Infections, Papillomavirus
Conditions
Keywords
Post-marketing surveillance, Human papillomavirus, Korea, Safety, Prescribing Information
Brief summary
This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs Administration (KFDA).
Interventions
BIOLOGICALCervarix.
Subjects will receive three doses of the Cervarix vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in routine clinical practice settings.
OTHERData collection
All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Female subjects aged between and including, 10 to 25 years at the time of the first vaccination. * Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for vaccination visits etc) should be enrolled in the PMS. * Written informed consent obtained from the subject or the subjects' parent/ guardian. * Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per the investigator's clinical judgement. * Subjects with no contraindication according to the local approved prescribing information. * No previous administration of an HPV vaccine other than Cervarix®. * No previous administration of more than two doses of Cervarix®. * No planned administration of an HPV vaccine other than Cervarix® during the PMS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance). | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. | During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
| Number of Subjects With Medically Significant Conditions. | During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd, 4th, 5th and 6th year of surveillance) | \*Note: For Surveillance Year 3 the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority. |
Countries
South Korea
Participant flow
Pre-assignment details
As per study protocol, subjects who had received 1 or 2 doses of Cervarix vaccine prior to the start of the Post-Marketing Surveillance Study (PMS) could also be enrolled. A total of 3091 participants were enrolled in the study, 105 were available for Year 3 Surveillance and 569 were available for Year 4 Surveillance.
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose. | 3,091 |
| Total | 3,091 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Year 3 Surveillance Period | Lost to Follow-up | 7 |
| Year 3 Surveillance Period | Withdrawal by Subject | 4 |
| Year 4 Surveillance Period | Other | 287 |
| Year 5 Surveillance Period | Lost to Follow-up | 140 |
| Year 5 Surveillance Period | Pregnancy | 1 |
| Year 6 Surveillance Period | Lost to Follow-up | 986 |
| Year 6 Surveillance Period | Pregnancy | 1 |
| Year 6 Surveillance Period | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Cervarix Group |
|---|---|
| Age, Continuous | 20.5 Years STANDARD_DEVIATION 3.82 |
| Sex: Female, Male Female | 3091 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 322 / 3,091 |
| serious Total, serious adverse events | 3 / 3,091 |
Outcome results
Primary
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 5th year of surveillance).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. | Any SAEs | 2 Subjects |
| Cervarix Group | Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. | Related SAEs | 0 Subjects |
Primary
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance).
Population: The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. | Any SAEs | 0 Subjects |
| Cervarix Group | Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. | Related SAEs | 0 Subjects |
Primary
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Note: Results for the 5th and 6th year of surveillance will be added when they become available.
Time frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th year of surveillance).
Population: The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. | 2 Subjects |
Primary
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. | Any SAEs | 3 Subjects |
| Cervarix Group | Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. | Related SAEs | 0 Subjects |
Primary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 620 Subjects |
Primary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance).
Population: The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 30 Subjects |
Primary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Note: Results for the 5th and 6th year of surveillance will be added when they become available.
Time frame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 4th year of surveillance).
Population: The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 88 Subjects |
Primary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 5th year of surveillance).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 214 Subjects |
Primary
Number of Subjects With Medically Significant Conditions.
MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th, 5th and 6th year of surveillance)
Population: The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Medically Significant Conditions. | Subjects with any MSCs, Year 4 (N=569) | 27 Subjects |
| Cervarix Group | Number of Subjects With Medically Significant Conditions. | Subjects with any MSCs, Year 5 (N=809) | 44 Subjects |
| Cervarix Group | Number of Subjects With Medically Significant Conditions. | Subjects with any MSCs, Year 6 (N=3091) | 135 Subjects |
Primary
Number of Subjects With Medically Significant Conditions.
\*Note: For Surveillance Year 3 the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.
Time frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd, 4th, 5th and 6th year of surveillance)
Population: \*Note: the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.