Safety Surveillance of MenACWY-CRM Vaccine in Children

Completed

• Conditions: Meningococcal Disease
• Interventions: Biological: MenACWY-CRM

• Registration Number: NCT01452438
• Lead Sponsor: Novartis Vaccines

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.

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-14
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 393

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.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Kaiser Permanente South California; 🇺🇸 Pasadena, California, United States