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NCT01190189 · ClinicalTrials.gov registry record · Phase 3

Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
137
Enrollment target

NCT01190189 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 137 participants.

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The verdict

NCT01190189, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
137 participants
Enrollment target

Study Summary

This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

Interventions

  • BIOLOGICAL GSK580299 (Cervarix)

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2011-04-01
Est. Completion 2017-11-23
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01190189

The ClinicalTrials.gov registry entry for NCT01190189 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which GSK580299 (Cervarix) is the first listed.

NCT01190189 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01190189 about?

NCT01190189 is a clinical study titled "Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study". This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subje...

What is the current status of trial NCT01190189?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 137 participants. The study started on 2011-04-01. Estimated completion is 2017-11-23.

What interventions are being tested in trial NCT01190189?

The interventions under investigation include: GSK580299 (Cervarix) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01190189?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.