Post-marketing Surveillance of GSK Biologicals' Cervarix™ When Administered to Healthy Females in Sri Lanka

GlaxoSmithKline (GSK)

Status: Withdrawn

Conditions: Human Papillomavirus Infection

Treatments: Other: Cervarix data collection; Other: Data Collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01551537

113763

Details and patient eligibility

About

This PMS study aims to collect safety and reactogenicity data of Cervarix in the local population as per the licensing requirement of the Sri Lankan regulatory authority.

Full description

Subjects who received one or two doses of Cervarix prior to the start of this PMS study can also be enrolled in the study. These subjects would receive either 2 doses or 1 dose respectively after being enrolled in the study.

Since there is lack of clarity regarding the PMS study requirement (both from Regulatory agency and Ethics Committee), it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency. The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements.

Sex: Female

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that they and/or their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.
• A female aged 10 years and above at the time of the first vaccination.
• Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent(s)/LAR(s) of the subject and informed assent must be obtained from the subject. Where subject/subject's parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness.
• Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified as per the investigator's clinical judgement.

Exclusion criteria

• Subjects with contraindication according to the locally approved PI.
• Child in care.
• Previous administration of more than two doses of Cervarix.
• Previous vaccination with a HPV vaccine other than Cervarix.
• Planned administration of another HPV vaccine other than Cervarix during the PMS study.

Trial design

0 participants in 1 patient group

Cohort Group

Description:

Healthy females aged 10 years and above will receive 1, 2 or 3 doses of Cervarix as per the Prescribing Information (PI) in Sri Lanka.

Treatment:

Other: Data Collection

Other: Cervarix data collection