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

NCT ID: NCT01551537

Last Updated: 2013-09-09

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-04-30

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.

Conditions

Human Papillomavirus Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cervarix data collection

Intervention Type: OTHER

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

Data Collection

Intervention Type: OTHER

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

Interventions

Cervarix data collection

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

Intervention Type: OTHER

Data Collection

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

113763

Identifier Type: -

Identifier Source: org_study_id