Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervarix. | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance). |
| 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. | During the 30-day period (Day 0 to Day 29) following any vaccination (During the 4th year of surveillance). |
| 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. | During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance). |
| 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. |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
Healthy female subjects aged between and including 10 to 25 years who receive Cervarix® according to the current practice of Korean doctors.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Busan | 602-702 | South Korea | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28266092 | Derived | Kim CJ, Song R, Chen J, Tavares Da Silva F, Gopala KB, Kim JH, Bi D, Park JS. Six-year multi-centre, observational, post-marketing surveillance of the safety of the HPV-16/18 AS04-adjuvanted vaccine in women aged 10-25 years in Korea. Pharmacoepidemiol Drug Saf. 2017 Jul;26(7):837-842. doi: 10.1002/pds.4175. Epub 2017 Mar 7. |
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | Subjects who 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 3 Surveillance Period |
|
| |||||||||||||||||||||
| Year 4 Surveillance Period |
| ||||||||||||||||||||||
| Year 5 Surveillance Period |
| ||||||||||||||||||||||
| Year 6 Surveillance Period |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The baseline measure data here corresponds to Year 3 of surveillance. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented. | Posted | Number | Subjects | During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance). |
|
Unsolicited AEs: During the 30-day period (Days 0-29) following any vaccination; SAEs: Throughout the PMS study period (up to one month after the third vaccine dose)
Only adverse events with a frequency of over 5% were listed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cervarix Group | Subjects enrolled for surveillance Year 6, who 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exostosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
Not provided
Not provided
Not provided
Not provided
Not provided
| Data collection | Other | All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards. |
|
| During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th year of surveillance). |
| 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. | 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) |
| 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. | During the 30-day period (Day 0 to Day 29) following any vaccination (During the 5th year of surveillance). |
| 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. | During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance). |
| 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. | During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 5th year of surveillance). |
| 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. | During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance). |
| 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. | 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) |
| Seoul |
| 138-736 |
| South Korea |
|
|
|
A total of 105 participants were included in the Year 3 surveillance.
| Mean |
| Standard Deviation |
| Years |
|
| Age, Continuous | The baseline measure data here corresponds to Year 4 of surveillance. | A total of 569 participants were included in the Year 4 surveillance. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Year 5 of surveillance. | A total of 809 participants were included in the Year 5 surveillance. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Year 6 of surveillance. | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 3 of surveillance. | A total of 105 participants were included in the Year 3 surveillance. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 4 of surveillance. | A total of 569 participants were included in the Year 4 surveillance. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 5 of surveillance. | A total of 809 participants were included in the Year 5 surveillance. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 6 of surveillance. | Count of Participants | Participants |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented. | Posted | Number | Subjects | During the 30-day period (Day 0 to Day 29) following any vaccination (During the 4th year of surveillance). |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented. | Posted | Number | Subjects | During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance). |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented. | Posted | Number | Subjects | During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th year of surveillance). |
|
|
|
| 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. | *Note: the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority. | Posted | 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) |
|
|
| 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. | Posted | Number | Subjects | During the 30-day period (Day 0 to Day 29) following any vaccination (During the 5th year of surveillance). |
|
|
|
| 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. | Posted | Number | Subjects | During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance). |
|
|
|
| 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. | Posted | Number | Subjects | During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 5th year of surveillance). |
|
|
|
| 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. | Posted | Number | Subjects | During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance). |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented. | Posted | Number | Subjects | 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) |
|
|
|
| 3 |
| 3,091 |
| 322 |
| 3,091 |
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tonsillitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Title | Measurements |
|---|---|
|