Diphtheria-Tetanus-acellular Pertussis Vaccines
Conditions
Keywords
Korea, Post-marketing surveillance, Boostrix, Prescribing information, Safety
Brief summary
The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.
Detailed description
Protocol amendment 3 rationale was as follows: * Age for analysis set is specified. * Subjects with pregnancy will be analyzed by their pregnancy status before/after vaccination. * Pregnancy notifications must be done within 2 weeks
Interventions
BIOLOGICALBoostrix
Single intramuscular injection
Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Written or signed informed consent obtained from the subject/ subject's parent(s)/Legally Acceptable Representative(s) of the child. Korean male or female subjects who were recently vaccinated or eligible to receive Boostrix according to the locally approved Prescribing Information.
Exclusion criteria
* Those who are not eligible for vaccination according to the local Prescribing Information. * Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Unexpected Adverse Events (AEs) | During the 30-day (Day 0 - Day 29) follow-up period after vaccination. | Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea. |
| Number of Expected AEs. | During the 30-day (Day 0 - Day 29) follow-up period after vaccination. | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the 30-day (Day 0 - Day 29) follow-up period after vaccination. | 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. |
Countries
South Korea
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 672 |
| Total | 672 |
Baseline characteristics
| Characteristic | Boostrix Group |
|---|---|
| Age, Continuous | 44.38 Years STANDARD_DEVIATION 14.76 |
| Race/Ethnicity, Customized Korean | 672 Participants |
| Sex: Female, Male Female | 451 Participants |
| Sex: Female, Male Male | 221 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 672 |
| other Total, other adverse events | 90 / 672 |
| serious Total, serious adverse events | 6 / 672 |
Outcome results
Primary
Number of Expected AEs.
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boostrix Group | Number of Expected AEs. | 59 Events |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |
Primary
Number of Unexpected Adverse Events (AEs)
Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boostrix Group | Number of Unexpected Adverse Events (AEs) | 65 Events |