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

NCT02955030 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-09-18

No results posted yet for this study

Summary

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

Conditions

Interventions

BIOLOGICAL

NSV0001

sublingual

BIOLOGICAL

Influenza HA vaccine "Biken HA"

subcutaneous

BIOLOGICAL

Placebo

sublingual

Sponsors & Collaborators

  • Nitto Denko Corporation

    lead INDUSTRY

Principal Investigators

  • Senior fellow · Nitto Denko Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-03-31
Completion
2017-09-30

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02955030 on ClinicalTrials.gov