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

Withdrawn

• Conditions: Human Papillomavirus Infection
• Interventions: Other: Cervarix data collection; Other: Data Collection

• Registration Number: NCT01551537
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-12
• Study Start: 2013-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-05
• Last Update Posted: 2013-09-09
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort Group	Cervarix data collection	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.
Cohort Group	Data Collection	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of solicited local adverse events (AEs).	During the 7-day period (Days 0-6) following any dose of Cervarix and overall.
Occurrence of solicited general AEs.	During the 7-day period (Days 0-6) following any dose of Cervarix and overall.
Occurrence of unsolicited AEs.	During the 30-day period (Days 0-29) following any dose of Cervarix and overall.
Occurrence of any Serious adverse events (SAEs) and SAE(s) causally related to vaccination.	Throughout the PMS study period (up to six months after the last dose of Cervarix).
Occurrence of potential Immune-Mediated Diseases (pIMDs).	Throughout the PMS study period (up to six months after the last dose of Cervarix).
Occurrence of Medically Significant Condition (MSCs).	Throughout the PMS study period (up to six months after the last dose of Cervarix).