Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Adults and Elders

Summary

This was a randomized, laboratory-blinded study in healthy male and non-pregnant female designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 vaccine (AdimFlu-S). In the adult cohort, all volunteers were randomized in a 1:1:1 ratio to receive 2 injections of AdimFlu-S (A/H1N1) 15 mcg HA at 3 weeks apart, 2 injections of AdimFlu-S (A/H1N1) 30 mcg HA at 3 weeks apart or 1 injection of AdimFlu-S (A/H1N1) 15 mcg HA. In the elders cohort, all volunteers were randomized in a 1:1 ratio to receive 2 injections of AdimFlu-S (A/H1N1) 15 mcg HA at 3 weeks apart or 2 injections of AdimFlu-S (A/H1N1) 30 mcg HA at 3 weeks apart. Following immunization, safety was measured by assessment of adverse events for 6 weeks following the first vaccination, serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination; and reactogenicity to the vaccines for 7 days following each vaccination. Immunogenicity testing included hemagglutinin inhibition (HAI) testing on serum obtained before first vaccination, and three and six weeks after first vaccination.

Timeline

Start

2009-09

Primary completion

2010-04

Completion

2010-04

Publications

• Kung HC, Huang KC, Kao TM, Lee YC, Chang FY, Wang NC, Liu YC, Lee WS, Liu HJ, Chen CI, Chen CH, Huang LM, Hsieh SM. A clinical study to assess the immunogenicity and safety of a monovalent 2009 influenza A (H1N1) vaccine in an area with low-level epidemics of pandemic influenza. Vaccine. 2010 Oct 21;28(45):7337-43. doi: 10.1016/j.vaccine.2010.08.073. Epub 2010 Sep 17.
• Kao TM, Hsieh SM, Kung HC, Lee YC, Huang KC, Huang LM, Chang FY, Wang NC, Liu YC, Lee WS, Liu HE, Chen CI, Chen CH. Immune response of single dose vaccination against 2009 pandemic influenza A (H1N1) in the Taiwanese elderly. Vaccine. 2010 Aug 31;28(38):6159-63. doi: 10.1016/j.vaccine.2010.07.026. Epub 2010 Jul 24.

Drugs

Indications