Safety of MenACWY-CRM Vaccination in Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 11 - 21 |
| Updated: | 3/1/2014 |
| Start Date: | September 2011 |
| End Date: | January 2015 |
| Contact: | Novartis Drug Information Services |
| Phone: | +1 800 244 7668 |
A Phase IV Study to Assess the Safety of Menveo Vaccine Being Used by HMO Subjects Aged 11-21 Years of Age
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.
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.
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.
Inclusion Criteria:
1. Enrolled in the HMO for at least 6 months prior to vaccination
2. Between the ages of 11 and 21 years (inclusive - i.e. has not reached their 22nd
birthday) at the time of the vaccination.
3. Received the vaccine during the study period
Exclusion Criteria:
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