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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01452438
Other study ID # V59_54OB
Secondary ID
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


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
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