Safety Surveillance of MenACWY-CRM Vaccine in Children

Meningococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452438
• Other study ID #: V59_54OB
• Status: Completed
• Phase: N/A
• First received: September 29, 2011
• Last updated: August 5, 2015
• Start date: September 2011
• Est. completion date: July 2015

Study information

• Verified date: August 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

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:

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	Kaiser Permanente South California	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	Frequency (n, %) for all serious medically attended events and events of interest		Observational period of 1 year following date of vaccination of that individual.	No
Primary	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.	No