Trials / Completed
CompletedNCT01627561
Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 4 Years – 6 Years
- Healthy volunteers
- Accepted
Summary
The current study evaluates the immunogenicity and safety in 4-6 years old female subjects (experimental group) receiving Cervarix according to a 2-dose schedule (Month 0, 6), as compared to 4-6 years old female subjects (control group) receiving sequentially Priorix (Month 0) and Infanrix (Month 6) vaccines.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Cervarix | 2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6. |
| BIOLOGICAL | Priorix | 1 dose administered intramuscularly in the deltoid muscle of the left arm at Day 0. |
| BIOLOGICAL | Infanrix | 1 dose administered intramuscularly in the deltoid muscle of the left arm at Month 6. |
Timeline
- Start date
- 2012-10-15
- Primary completion
- 2014-04-23
- Completion
- 2016-10-06
- First posted
- 2012-06-26
- Last updated
- 2020-04-10
- Results posted
- 2015-05-08
Locations
4 sites across 3 countries: Colombia, Mexico, Panama
Source: ClinicalTrials.gov record NCT01627561. Inclusion in this directory is not an endorsement.