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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: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01190189 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 137 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
Interventions
- BIOLOGICAL GSK580299 (Cervarix)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2011-04-01 |
| Est. Completion | 2017-11-23 |
| Phase | Phase 3 |
What the finished NCT01190189 record still lists
NCT01190189 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which GSK580299 (Cervarix) is the first listed.
NCT01190189 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01190189's enrollment target sits among peer trials
137 1580th of 2000 higher than 421 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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