CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 6,051 enrolled
Drug / intervention
HPV (Types 16, 18) Vaccine, Adsorbedbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03629886
NCT03629886Phase 4Completed
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Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study

GlaxoSmithKline·interventional·Posted Aug 14, 2018·Updated Mar 15, 2024

In Brief

A Phase 4 clinical trial evaluating HPV (Types 16, 18) Vaccine, Adsorbed for Cervical Intraepithelial Neoplasia. Completed, enrolled 6,051 participants across 4 sites.

Detailed Summary

This study was designed to enable all subjects who received placebo in the HPV-039 study (NCT00779766), to also receive GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed. Safety data in terms of serious adverse events (SAEs), any adverse events (AEs)/SAEs leading to premature discontinuation of the study, potential immune mediated diseases (pIMDs) and pregnancies (and their outcomes) were collected during the study period. In addition, this study assessed the long term protective effect of the vaccine, in an exploratory manner, in terms of rates of HPV-related (vaccine type) incident cervical infection up to approximately 10 years after vaccination in subjects who participated in HPV-039 study (NCT00779766).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Intraepithelial Neoplasia
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 14, 2018
Enrollment StartAug 22, 2018
Primary CompletionFeb 28, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.9 years ago

Interventions

HPV (Types 16, 18) Vaccine, Adsorbedbiological

Three doses of Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed administered intramuscularly in the deltoid region of the upper arm, according to a 0, 1, 6-month schedule.