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
Verified date | August 2015 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
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: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente South California | Pasadena | California |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines |
United States,
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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