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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Papillomavirus

Treatments: Biological: Cervarix.; Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01101542

112485

Details and patient eligibility

About

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).

Enrollment: 3,091 patients

Sex: Female

Ages: 10 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

3,091 participants in 1 patient group

Cervarix 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.

Treatment:

Biological: Cervarix.

Other: Data collection