NCT01452438

Safety Surveillance of MenACWY-CRM Vaccine in Children

Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (Menveo) Vaccination in Children 2 Through 10 Years of Age

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 393 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Accepted

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

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM	MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records.

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2011-10-14
• Last updated: 2015-08-06

Locations

1 site across 1 country: United States