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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01452464
Other study ID # V59_34OB
Secondary ID
Status Completed
Phase N/A
First received September 29, 2011
Last updated February 25, 2015
Start date September 2011
Est. completion date February 2015

Study information

Verified date February 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.


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: 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.


Recruitment information / eligibility

Status Completed
Enrollment 55397
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 21 Years
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Biological:
MenACWY-CRM
MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records.

Locations

Country Name City State
United States Riverside Medical Center Campus, 10800 Magnolia Ave Riverside California
United States San Diego Medical Center Campus, 4647 Zion Ave 92120 San Diego California
United States Fontana Medical Center Campus Valley Annex, 16994 E. Valley Blvd., Fontana California

Sponsors (2)

Lead Sponsor Collaborator
Novartis Vaccines Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Secondary Frequency (n,%) of each EOI is calculated. Observational period of 1 year following date of vaccination of that individual. No
Secondary Incidence (n/person yrs) of each EOI is calculated. Observational period of 1 year following date of vaccination of that individual. No
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