Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (Menveo) Vaccination in Children 2 Through 10 Years of Age
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Meningococcal Disease
- Sponsor
- Novartis Vaccines
- Enrollment
- 393
- Locations
- 1
- Primary Endpoint
- Frequency (n, %) for all serious medically attended events and events of interest
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
This is an observational study, vaccines administration and data that is collected is only as part of routine clinical care. Vaccinated subjects are not actively recruited. Events of Interest: Diabetes Mellitus, Rheumatoid arthritis, Idiopathic Thrombocytopenic Purpura, Iridocyclitis, Acute glomerulonephritis, Nephrotic syndrome, Grave's disease, Autoimmune hemolytic anemia, Myasthenia Gravis, New onset asthma, Allergic urticaria, Anaphylaxis, Meningococcal Disease, Intentional Injury
Investigators
Eligibility Criteria
Inclusion Criteria
- •Registered with the HMO for at least 6 months prior to vaccination.
- •Between the ages of 2 and 10 years (inclusive - i.e. has not reached their 11th birthday) at the time of the vaccination.
- •Received any MenACWY-CRM vaccination during the vaccination period at the participating centers.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Frequency (n, %) for all serious medically attended events and events of interest
Time Frame: 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
Time Frame: Observational period of 1 year following date of vaccination of that individual.
Timing relative to vaccination date (mean days (SD)) for all serious medically attended events and events of interest
Time Frame: Observational period of 1 year following date of vaccination of that individual.