Safety Surveillance of MenACWY-CRM Vaccine in Children

Sponsor

Novartis Vaccines (Industry)

Overall Status

Completed

CT.gov ID

NCT01452438

Collaborator

(none)

393

Enrollment

Location

Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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: 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

Study Design

Study Type:

Observational

Actual Enrollment :

393 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
MenACYW-CRM vaccinated children All children between the age of 2 to 10 years old who have received of MenACYW-CRM vaccine during the study period.	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 children

All children between the age of 2 to 10 years old who have received of MenACYW-CRM vaccine during the study period.

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

Timing relative to vaccination date (mean days (SD)) for all serious medically attended events and events of interest [Observational period of 1 year following date of vaccination of that individual.]
Frequency (n, %) for all serious medically attended events and events of interest [Observational period of 1 year following date of vaccination of that individual.]
Incidence (n per person years, 95% CI) for all serious medically attended events and events of interest [Observational period of 1 year following date of vaccination of that individual.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Registered with the HMO for at least 6 months prior to vaccination.
Between the ages of 2 and 10 years (inclusive - i.e. has not reached their 11th birthday) at the time of the vaccination.
Received any MenACWY-CRM vaccination during the vaccination period at the participating centers.