NCT00760175

Brief Summary

The influenza virus, commonly called the flu, is a common source of infection in lung transplant patients and can often lead to pneumonia and possibly rejection. The annual influenza vaccine is the most important strategy used to prevent infection but it is not effective in all lung transplant patients. It has been thought that the response to the vaccine may be improved if it is given into the skin (intradermal) rather than the muscle (intramuscular). We hypothesize that a significantly greater proportion of patients will respond to vaccination using the intradermal influenza vaccine compared to the intramuscular vaccine.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

September 25, 2008

Last Update Submit

May 26, 2015

Conditions

Influenza VirusInfluenza Vaccine

Keywords

Lung transplant RecipientsVaxigrip

Outcome Measures

Primary Outcomes (1)

  • Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers Seroprotection rate: HIA titers of >/= 1:40

    4 weeks

Secondary Outcomes (1)

  • Local and systemic adverse events to vaccination

    24 hours, 48 hours and 7 days after each vaccination

Study Arms (2)

intradermal

ACTIVE COMPARATOR
Biological: Vaxigrip (Aventis-Pasteur Canada)

intramuscular

ACTIVE COMPARATOR
Biological: Vaxigrip (Aventis-Pasteur Canada)

Interventions

Vaxigrip (Aventis-Pasteur Canada)BIOLOGICAL

The intramuscular dose (0.5 mL contains 15 micrograms antigen from each strain and the intradermal doses (2 x 0.1 mL)contain 6 micrograms antigen from each strain.

Also known as: Influenza vaccine
intradermalintramuscular

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • Greater than 3 months post-transplant
  • Outpatient status

You may not qualify if:

  • Has already received influenza vaccination for 2008-2009 season
  • Egg allergy
  • Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome)
  • On anticoagulants such as warfarin that precludes intramuscular injection
  • Ongoing therapy for rejection
  • Febrile illness in the past two weeks
  • Unable to provide informed consent
  • Unable to comply with study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, T6G 2E1, Canada

Location

University Hospital of Lausanne

Lausanne, Switzerland

Location

Related Publications (1)

  • Manuel O, Humar A, Chen MH, Chernenko S, Singer LG, Cobos I, Kumar D. Immunogenicity and safety of an intradermal boosting strategy for vaccination against influenza in lung transplant recipients. Am J Transplant. 2007 Nov;7(11):2567-72. doi: 10.1111/j.1600-6143.2007.01982.x. Epub 2007 Oct 1.

    PMID: 17908277RESULT

Related Links

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigripInfluenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Deepali Kumar, Msc, FRCPC

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

CA(1)CH(1)