Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients

A Randomized Controlled Trial Comparing Intradermal vs. Intramuscular Trivalent Inactivated Influenza Vaccine in Adult Solid Organ Transplant Recipients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01180699

Enrollment

229

Registered

2010-08-12

Start date

2010-10-31

Completion date

2012-12-31

Last updated

2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Vaccine

Keywords

adult solid organ transplant patients

Brief summary

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia and contribute to the development of rejection. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that a single intramuscular dose has poor immunogenicity. There are no studies that define the effect of intradermal doses in this population. We plan to study the immunogenicity of two different administration routes of the influenza vaccine in 200 solid organ transplant patients during the 2010-2011 season. Patients will be randomized to receive influenza vaccine either intradermally or intramuscularly. We hypothesize that the patients who receive the intradermal influenza vaccine will significantly reach a higher response to the vaccine. This study advances research on the prevention of serious viral infections in transplant recipients. Results from this study have the potential to directly improve patient care. If the use of the intradermal influenza vaccine is successful, this strategy may lead to a significant reduction in burden of disease, hospitalizations, and long-term morbidity.

Interventions

BIOLOGICALInfluenza vaccine: Vaxigrip or Fluviral and Intanza

Patients will be randomized to receive either one intradermal dose of 0.1 mL or one intramuscular injection of 0.5 mL of the standard influenza vaccine in the deltoid muscle of the nondominant arm.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

Healthy volunteers

Inclusion criteria

* Age ≥ 18 and ≤ 59, * Greater than 3 months post-transplant, * Any solid organ transplant (kidney, liver, heart, lung, pancreas, intestinal or combinations of the aforementioned organs)

Exclusion criteria

* Has already received influenza vaccination for 2010-2011 season; * Egg allergy, * Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome), * Ongoing therapy for rejection, * Febrile illness in the past two weeks, * Unable to provide informed consent, * Unable to comply with study protocol

Design outcomes

Primary

Measure	Time frame
Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen	4 weeks

Secondary

Measure	Time frame
Local and systemic adverse events to vaccination	24 hours, 48 hours and 7 days after each vaccination

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026