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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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.
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: Seizure, Aseptic meningitis, Bell's Palsy, Multiple Sclerosis, Guillain-Barre Syndrome, Acute disseminated encephalomyelitis, Cerebellar ataxia, Transverse myelitis, Brachial Neuritis, Hashimoto's disease, Systemic Lupus Erythematosis, Henoch Schonlein Purpura, New Onset Juvenile 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, Suicide attempt.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenACYW-CRM vaccinated adolescents | All adolescent recipients of MenACYW-CRM vaccines during the study period. Among these, adolescents who have additionally experienced an event of interest within the 1-year observation period following vaccination will be included in the self-controlled case series. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenACWY-CRM | Biological | MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency (n,%) of each EOI is calculated. | Observational period of 1 year following date of vaccination of that individual. | |
| Incidence (n/person yrs) of each EOI is calculated. | Observational period of 1 year following date of vaccination of that individual. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is selected from the Health Maintenance Organization population of the Kaiser Permanente Southern California (KPSC) HMO in Pasadena, CA, USA.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Medical Center Campus, 10800 Magnolia Ave | Riverside | California | 92505 | United States | ||
| San Diego Medical Center Campus, 4647 Zion Ave 92120 |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C556088 | MenACWY-CRM vaccine |
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| San Diego |
| California |
| 92120 |
| United States |
| Fontana Medical Center Campus | Valley Annex, 16994 E. Valley Blvd., Fontana | California | 92335 | United States |
| D007239 | Infections |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |