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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Neoplasms, Rectal

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03671369

208710

Details and patient eligibility

About

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.

Enrollment: 670 patients

Sex: All

Ages: 9 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

670 participants in 1 patient group

Cervarix Group

Description:

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.

Treatment:

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