Spots Global Cancer Trial Database for Post-marketing Surveillance of GSK Biologicals' Cervarix™ When Administered to Healthy Females in Sri Lanka

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Trial Identification

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

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

Study ID: NCT01551537

Conditions

Human Papillomavirus Infection

Interventions

Cervarix data collection

Data Collection

Study Description

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.