An observational study in Human Papillomavirus Infection, sponsored by GlaxoSmithKline. Withdrawn. Open to female participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-09.
Sponsored by GlaxoSmithKline · Observational
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.
496 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
Browse Papillomavirus Infections studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Healthy females aged 10 years and above who will receive Cervarix as a part of routine practice as per the PI in Sri Lanka.
Exclusion Criteria:
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 · Other: Data Collection
Safety monitoring: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact.
All adverse events will be recorded by diary card, follow-up visit or telephone contact.
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).
No study locations are listed for this record.
This study is withdrawn, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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