Finding studies
Finding studies
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Lead
Albert B. Sabin Vaccine Institute
With
Primary Endpoints: Safety Assessment of product safety will include clinical observation and monitoring of clinical chemistry and hematology parameters. Safety will be closely monitored after injection and evaluated through Day 99 and one additional safety follow-up telephone call on Day 181 (± 14 Days). The following parameters will be assessed: * Occurrence and severity of solicited local reactogenicity signs and symptoms for 7 days following the vaccination * Occurrence and severity of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination * Change from baseline for safety laboratory measures * Occurrence of adverse events of all severities through 28 days after vaccination * Occurrence of serious adverse events and new chronic medical conditions through the last safety follow up call at Day 181(± 14 days) Secondary Endpoints : * Antibody levels against vaccines cAd3-EBO-S and cAd3 Marburg as measured by enzyme-linked immunosorbent assay (ELISA) on Day 1, 15, 22, 29, 36, 43, 50, 57 and 64 * 20 Liters of plasma per vaccine group will be collected for the purpose of assay development
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
