Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients
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ClinicalTrials.gov Identifier: NCT01180699 |
Recruitment Status :
Completed
First Posted : August 12, 2010
Last Update Posted : May 27, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza Vaccine | Biological: Influenza vaccine: Vaxigrip or Fluviral and Intanza | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 229 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Randomized Controlled Trial Comparing Intradermal vs. Intramuscular Trivalent Inactivated Influenza Vaccine in Adult Solid Organ Transplant Recipients |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: influenza vaccine - intradermal
intradermal versus intramuscular
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Biological: Influenza 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. |
Active Comparator: influenza vaccine - intramuscular |
Biological: Influenza 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. |
- Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen [ Time Frame: 4 weeks ]
- Local and systemic adverse events to vaccination [ Time Frame: 24 hours, 48 hours and 7 days after each vaccination ]

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Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180699
Canada, Alberta | |
University of Alberta Hospital | |
Edmonton, Alberta, Canada, T6G 2E1 |
Principal Investigator: | Deepali Kumar | University of Alberta |
Responsible Party: | Deepali Kumar, Assistant Professor of Medicine, University of Alberta |
ClinicalTrials.gov Identifier: | NCT01180699 |
Other Study ID Numbers: |
KUOA-02 |
First Posted: | August 12, 2010 Key Record Dates |
Last Update Posted: | May 27, 2015 |
Last Verified: | May 2015 |
adult solid organ transplant patients |
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |