Safety Surveillance of MenACWY-CRM Vaccine in Children
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 2 - 10 |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | July 2015 |
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.
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.
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
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
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:
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