Meningococcal Disease Clinical Trial
Official title:
A Phase IV Study to Assess the Safety of Menveo Vaccine Being Used by HMO Subjects Aged 11-21 Years of Age
Verified date | February 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 US FDA post-marketing commitment study is to evaluate the safety of MenACWY-CRM among 50.000 vaccinated adolescents within a large US Healthcare Maintenance Organization who received MenACWY-CRM vaccination as part of their routine clinical care. The pre-specified 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 | 55397 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 11 Years to 21 Years |
Eligibility |
Inclusion Criteria: 1. Enrolled in the HMO for at least 6 months prior to vaccination 2. Between the ages of 11 and 21 years (inclusive - i.e. has not reached their 22nd birthday) at the time of the vaccination. 3. Received the vaccine during the study period Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Riverside Medical Center Campus, 10800 Magnolia Ave | Riverside | California |
United States | San Diego Medical Center Campus, 4647 Zion Ave 92120 | San Diego | California |
United States | Fontana Medical Center Campus | Valley Annex, 16994 E. Valley Blvd., Fontana | California |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines | Novartis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relative incidence (RI) for an Event of Interest (EOI) is calculated using the self controlled case series method. RI is the ratio of the incidence of an EOI in a pre-specified, event-specific risk window relative to the incidence in the control period. | Observational period of 1 year following date of vaccination of that individual. | No | |
Secondary | Frequency (n,%) of each EOI is calculated. | Observational period of 1 year following date of vaccination of that individual. | No | |
Secondary | Incidence (n/person yrs) of each EOI is calculated. | Observational period of 1 year following date of vaccination of that individual. | No |
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