This study is being conducted to collect safety and immunogenicity data for the Eastern Equine Encephalitis (EEE) vaccine.
This study is being conducted to collect safety and immunogenicity data for the Eastern Equine Encephalitis (EEE) vaccine. To determine the frequency of adverse events in this Eastern Equine Encephalitis (EEE) vaccine study for all intent-to-treat subjects will be evaluated. Also the frequency of clinically confirmed and documented cases of Eastern Equine Encephalitis (EEE) disease among vaccinated subjects compliant with titer schedule after working with Eastern Equine Encephalitis (EEE) virus.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
138
Eastern Equine Encephalitis Vaccine, Inactivated, Dried
Special Immunizations Program, Division of Medicine, USAMRIID
Fort Deterick, Maryland, United States
Post-Vaccination Adverse Events by System Organ Class and Severity
The determined adverse events after vaccination (1 month) as reported by participants by severity and system organ class.
Time frame: 30 days
Post-Primary Related Adverse Events by System Organ Class and Severity
The determined adverse events after primary (11-13 months) as reported by participants by severity and system organ class.
Time frame: 11-13 months
Post-Booster Related Adverse Events by System Organ Class and Severity
The determined adverse events after primary (1-5 weeks) as reported by participants by severity and system organ class.
Time frame: 1-5 weeks
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series.
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
Time frame: 11-13 months
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month booster dose.
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
Time frame: 6 months
% vaccinated subjects with PRNT80 ≥ 1:40 at 11-13 months after first primary dose.
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
Time frame: 11-13 months
% vaccinated subjects with PRNT80 ≥ 1:40 after week 1, 2, 3, or 4 booster doses.
measure immunogenicity is the 80% plaque-reduction neutralization titer (PRNT80).
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Time frame: 1-4 weeks