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

NCT03437304 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2018-12-19

No results posted yet for this study

Summary

This is a Phase I/II, randomised, multicentre, partially double-blind (group 1, 2, 4 and 5), parallel-group study designed to primarily evaluate the safety, tolerability and immune response in older adults (age 50 to 75 years) following Immunose™ FLU vaccination at 5 sites in Sweden. A total of 300 subjects will be randomised to 1 of 7 treatment groups. The hypothesis is that Immunose™ FLU is safe and tolerable and will increase the influenza-specific mucosal immune response in older adults.

Conditions

Interventions

BIOLOGICAL

Immunose™ FLU 1%

Quadrivalent influenza vaccine with 30 μg HA/strain and 1% Endocine™, dosing volume 200 μl, intranasal administration x 2

BIOLOGICAL

Immunose™ FLU 2%, 200 μl

Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 200 μl, intranasal administration x 2

BIOLOGICAL

Immunose™ FLU 2%, 300 μl

Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 300 μl, intranasal administration x 2

BIOLOGICAL

Influenza antigen

Quadrivalent influenza vaccine with 30 μg HA/strain, dosing volume 200 μl, intranasal administration x 2

DRUG

Placebo

NaCl dosing volume 200 μl, intranasal administration x 2

BIOLOGICAL

i.m comparator

Quadrivalent influenza vaccine containing 15 μg HA/strain, 500 µl for intramuscular administration x 1

Sponsors & Collaborators

  • Eurocine Vaccines AB

    lead INDUSTRY

Principal Investigators

  • Erik Rein Hedin, MD · CTC Clinical Trial Consultants AB

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2018-06-30
Completion
2018-11-30

Countries

  • Sweden

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 NCT03437304 on ClinicalTrials.gov