Safety Surveillance of MenACWY-CRM Vaccine in Children

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Meningococcal Disease

Intervention / Treatment
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* Biological: MenACWY-CRM


Participation Criteria
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Eligibility Criteria
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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: None

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MenACYW-CRM vaccinated children<br>All children between the age of 2 to 10 years old who have received of MenACYW-CRM vaccine during the study period. | Biological: MenACWY-CRM<br>* MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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observational, MenACYW-CRM, serogroup A, B, Y, W, meningococcal meningitis, meningococcal vaccines, safety, post-marketing, children