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.
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.
Study Type
OBSERVATIONAL
Enrollment
116
0.5 mL, Intramuscular
Unnamed facility
Oakland, California, United States
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.
Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.
Time frame: Day 0 up to Day 75 post-vaccination
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