Trials / Completed
CompletedNCT01381575
Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,447 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 9 Years – 25 Years
- Healthy volunteers
- Accepted
Summary
This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule (0,1,6 months) in 15-25 year old females.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSK Biologicals' HPV vaccine 580299 | Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly. |
Timeline
- Start date
- 2011-06-29
- Primary completion
- 2012-06-28
- Completion
- 2014-11-13
- First posted
- 2011-06-27
- Last updated
- 2020-06-09
- Results posted
- 2013-12-05
Locations
33 sites across 5 countries: Canada, Germany, Italy, Taiwan, Thailand
Source: ClinicalTrials.gov record NCT01381575. Inclusion in this directory is not an endorsement.