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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01101542
First received: April 8, 2010
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention
Infections, Papillomavirus
Biological: Cervarix.
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix® When Administered to Healthy Females According to the Prescribing Information in Korea

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance). ] [ Designated as safety issue: No ]
    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 Unsolicited Adverse Events (AEs) [ Time Frame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 4th, 5th and 6th year of surveillance). ] [ Designated as safety issue: No ]

    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.


  • Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. [ Time Frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance). ] [ Designated as safety issue: No ]
    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 Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination. [ 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). ] [ Designated as safety issue: No ]

    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.


  • Number of Subjects With Medically Significant Conditions. [ 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) ] [ Designated as safety issue: No ]
    *Note: the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.


Enrollment: 3091
Study Start Date: July 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Biological: Cervarix.
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.
Other: Data collection
All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards.

  Eligibility

Ages Eligible for Study:   10 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy female subjects aged between and including 10 to 25 years who receive Cervarix® according to the current practice of Korean doctors.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101542

Locations
Korea, Republic of
GSK Investigational Site
Busan, Korea, Republic of, 602-702
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01101542     History of Changes
Other Study ID Numbers: 112485
Study First Received: April 8, 2010
Results First Received: November 10, 2011
Last Updated: May 15, 2014
Health Authority: Korea: Korea Food & Drug Administration

Keywords provided by GlaxoSmithKline:
Post-marketing surveillance
Human papillomavirus
Korea
Safety
Prescribing Information

ClinicalTrials.gov processed this record on October 23, 2014