Reverse Genetic H9N2 Influenza Vaccine Study in Adults

NCT01320696 ↗

Phase 1/2 Completed 353 enrolled Alachua Government Services, Inc.

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of the study is to identify the optimal dose level of a reverse genetic (RG) reassortant H9N2 pandemic influenza vaccine for further product development.

Timeline

Start: 2011-03
Primary completion: 2011-06
Completion: 2012-05

Publications

Aichinger G, Grohmann-Izay B, van der Velden MV, Fritsch S, Koska M, Portsmouth D, Hart MK, El-Amin W, Kistner O, Barrett PN. Phase I/II randomized double-blind study of the safety and immunogenicity of a nonadjuvanted vero cell culture-derived whole-virus H9N2 influenza vaccine in healthy adults. Clin Vaccine Immunol. 2015 Jan;22(1):46-55. doi: 10.1128/CVI.00275-14. Epub 2014 Oct 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine	Vaccine	3.75 ug	Intramuscular
Subject	Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine	Vaccine	7.5 ug	Intramuscular
Subject	Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine	Vaccine	15 ug	Intramuscular
Subject	Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine	Vaccine	30 ug	Intramuscular
Subject	Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine	Vaccine	45 ug	Intramuscular

Reverse Genetic H9N2 Influenza Vaccine Study in Adults

Summary

Timeline

Publications

Drugs

Indications