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A Phase IV Study to Assess the Safety of Menveo Vaccine Being Used by HMO Subjects Aged 11-21 Years of Age
The purpose of this US FDA post-marketing commitment study is to evaluate the safety of MenACWY-CRM among 50.000 vaccinated adolescents within a large US Healthcare Maintenance Organization who received MenACWY-CRM vaccination as part of their routine clinical care. The pre-specified 26 events of interest are events commonly evaluated in vaccine safety studies and include certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All events are collected retrospectively.
Details
| Lead sponsor | Novartis Vaccines |
|---|---|
| Status | COMPLETED |
| Enrolment | 55397 |
| Start date | 2011-09 |
| Completion | 2015-02 |
Conditions
- Meningococcal Disease
Interventions
- MenACWY-CRM
Primary outcomes
- Relative incidence (RI) for an Event of Interest (EOI) is calculated using the self controlled case series method. RI is the ratio of the incidence of an EOI in a pre-specified, event-specific risk window relative to the incidence in the control period. — Observational period of 1 year following date of vaccination of that individual.
Countries
United States