Status:
COMPLETED
Safety of MenACWY-CRM Vaccination in Adolescents
Lead Sponsor:
Novartis Vaccines
Collaborating Sponsors:
Novartis
Conditions:
Meningococcal Disease
Eligibility:
All Genders
11-21 years
Brief Summary
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 receiv...
Detailed 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: Seizur...
Eligibility Criteria
Inclusion
- Enrolled in the HMO for at least 6 months prior to vaccination
- Between the ages of 11 and 21 years (inclusive - i.e. has not reached their 22nd birthday) at the time of the vaccination.
- Received the vaccine during the study period
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
55397 Patients enrolled
Trial Details
Trial ID
NCT01452464
Start Date
September 1 2011
End Date
February 1 2015
Last Update
February 26 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Riverside Medical Center Campus, 10800 Magnolia Ave
Riverside, California, United States, 92505
2
San Diego Medical Center Campus, 4647 Zion Ave 92120
San Diego, California, United States, 92120
3
Fontana Medical Center Campus
Valley Annex, 16994 E. Valley Blvd., Fontana, California, United States, 92335