This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
156
Escalating dose levels
Saline
Miami Research Associates
Miami, Florida, United States
Frequency of solicited AEs (local and systemic reactogenicity events)
Time frame: 7 days following each dose administration
Frequency of unsolicited adverse events
Time frame: 21 days following each dose administration
Frequency of serious adverse events (SAE), adverse events of special interest (AESI), medically-attended AEs, and new onset of chronic illness
Time frame: One year after last dose administration
Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample
Time frame: One year after last dose administration
Seroconversion rates in comparison to baseline samples
Time frame: One year after last dose administration
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