Safety Surveillance of MenACWY-CRM Vaccine in Children

Completed

Conditions studied: Meningococcal Disease

In brief

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.

Key facts

Study ID

NCT01452438

Run by

Novartis Vaccines

People needed

393

Starts

2011-09-01

Expected to finish

2015-07-01

Last updated by the study team

2015-08-06

Who can join

Age: 2 and older, up to 10. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• None

Where it is running

• Kaiser Permanente South California — Pasadena, California, United States

Full record on ClinicalTrials.gov

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