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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3091 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-01

Study Completion Date

2014-02-20

Brief Summary

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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).

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WITHDRAWN

Detailed Description

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Conditions

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Infections, Papillomavirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cervarix.

Intervention Type 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.

Data collection

Intervention Type OTHER

All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards.

Interventions

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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.

Intervention Type BIOLOGICAL

Data collection

All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes