Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 10 - 18 |
| Updated: | 9/14/2018 |
| Start Date: | May 2014 |
| End Date: | February 2015 |
A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.
Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single
dose of MenACWY vaccine.
dose of MenACWY vaccine.
Inclusion Criteria:
- Adolescents from 10-18 years of age, generally in good health, and available for all
study visits, who/whose legally acceptable representative has given written informed
consent at the time of enrollment.
- Female subjects of childbearing potential must have a negative urine pregnancy test.
Exclusion Criteria:
- Serious, acute, or chronic illnesses. Previous or suspected disease caused by N.
meningitidis. Previous immunization with any meningococcal vaccine.
- Exposure to individuals with clinically proven meningococcal disease or clinical
bacterial meningitis without further microbiologic characterization.
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