A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

670 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-02

Study Completion Date

2020-12-01

Brief Summary

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The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30 days after each vaccination dose, when administered according to the approved prescribing information (PI) in Korea in a real health care setting over a period of 4 years.

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Detailed Description

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Conditions

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Neoplasms, Rectal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cervarix Group

The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.

Safety data collection (following routine vaccination) by a continuous surveillance method.

Intervention Type OTHER

This study assesses the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine in terms of frequency and intensity of adverse events (AEs) and serious adverse events (SAEs) when administered routinely in male and female subjects aged between 9 and 25 years, according to the approved Prescribing Information in Korea.

All AEs reported during the 30-day post-vaccination follow-up period (Day 1 to Day 30) and all SAEs reported through the study period from dose 1 up to 30 days after the last dose administered during the post-marketing surveillance (PMS) were collected as part of safety data in this PMS.

Interventions

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Safety data collection (following routine vaccination) by a continuous surveillance method.

This study assesses the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine in terms of frequency and intensity of adverse events (AEs) and serious adverse events (SAEs) when administered routinely in male and female subjects aged between 9 and 25 years, according to the approved Prescribing Information in Korea.

All AEs reported during the 30-day post-vaccination follow-up period (Day 1 to Day 30) and all SAEs reported through the study period from dose 1 up to 30 days after the last dose administered during the post-marketing surveillance (PMS) were collected as part of safety data in this PMS.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject or/and subjects whose parent(s)/Legally Acceptable Representative(s) \[LAR(s)\], in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Korean male or female subjects aged 9-25 years who are eligible for the series of Cervarix according to the locally approved PI.
* Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.

Exclusion Criteria

* At the time of PMS entry, the contraindications and precautions of use indicated in the locally approved PI. PI should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved PI must be implemented immediately.
* Subjects who had previous administration of a HPV vaccine other than Cervarix will not be enrolled into the study.
* Subjects who are not eligible for vaccination with Cervarix according to the medical judgement of physician.
* Child in care.

Minimum Eligible Age

9 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes