Influenza Clinical Trial
Official title:
A Multicenter, Non-Blinded, Dose Escalation Study to Evaluate the Immunogenicity, Safety and Optimal Dose of Three Doses Regimen of Recombinant Influenza H5N1 Vaccine, After Two Vaccinations Given 3 Weeks Apart, in Healthy Young Adults.
UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004).
The purpose of the present study is to evaluate immunogenicity, safety and optimal dose
among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per
patient with a 3 week interval between vaccination in healthy young adults.
Immunogenicity will be confirmed by both microneutralization (MN) antibody and
hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving
different doses of UMN-0501. There will be three dose groups with 30 subjects per group for
a total of 90 healthy young adults aged 20-40 years enrolled in this study.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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