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Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU

NCT02998996 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2019-02-21

Study results available
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Summary

The main purpose of the this study is to evaluate the safety and tolerability of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigen.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

15 µg HA/strain and 1% Endocine™

intranasal administration

BIOLOGICAL

15 µg HA/strain and 2% Endocine™

intranasal administration

BIOLOGICAL

15 µg HA/strain

intranasal administration

BIOLOGICAL

intramuscular comparator

intramuscular administration

BIOLOGICAL

intranasal comparator

intranasal administration

BIOLOGICAL

Placebo, Saline

intranasal administration

Sponsors & Collaborators

  • Eurocine Vaccines AB

    lead INDUSTRY

Principal Investigators

  • Cornelia Lif-Tiberg, MD · CTC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-06-01
Completion
2017-06-01

Countries

  • Sweden

Study Locations

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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 NCT02998996 on ClinicalTrials.gov