renal and urinary disorders
Pyuria
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Renal and urinary disorders
Bacteriuria
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Vascular disorders
Cardiomegaly
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Vascular disorders
Pressure blood increased
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Infections and infestations
Herpes zoster
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal movements decreased
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Cardiac disorders
Palpitation
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Injection site Pain
|
3.1%
21/672 • Number of events 22 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Injection site Swelling
|
0.74%
5/672 • Number of events 5 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Injection site Mass
|
0.45%
3/672 • Number of events 3 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Injection site Erythema
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Injection site Tenderness
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Injection site Reaction
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.45%
3/672 • Number of events 3 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.60%
4/672 • Number of events 4 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Fever
|
0.45%
3/672 • Number of events 3 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
General disorders
Fatigue
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.45%
3/672 • Number of events 3 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.30%
2/672 • Number of events 2 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Infections and infestations
Pharyngitis
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
|
Nervous system disorders
Headache
|
0.15%
1/672 • Number of events 1 • AE(s) and SAE(s) were reported during the 6-Year Surveillance Period follow-up period after vaccination.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place