Safety of MenACWY-CRM Vaccination in Adolescents

Meningococcal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452464
• Other study ID #: V59_34OB
• 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

• Meningococcal Disease
• Meningococcal Infections

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