Trial Outcomes & Findings for Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females (NCT NCT01101542)
NCT ID: NCT01101542
Last Updated: 2018-07-23
Results Overview
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.
COMPLETED
3091 participants
During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance).
2018-07-23
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Year 3 Surveillance Period
STARTED
|
105
|
|
Year 3 Surveillance Period
COMPLETED
|
94
|
|
Year 3 Surveillance Period
NOT COMPLETED
|
11
|
|
Year 4 Surveillance Period
STARTED
|
569
|
|
Year 4 Surveillance Period
COMPLETED
|
282
|
|
Year 4 Surveillance Period
NOT COMPLETED
|
287
|
|
Year 5 Surveillance Period
STARTED
|
809
|
|
Year 5 Surveillance Period
COMPLETED
|
668
|
|
Year 5 Surveillance Period
NOT COMPLETED
|
141
|
|
Year 6 Surveillance Period
STARTED
|
3091
|
|
Year 6 Surveillance Period
COMPLETED
|
2100
|
|
Year 6 Surveillance Period
NOT COMPLETED
|
991
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
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
A total of 105 participants were included in the Year 3 surveillance.
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=3091 Participants
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.
|
|---|---|
|
Age, Continuous
|
20.5 Years
STANDARD_DEVIATION 3.82 • n=3091 Participants
|
|
Sex: Female, Male
Female
|
3091 Participants
n=3091 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=3091 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=105 Participants
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.
|
|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
|
30 Subjects
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=569 Participants
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.
|
|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
|
88 Subjects
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=105 Participants
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.
|
|---|---|
|
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
Any SAEs
|
0 Subjects
|
|
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
Related SAEs
|
0 Subjects
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=569 Participants
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.
|
|---|---|
|
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
|
2 Subjects
|
PRIMARY outcome
Timeframe: 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.
\*Note: For Surveillance Year 3 the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 5th 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.
Outcome measures
| Measure |
Cervarix Group
n=809 Participants
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.
|
|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
|
214 Subjects
|
PRIMARY outcome
Timeframe: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th 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.
Outcome measures
| Measure |
Cervarix Group
n=3091 Participants
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.
|
|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
|
620 Subjects
|
PRIMARY outcome
Timeframe: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 5th 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.
Outcome measures
| Measure |
Cervarix Group
n=809 Participants
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.
|
|---|---|
|
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
Any SAEs
|
2 Subjects
|
|
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
Related SAEs
|
0 Subjects
|
PRIMARY outcome
Timeframe: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th 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.
Outcome measures
| Measure |
Cervarix Group
n=3091 Participants
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.
|
|---|---|
|
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
Any SAEs
|
3 Subjects
|
|
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
Related SAEs
|
0 Subjects
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=3091 Participants
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.
|
|---|---|
|
Number of Subjects With Medically Significant Conditions.
Subjects with any MSCs, Year 4 (N=569)
|
27 Subjects
|
|
Number of Subjects With Medically Significant Conditions.
Subjects with any MSCs, Year 5 (N=809)
|
44 Subjects
|
|
Number of Subjects With Medically Significant Conditions.
Subjects with any MSCs, Year 6 (N=3091)
|
135 Subjects
|
Adverse Events
Cervarix Group
Serious adverse events
| Measure |
Cervarix Group
n=3091 participants at risk
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.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.03%
1/3091 • 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.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.03%
1/3091 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillitis
|
0.03%
1/3091 • 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.
|
Other adverse events
| Measure |
Cervarix Group
n=3091 participants at risk
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.
|
|---|---|
|
General disorders
Injection site pain
|
10.4%
322/3091 • 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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER