NCT02988739

Brief Summary

It is the aim of the present study to compare the immunogenicity induced by a laser-assisted epidermally administered seasonal influenza vaccine to an intradermally administered seasonal influenza vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 22, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

December 6, 2016

Last Update Submit

March 5, 2018

Conditions

Influenza in Human

Outcome Measures

Primary Outcomes (2)

  • Haemagglutination inhibition (HAI)

    HAI against each vaccine virus strain

    day 1 and day 29

  • Frequency of vaccine specific T-cell responders

    Number of subjects achieving a T-cell stimulation index of \>3

    day 1, day 15 and day 29

Secondary Outcomes (5)

  • Seroconversion rate

    day 1 and day 29

  • Seroprotection rate

    day 1 and day 29

  • Geometric Mean fold rise (GMFR) of antibody titers

    day 1 and day 29

  • Magnitude of T-cell response

    day 1 , day 15 and day 29

  • Frequency and severity of local and systemic adverse events following vaccination

    day 1 to day 29

Study Arms (2)

Laser assisted epidermal application

EXPERIMENTAL

Laser pretreatment: 4 adjacent areas of 2 cm² each (14mm x 14 mm) will be pretreated with an Erbium Yttrium Aluminium Garnet laser (22,7 J/cm², 2 pulses, Density: 5%) generating micropores with a depth of approximately 91 µm. 0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be topically administered on the laser-treated area.

Biological: seasonal influenza vaccineDevice: fractional Er:Yag laser

Intradermal application

ACTIVE COMPARATOR

0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be intradermally injected in the deltoid area.

Biological: seasonal influenza vaccine

Interventions

seasonal influenza vaccineBIOLOGICAL

influenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO

Also known as: INTANZA
Intradermal applicationLaser assisted epidermal application
fractional Er:Yag laserDEVICE

Fraction laser device to apply micorpores of defined depth and density into skin.

Also known as: Pantec P.L.E.A.S.E.
Laser assisted epidermal application

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent
  • years old (male or female),
  • Photo type I to IV (according to Fitzpatrick scale),
  • Subject must be willing and able to comply with study protocol for the duration of the study,
  • Females of childbearing potential (FCB) must maintain reliable contraception throughout the study.

You may not qualify if:

  • Known pregnancy or positive pregnancy test for women of child bearing potential,
  • Positive screening assessment for human immunodeficiency virus or viral hepatitis (Hepatitis B or Hepatitis C)
  • Known or suspected immune dysfunction that is caused by a medical condition, or any other cause and that would interfere with the conduct of the study,
  • Use, within the past 3 months, of any topical or systemic treatment that would interfere with assessment and/or investigational treatment (anti-inflammatory drugs, immune suppressors or any immune modulator agent),
  • Use of any topical treatment on the injection site within the last four weeks,
  • Photo type V and VI (according to Fitzpatrick scale),
  • Skin lesions or excessive hair growth at treatment site,
  • Any history of seasonal influenza in the past 6 months,
  • Any seasonal influenza vaccine in the past,
  • Preexisting HAI antibody titers of \>40 against more than one influenza strain included in the vaccine,
  • Acute illness or febrile illness (over 37,5°C) within one week prior to enrollment,
  • Hypersensitivity to elements of the influenza vaccine (e.g. egg),
  • Medical history of skin cancer,
  • History of Guillain Barre syndrome or brachial neuritis following previous vaccination,
  • Any history of having blood transfusions or administration with gamma globulin in the past 3 months
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna, University Clinic for Clinical Pharmacology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 9, 2016

Study Start

February 22, 2017

Primary Completion

July 31, 2017

Study Completion

September 30, 2017

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

AU(1)