Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents
Phase 2
Completed
- Conditions
- Meningococcal Disease
- Registration Number
- NCT00297817
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
Inclusion Criteria
- Healthy Adolescents between and including 11-18 years of age, who provide written informed consent.
Exclusion Criteria
- Previous or suspected disease caused by N. meningitidis; or previous immunization with a serogroup B meningococcal vaccine; Any acute, chronic or progressive disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents 1 month after completion of immunization schedule
- Secondary Outcome Measures
Name Time Method Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents 6 months after completion of immunization schedule