NCT00558649

Brief Summary

The purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 15, 2007

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 10, 2013

Status Verified

November 1, 2007

Enrollment Period

4 months

First QC Date

May 27, 2007

Last Update Submit

May 8, 2013

Conditions

Influenza, Human

Study Arms (3)

1

EXPERIMENTAL

Low dose flu vaccine delivered intradermally using microneedles

Biological: Flu Vaccine (FLUARIX®)

2

EXPERIMENTAL

Medium dose flu vaccine delivered intradermally using microneedles

Biological: Flu Vaccine (FLUARIX®)

3

ACTIVE COMPARATOR

Standard dose flu vaccine delivered intramuscularly with a regular needle

Biological: Flu Vaccine (FLUARIX®)

Interventions

Flu Vaccine (FLUARIX®)BIOLOGICAL

Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula

123

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed an Informed Consent
  • No previous immune-related disease

You may not qualify if:

  • Significant illness within the previous 4 weeks
  • Subjects who have received an influenza vaccine within the previous 6 months
  • An active viral diseases
  • Pregnant or nursing women
  • Any known contraindication to the study vaccine or vaccine ingredients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccinesfluarix

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Pierre Van Damme, MD, PhD

    Center for the Evaluation of Vaccination, University of Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2007

First Posted

November 15, 2007

Study Start

May 1, 2007

Primary Completion

September 1, 2007

Study Completion

December 1, 2007

Last Updated

May 10, 2013

Record last verified: 2007-11