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
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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