Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00402805
• Date of registration: 21/11/2006
• Primary sponsor: University Health Network, Toronto
• Public title: Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
• Scientific title: Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
• Date of first enrolment: October 2006
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00402805
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Canada

Contacts

• Name: Deepali Kumar, MD
• Affiliation: University Health Network, Toronto

Key inclusion & exclusion criteria

Inclusion Criteria:

- Lung transplant recipients greater than 3 months post-transplant

Exclusion Criteria:

- · Egg allergy

- Previous life-threatening reaction to influenza vaccine (ie 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



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza Vaccines

Lung Transplantation

Intervention(s)

Biological: Trivalent Inactivated Influenza Vaccine

Primary Outcome(s)

HIA titers 4 weeks after influenza vaccination

Secondary Outcome(s)

Local and systemic adverse events to vaccination and rates

of allograft rejection in the 6 months following vaccination

Secondary ID(s)

06-0380-AE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors