Post-marketing Surveillance of GSK Biologicals' Cervarix™ When Administered to Healthy Females in Sri Lanka
|Human Papillomavirus Infection||Other: Cervarix data collection Other: Data Collection|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- 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). ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551537
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|