NCT02955030

Evaluation of the Safety and Immunogenicity of a Sublingual Influenza Vaccine NSV0001 in Healthy Male Volunteers

Phase 1 Study to Determine the Safety and Immunogenicity of a Sublingual Administration of NSV0001 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Nitto Denko Corporation · Industry
• Sex: Male
• Age: 20 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of a sublingual administration of NSV0001 in healthy male volunteers.

Detailed description

NSV0001 is a quadrivalent influenza vaccine with the new adjuvant (ND002) administered by sublingual route. This study will enroll healthy male adults. Participants will receive two doses of the vaccine, 4 weeks apart, and will stay in the investigational site for 2 consecutive days after each vaccination. Participants will keep a patient diary to record the local and systemic reactions for one week after each vaccination. In addition, the safety monitoring will be extended through 6 months from the last vaccination to detect the potential immune mediated disorders (pIMD).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	NSV0001	sublingual
BIOLOGICAL	Influenza HA vaccine "Biken HA"	subcutaneous
BIOLOGICAL	Placebo	sublingual

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-03-01
• Completion: 2017-09-01
• First posted: 2016-11-04
• Last updated: 2017-09-18

Locations

1 site across 1 country: Japan