drugset

drugset / Trial / NCT01177202

Study of the Safety and Immunogenicity of H1N1 Vaccine

NCT01177202 ↗

Phase 1 Completed 80 enrolled Fraunhofer, Center for Molecular Biotechnology Defense Advanced Research Projects Agency · collab Walter Reed Army Institute of Research (WRAIR) · collab

RandomizedFactorialSingle-blindPrevention

Summary

The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A H1N1 Vaccine In Healthy Adults

Timeline

Start: 2010-09
Primary completion: 2011-05
Completion: 2012-10

Publications

Cummings JF, Guerrero ML, Moon JE, Waterman P, Nielsen RK, Jefferson S, Gross FL, Hancock K, Katz JM, Yusibov V; Fraunhofer USA Center for Molecular Biotechnology Study Group. Safety and immunogenicity of a plant-produced recombinant monomer hemagglutinin-based influenza vaccine derived from influenza A (H1N1)pdm09 virus: a Phase 1 dose-escalation study in healthy adults. Vaccine. 2014 Apr 17;32(19):2251-9. doi: 10.1016/j.vaccine.2013.10.017. Epub 2013 Oct 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HAC1	Vaccine	15 ug	Intramuscular
Subject	HAC1	Vaccine	45 ug	Intramuscular
Subject	HAC1	Vaccine	90 ug	Intramuscular

Indications