Trials / Completed
CompletedNCT00661713
Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules
A Phase 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 1,631 (actual)
- Sponsor
- Novartis Vaccines · Industry
- Sex
- All
- Age
- 11 Years – 17 Years
- Healthy volunteers
- Accepted
Summary
The proposed study is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rMenB+OMV NZ | |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2010-04-01
- Completion
- 2010-12-01
- First posted
- 2008-04-18
- Last updated
- 2019-03-20
- Results posted
- 2015-11-04
Locations
10 sites across 1 country: Chile
Source: ClinicalTrials.gov record NCT00661713. Inclusion in this directory is not an endorsement.