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

Human Papillomavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01551537
• Other study ID #: 113763
• Status: Withdrawn
• Phase: N/A
• First received: March 8, 2012
• Last updated: September 5, 2013
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: September 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sri Lanka: Cosmetics, Devices and Drug Regulatory Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of solicited local adverse events (AEs).		During the 7-day period (Days 0-6) following any dose of Cervarix and overall.	No
Primary	Occurrence of solicited general AEs.		During the 7-day period (Days 0-6) following any dose of Cervarix and overall.	No
Primary	Occurrence of unsolicited AEs.		During the 30-day period (Days 0-29) following any dose of Cervarix and overall.	No
Primary	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).	No
Primary	Occurrence of potential Immune-Mediated Diseases (pIMDs).		Throughout the PMS study period (up to six months after the last dose of Cervarix).	No
Primary	Occurrence of Medically Significant Condition (MSCs).		Throughout the PMS study period (up to six months after the last dose of Cervarix).	No