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

GlaxoSmithKline

Overview

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.

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

Conditions

Human Papillomavirus Infection

Interventions

Cervarix data collectionOTHER

Safety monitoring: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact.

Data CollectionOTHER

All adverse events will be recorded by diary card, follow-up visit or telephone contact.

Eligibility

Sex: FEMALEMin age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Occurrence of solicited local adverse events (AEs).

Time frame: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.

Occurrence of solicited general AEs.

Time frame: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.

Occurrence of unsolicited AEs.

Time frame: 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.

Time frame: Throughout the PMS study period (up to six months after the last dose of Cervarix).

Occurrence of potential Immune-Mediated Diseases (pIMDs).

Time frame: Throughout the PMS study period (up to six months after the last dose of Cervarix).

Occurrence of Medically Significant Condition (MSCs).

Time frame: Throughout the PMS study period (up to six months after the last dose of Cervarix).

Data from ClinicalTrials.gov

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