Safety Trial of Monovalent Whole Virus Influenza (H1N1) Vaccine

Summary

The study hypothesis is that two 0.5 ml doses of non-adjuvanted whole virion monovalent A/H1N1 influenza vaccine (IVACFLU)--each dose with an HA content of 15 mcg from A/California/07/2009 (H1N1)-like virus--will be safe and immunogenic in healthy adults.

Timeline

Start

2012-04

Primary completion

2012-11

Completion

2012-12

Publications

• Thang HV, Huong VM, Victor JC, Van CB, Nga NT, Be LV, Cuong NP, Tsvetnitsky V, Neuzil KM, Power M, Flores J. Safety and immunogenicity of inactivated monovalent influenza A/H1N1 vaccine candidate manufactured in Vietnam. Vaccine. 2018 Nov 12;36(46):6918-6925. doi: 10.1016/j.vaccine.2018.10.013. Epub 2018 Oct 15.

Drugs

Indications