Trials / Completed
CompletedNCT01249365
The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 199 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 26 Years
- Healthy volunteers
- Accepted
Summary
This extension study is designed to assess the safety of GSK Biological's 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.
Detailed description
This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to the update of 1 of the primary outcome measures and following Protocol Amendment 2, January 2011, leading to the removal of one of the exclusion criteria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSK580299 (Cervarix) | 3-dose schedule intramuscularly vaccination |
Timeline
- Start date
- 2011-01-24
- Primary completion
- 2017-01-10
- Completion
- 2017-01-10
- First posted
- 2010-11-29
- Last updated
- 2019-11-13
- Results posted
- 2018-07-16
Locations
15 sites across 4 countries: Australia, Portugal, Russia, Singapore
Source: ClinicalTrials.gov record NCT01249365. Inclusion in this directory is not an endorsement.