Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2012 |
| End Date: | April 2016 |
Post-licensure Safety Surveillance Study of Menactra® Vaccine When Administered As a 2-dose Schedule to Children 9 Months Through 23 Months of Age.
This is a passive-surveillance study that will accrue subjects for surveillance. For each
accrued subject, surveillance for outcomes will continue for six months following the first
dose. If a second dose is given within that time, then surveillance will be continued for
six months following the second dose.
Observational Objective:
- To describe and characterize adverse events occurring after vaccination with Menactra
vaccine.
accrued subject, surveillance for outcomes will continue for six months following the first
dose. If a second dose is given within that time, then surveillance will be continued for
six months following the second dose.
Observational Objective:
- To describe and characterize adverse events occurring after vaccination with Menactra
vaccine.
The study will be carried out in collaboration with the Kaiser Permanente Medical Care
Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC).
KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter
databases that capture all medical care received by enrollees.
Vaccination will be according to routine clinical practice. Vaccination databases will be
reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.
Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC).
KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter
databases that capture all medical care received by enrollees.
Vaccination will be according to routine clinical practice. Vaccination databases will be
reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.
Inclusion Criteria:
- Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine
during the study period.
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