NCT01551537

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 10 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-03-12
• Last updated: 2013-09-09