Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 91 for:    cervarix

Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01101542
Recruitment Status : Completed
First Posted : April 12, 2010
Results First Posted : December 19, 2011
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Infections, Papillomavirus
Interventions Biological: Cervarix.
Other: Data collection
Enrollment 3091
Recruitment Details  
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.
Arm/Group Title Cervarix Group
Hide Arm/Group Description 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.
Period Title: Year 3 Surveillance Period
Started 105
Completed 94
Not Completed 11
Reason Not Completed
Lost to Follow-up             7
Withdrawal by Subject             4
Period Title: Year 4 Surveillance Period
Started 569
Completed 282
Not Completed 287
Reason Not Completed
Other             287
Period Title: Year 5 Surveillance Period
Started 809
Completed 668
Not Completed 141
Reason Not Completed
Lost to Follow-up             140
Pregnancy             1
Period Title: Year 6 Surveillance Period
Started 3091
Completed 2100
Not Completed 991
Reason Not Completed
Lost to Follow-up             986
Pregnancy             1
Withdrawal by Subject             4
Arm/Group Title Cervarix Group
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 3091
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants
20.4  (3.72)
[1]
Measure Description: The baseline measure data here corresponds to Year 3 of surveillance.
[2]
Measure Analysis Population Description: A total of 105 participants were included in the Year 3 surveillance.
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 569 participants
20.8  (3.87)
[1]
Measure Description: The baseline measure data here corresponds to Year 4 of surveillance.
[2]
Measure Analysis Population Description: A total of 569 participants were included in the Year 4 surveillance.
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 809 participants
20.9  (3.06)
[1]
Measure Description: The baseline measure data here corresponds to Year 5 of surveillance.
[2]
Measure Analysis Population Description: A total of 809 participants were included in the Year 5 surveillance.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3091 participants
20.5  (3.82)
[1]
Measure Description: The baseline measure data here corresponds to Year 6 of surveillance.
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Female
105
 100.0%
Male
0
   0.0%
[1]
Measure Description: The baseline measure data here corresponds to Year 3 of surveillance.
[2]
Measure Analysis Population Description: A total of 105 participants were included in the Year 3 surveillance.
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 569 participants
Female
569
 100.0%
Male
0
   0.0%
[1]
Measure Description: The baseline measure data here corresponds to Year 4 of surveillance.
[2]
Measure Analysis Population Description: A total of 569 participants were included in the Year 4 surveillance.
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 809 participants
Female
809
 100.0%
Male
0
   0.0%
[1]
Measure Description: The baseline measure data here corresponds to Year 5 of surveillance.
[2]
Measure Analysis Population Description: A total of 809 participants were included in the Year 5 surveillance.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3091 participants
Female
3091
 100.0%
Male
0
   0.0%
[1]
Measure Description: The baseline measure data here corresponds to Year 6 of surveillance.
1.Primary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cervarix Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Subjects
30
2.Primary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Hide Description

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).
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cervarix Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 569
Measure Type: Number
Unit of Measure: Subjects
88
3.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cervarix Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Subjects
Any SAEs 0
Related SAEs 0
4.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
Hide Description

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).
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cervarix Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 569
Measure Type: Number
Unit of Measure: Subjects
2
5.Primary Outcome
Title Number of Subjects With Medically Significant Conditions.
Hide Description *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)
Hide Outcome Measure Data
Hide Analysis Population Description
*Note: the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 809
Measure Type: Number
Unit of Measure: Subjects
214
7.Primary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3091
Measure Type: Number
Unit of Measure: Subjects
620
8.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 809
Measure Type: Number
Unit of Measure: Subjects
Any SAEs 2
Related SAEs 0
9.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3091
Measure Type: Number
Unit of Measure: Subjects
Any SAEs 3
Related SAEs 0
10.Primary Outcome
Title Number of Subjects With Medically Significant Conditions.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cervarix Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3091
Measure Type: Number
Unit of Measure: Subjects
Subjects with any MSCs, Year 4 (N=569) 27
Subjects with any MSCs, Year 5 (N=809) 44
Subjects with any MSCs, Year 6 (N=3091) 135
Time Frame 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)
Adverse Event Reporting Description Only adverse events with a frequency of over 5% were listed.
 
Arm/Group Title Cervarix Group
Hide Arm/Group Description 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.
All-Cause Mortality
Cervarix Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Group
Affected / at Risk (%)
Total   3/3091 (0.10%) 
Gastrointestinal disorders   
Gastroenteritis *  1/3091 (0.03%) 
Musculoskeletal and connective tissue disorders   
Exostosis *  1/3091 (0.03%) 
Respiratory, thoracic and mediastinal disorders   
Tonsillitis *  1/3091 (0.03%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix Group
Affected / at Risk (%)
Total   322/3091 (10.42%) 
General disorders   
Injection site pain   322/3091 (10.42%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01101542     History of Changes
Other Study ID Numbers: 112485
First Submitted: April 8, 2010
First Posted: April 12, 2010
Results First Submitted: November 10, 2011
Results First Posted: December 19, 2011
Last Update Posted: July 23, 2018