CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,091 enrolled
Drug / intervention
Cervarix. +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01101542
NCT01101542N/ACompleted
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Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix® When Administered to Healthy Females According to the Prescribing Information in Korea

GlaxoSmithKline·observational·Posted Apr 12, 2010·Updated Jul 23, 2018

In Brief

An observational study evaluating Cervarix. and Data collection for Infections, Papillomavirus. Completed, enrolled 3,091 participants across 2 sites.

Detailed Summary

This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs Administration (KFDA).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Papillomavirus
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 12, 2010
Enrollment StartJul 1, 2010
Primary CompletionFeb 20, 2014
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 16.2 years ago

Interventions

Cervarix.biological

Subjects will receive three doses of the Cervarix vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in routine clinical practice settings.

Data collectionother

All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards.