NCT01982331

Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/CALIFORNIA/66/395 (H2N2) Influenza Vaccine

Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/California/66/395 (H2N2)Influenza Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart.

Detailed description

The aim of this study is to evaluate the safety profile of two intranasal doses of LAIV A/17/California/66/395 (H2N2) in healthy adults in Russia. A(H2N2) viruses which are antigenically similar to the pandemic strain A/Singapore/1/57, continue to circulate in domestic and wild bird populations, as confirmed by routine moni¬toring of avian influenza viruses. 40 adults aged 18-40 will be enrolled. They will be randomized to receive vaccine or placebo. Blood and urine will be collected during the week following each vaccination and before the next vaccination to monitor safety. Blood samples will also be collected at several timepoints to assess the volunteer's immune response to the vaccine. The total duration of the study is 16 weeks for each volunteer.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	LAIV H2N2	vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28
OTHER	Placebo	placebo delivered intranasally. .25cc to each nostril at day 0 and day 28

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-01-01
• Completion: 2014-03-01
• First posted: 2013-11-13
• Last updated: 2019-02-26
• Results posted: 2019-02-06

Locations

1 site across 1 country: Russia