Safety of MenACWY-CRM Vaccination in Adolescents

Sponsor

Novartis Vaccines (Industry)

Overall Status

Completed

CT.gov ID

NCT01452464

Collaborator

Novartis (Industry)

55,397

Enrollment

Locations

Duration (Months)

18465.7

Patients Per Site

450

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Meningococcal Disease	Biological: MenACWY-CRM

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: 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.

Study Design

Study Type:

Observational

Actual Enrollment :

55397 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Phase IV Study to Assess the Safety of Menveo Vaccine Being Used by HMO Subjects Aged 11-21 Years of Age

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

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.

Biological: MenACWY-CRM

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

Outcome Measures

Primary Outcome Measures

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.]

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Enrolled in the HMO for at least 6 months prior to vaccination
Between the ages of 11 and 21 years (inclusive - i.e. has not reached their 22nd birthday) at the time of the vaccination.
Received the vaccine during the study period

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riverside Medical Center Campus, 10800 Magnolia Ave	Riverside	California	United States	92505
2	San Diego Medical Center Campus, 4647 Zion Ave 92120	San Diego	California	United States	92120
3	Fontana Medical Center Campus	Valley Annex, 16994 E. Valley Blvd., Fontana	California	United States	92335