NCT02153671

Immunogenicity of H5N1 Vaccine Following H5N2

Immunogenicity of OrniFlu® Inactivated Influenza Vaccine in Subjects Previously Immunized With Live Attenuated H5N2 Influenza Vaccine and in Non-vaccinated Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years – 51 Years
• Healthy volunteers: Accepted

Summary

This study is designed to assess whether a live attenuated Influenza vaccine (LAIV) can induce a long-lasting immune memory by comparing the immunologic response to two doses of the OrniFlu® inactivated vaccine given to subjects previously primed with LAIV and subjects who did not received LAIV.

Detailed description

This study evaluated immunogenicity of an adjuvanted A(H5N1) inactivated influenza vaccine (IIV) in healthy adult subjects who received A(H5N2) live attenuated influenza vaccine (LAIV) 1.5 years earlier (September/October 2012) and compared this with a group of naive subjects that did not participate in the previous study. Inclusion/exclusion criteria for the additional group of naive volunteers mirrored those utilized in the initial study.

Conditions

• Influenza Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	A(H5N1) inactivated influenza vaccine (IIV)	Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
BIOLOGICAL	A(H5N2) live attenuated influenza vaccine (LAIV)	Two doses of A(H5N2) live attenuated influenza vaccine (LAIV) administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-06-03
• Last updated: 2019-02-18
• Results posted: 2019-02-18

Locations

1 site across 1 country: Russia