Neoplasms, Rectal
Conditions
Keywords
Human Papillomavirus Vaccine, Adverse events after vaccination, Safety, Serious adverse events after vaccination
Brief summary
The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30 days after each vaccination dose, when administered according to the approved prescribing information (PI) in Korea in a real health care setting over a period of 4 years.
Interventions
OTHERSafety data collection (following routine vaccination) by a continuous surveillance method.
This study assesses the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine in terms of frequency and intensity of adverse events (AEs) and serious adverse events (SAEs) when administered routinely in male and female subjects aged between 9 and 25 years, according to the approved Prescribing Information in Korea. All AEs reported during the 30-day post-vaccination follow-up period (Day 1 to Day 30) and all SAEs reported through the study period from dose 1 up to 30 days after the last dose administered during the post-marketing surveillance (PMS) were collected as part of safety data in this PMS.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
9 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject or/and subjects whose parent(s)/Legally Acceptable Representative(s) \[LAR(s)\], in the opinion of the investigator, can and will comply with the requirements of the protocol. * Korean male or female subjects aged 9-25 years who are eligible for the series of Cervarix according to the locally approved PI. * Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
Exclusion criteria
* At the time of PMS entry, the contraindications and precautions of use indicated in the locally approved PI. PI should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved PI must be implemented immediately. * Subjects who had previous administration of a HPV vaccine other than Cervarix will not be enrolled into the study. * Subjects who are not eligible for vaccination with Cervarix according to the medical judgement of physician. * Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1 | From Day 1 up to 30 days (post dose 1 vaccination) | An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100. |
| Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2 | From Day 1 up to 30 days (post dose 2 vaccination) | An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100. |
| Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3 | From Day 1 up to 30 days (post dose 3 vaccination) | An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100. |
| Number of Participants With AEs by Maximum Intensity Post Dose 1 | From Day 1 up to 30 days (post dose 1 vaccination) | An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement. |
| Number of Participants With AEs by Maximum Intensity Post Dose 2 | From Day 1 up to 30 days (post dose 2 vaccination) | An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement. |
| Number of Participants With AEs by Maximum Intensity Post Dose 3 | From Day 1 up to 30 days (post dose 3 vaccination) | An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement. |
| Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs | From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6) | A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. |
Countries
South Korea
Participant flow
Recruitment details
This study was conducted at 29 centers in Republic of Korea.
Pre-assignment details
Out of 670 subjects enrolled in the study, 1 subject did not receive any vaccine and therefore was not included in any analysis.
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose. | 669 |
| Total | 669 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not willing to be vaccinated | 1 |
| Overall Study | Other | 1 |
| Overall Study | Withdrawal by Subject | 289 |
Baseline characteristics
| Characteristic | Cervarix Group |
|---|---|
| Age, Continuous | 12.92 Years STANDARD_DEVIATION 2.75 |
| Race/Ethnicity, Customized Korean | 664 Participants |
| Race/Ethnicity, Customized Non-Korean | 5 Participants |
| Sex/Gender, Customized Female | 646 Participants |
| Sex/Gender, Customized Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 669 |
| other Total, other adverse events | 144 / 669 |
| serious Total, serious adverse events | 0 / 669 |
Outcome results
Primary
Number of Participants With AEs by Maximum Intensity Post Dose 1
An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.
Time frame: From Day 1 up to 30 days (post dose 1 vaccination)
Population: The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Participants With AEs by Maximum Intensity Post Dose 1 | 0 Participants |
Primary
Number of Participants With AEs by Maximum Intensity Post Dose 2
An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.
Time frame: From Day 1 up to 30 days (post dose 2 vaccination)
Population: The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received two doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Participants With AEs by Maximum Intensity Post Dose 2 | 0 Participants |
Primary
Number of Participants With AEs by Maximum Intensity Post Dose 3
An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.
Time frame: From Day 1 up to 30 days (post dose 3 vaccination)
Population: The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received three doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Participants With AEs by Maximum Intensity Post Dose 3 | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6)
Population: The analysis was performed on the Total Safety cohort, which included all participants who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30 days follow up period after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs | Serious Adverse Events | 0 Participants |
| Cervarix Group | Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs | Fatal Serious Adverse Events | 0 Participants |
Primary
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1
An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.
Time frame: From Day 1 up to 30 days (post dose 1 vaccination)
Population: The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1 | 17.72 Percentage of subjects |
Primary
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2
An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.
Time frame: From Day 1 up to 30 days (post dose 2 vaccination)
Population: The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received two doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2 | 18.77 Percentage of subjects |
Primary
Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3
An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.
Time frame: From Day 1 up to 30 days (post dose 3 vaccination)
Population: The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received three doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3 | 2.86 Percentage of subjects |