Trials / Completed
CompletedNCT01755689
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine 134612 With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults at 9-25 Years of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,300 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 9 Years – 25 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix co-administered with Boostrix.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Meningococcal vaccine GSK134612 | One dose administered intramuscularly (IM) in the deltoid of the right arm. |
| BIOLOGICAL | Cervarix® | Three doses administered intramuscularly (IM) in the deltoid of the left arm. |
| BIOLOGICAL | Boostrix® | One dose administered intramuscularly (IM) in the deltoid of the left arm. |
Timeline
- Start date
- 2013-01-11
- Primary completion
- 2014-04-29
- Completion
- 2014-04-29
- First posted
- 2012-12-24
- Last updated
- 2018-07-03
- Results posted
- 2018-07-03
Locations
3 sites across 3 countries: Dominican Republic, Estonia, Thailand
Source: ClinicalTrials.gov record NCT01755689. Inclusion in this directory is not an endorsement.