CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)biological
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/NCT00549900
NCT00549900Phase 1Completed
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Safety and Immunogenicity Study of the HPV Vaccine (GSK-580299) in Healthy, Chinese, Female Subjects

GlaxoSmithKline·interventional·Posted Oct 26, 2007·Updated Jul 20, 2018

In Brief

A Phase 1 clinical trial evaluating GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine) for Infections, Papillomavirus. Completed, enrolled 30 participants across 1 site.

Detailed Summary

A phase I, open label, single-centre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM), administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female subjects aged 15 - 45 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Papillomavirus
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 26, 2007
Enrollment StartDec 2, 2007
Primary CompletionJul 12, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.7 years ago

Interventions

GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)biological

Intramuscular injection, 3 doses