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

Post-marketing Surveillance (PMS) of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) -16/18 Vaccine, Cervarix™ When Administered to Healthy Females According to the Prescribing Information in Sri Lanka

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.

Study Overview

• Status: Withdrawn
• Conditions: Human Papillomavirus Infection
• Intervention / Treatment: Other: Cervarix data collection; Other: Data Collection

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy females aged 10 years and above who will receive Cervarix as a part of routine practice as per the PI in Sri Lanka.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort Group; 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.	Other: Cervarix data collection; Safety monitoring: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact.; Other: Data Collection; All adverse events will be recorded by diary card, follow-up visit or telephone contact.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: March 8, 2012
• First Submitted That Met QC Criteria: March 8, 2012
• First Posted (Estimate): March 12, 2012

Study Record Updates

• Last Update Posted (Estimate): September 9, 2013
• Last Update Submitted That Met QC Criteria: September 5, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Cervarix; Healthy females; Human papillomavirus vaccine; Sri Lanka; Post-marketing surveillance (PMS)
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Tumor Virus Infections; Papillomavirus Infections
• Other Study ID Numbers: 113763