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Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (Menveo) Vaccination in Children 2 Through 10 Years of Age
The purpose of this study is to summarize the occurrence of incident serious medically attended events and events of interest up to 1 year following MenACWY-CRM vaccination administered as part of routine clinical care. This US FDA post-marketing commitment study is an open-label, descriptive, epidemiological safety surveillance study of MenACWY-CRM vaccine in subjects 2 to 10 years of age within a large US Healthcare Maintenance Organization. The 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 | 393 |
| Start date | 2011-09 |
| Completion | 2015-07 |
Conditions
- Meningococcal Disease
Interventions
- MenACWY-CRM
Primary outcomes
- Timing relative to vaccination date (mean days (SD)) for all serious medically attended events and events of interest — Observational period of 1 year following date of vaccination of that individual.
- Frequency (n, %) for all serious medically attended events and events of interest — Observational period of 1 year following date of vaccination of that individual.
- Incidence (n per person years, 95% CI) for all serious medically attended events and events of interest — Observational period of 1 year following date of vaccination of that individual.
Countries
United States