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Intradermal Influenza Vaccine Study in Elders

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ClinicalTrials.gov Identifier: NCT00504231
Recruitment Status : Completed
First Posted : July 19, 2007
Results First Posted : July 13, 2012
Last Update Posted : July 13, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
This randomized trial compared the immunogenicity of 60% dose intradermal (ID) influenza vaccination to standard intramuscular (IM) vaccination of full-dose or 60% dose vaccine. Pre- and postvaccination measurements in the hemagglutination inhibition antibody (HAI) titer were compared. Participants who received reduced-dose vaccine were revaccinated with full-dose IM vaccine.

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluzone Influenza Vaccine (2007-2008) Phase 2

Detailed Description:
This study was an open-label randomized trial consisting of community-dwelling adults 65 years and older living in Puget Sound area in Washington State. Subjects were enrolled and randomly assigned to receive licensed, 2007-2008 Northern Hemisphere TIV vaccine (Fluzone, lot U2440AA; Sanofi Pasteur) containing concentrations of hemagglutinin of each of A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), and B/Malaysia/2506/2004 (B): 15 ug/0.5 mL by the IM route, 9 ug/0.3 mL by the ID or IM route, or 4.5 ug/0.15 mL given twice by ID route to the nondominant arm. A block randomization scheme (1:1:1:1), stratified by sex, was used. For IM vaccination, 0.3 mL or 0.5 mL of vaccine was removed from a multidose (5 mL) vial through a 25-gauge, 1-inch detachable needle (Becton Dickinson) and was injected into the deltoid muscle at a 90 degree angle to the skin. For ID vaccination, 0.3 mL or 0.15 mL was drawn by a TB syringe through a 25-gauge, 5/8-inch needle (Terumo Medical). The needle was inserted at a 15 degree angle to the skin overlying the deltoid of the arm. The vaccine was slowly injected until all material was expelled and induration appeared. Subjects randomized to the 0.15-mL group received 2 side-by-side ID injections 3 cm apart. Participants returned at 4 weeks to determine postvaccination antibody titers. At this follow-up visit, those assigned to reduced dose IM or ID influenza vaccinations then received full-dose IM influenza vaccination. These participants returned in another 4 weeks to repeat HAI titers. A nonrandomized subset of subjects (based on availability and willingness to participate) returned at 14 days after initial vaccination for T cell assays in an exploratory substudy to examine cellular immune response.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intradermal vs. Intramuscular Delivery of Influenza Vaccine in Immunocompetent Elders
Study Start Date : September 2007
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 0.3 mL Influenza Vaccine ID
60% dose - 0.3 mL delivered intradermally with needle and syringe
Biological: Fluzone Influenza Vaccine (2007-2008)
Manufactured by Sanofi Pasteur
Other Name: Fluzone
Experimental: 0.15 mL twice Influenza Vaccine ID
60% dose - 0.15 mL delivered twice intradermally with needle and syringe
Biological: Fluzone Influenza Vaccine (2007-2008)
Manufactured by Sanofi Pasteur
Other Name: Fluzone
Active Comparator: 0.5 mL Influenza Vaccine by IM
100% dose - 0.5mL delivered intramuscularly with needle and syringe
Biological: Fluzone Influenza Vaccine (2007-2008)
Manufactured by Sanofi Pasteur
Other Name: Fluzone
Experimental: 0.3 mL Influenza Vaccine IM
60% dose - 0.3 mL delivered intramuscularly with needle and syringe
Biological: Fluzone Influenza Vaccine (2007-2008)
Manufactured by Sanofi Pasteur
Other Name: Fluzone

Outcome Measures

Primary Outcome Measures :
  1. Seroprotection Pre- and Post- Vaccination [ Time Frame: 1 month ]
    Seroprotection before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) Intramuscular (IM) or Reduced-Dose (9 mg) Intradermal (ID) Injections for A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)

Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) Pre- and Post- Vaccination [ Time Frame: 1 month ]
    GMT before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) IM or Reduced-Dose (9 mg) ID Injections. A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)

  2. Assessment of Reactogenicity [ Time Frame: 1 week ]
    Maximum solicited systemic and local signs and symptoms during the week after initial vaccination, by Dose and Randomization Assignment

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Ambulatory, medically stable persons 65 years of age or older
  • Able to read and understand informed consent
  • Available during the trial period and for follow-up
  • Able to understand and comply with planned study procedures
  • Able to be contacted by telephone for follow-up of adverse events

Exclusion Criteria:

  • Known allergy to eggs or other components of vaccine (i.e., thimerosal)
  • History of Guillain-Barré Syndrome (GBS)
  • Has a confirmed or suspected immunodeficient or immunosuppressive condition (including congenital or acquired immunosuppressive therapy, and human immunodeficiency virus [HIV])
  • End-stage renal disease requiring hemodialysis
  • Active neoplastic disease or history of any hematologic malignancy (except localized skin or prostate cancer that is stable in the absence of therapy)
  • Acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses (including but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin controlled diabetes mellitus)
  • Use of experimental vaccines within the month prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products during the duration of the study.
  • Receipt of immunoglobulin or other blood product within 3 months prior to enrollment
  • Receipt of other licensed vaccines within the preceding 4 weeks
  • History of a severe reaction following influenza vaccination
  • Current or planned participation in a research study of an investigational drug. Participation in research studies that involve use of licensed drugs, for either approved or investigational indications, will be permitted with the approval of the PI, as will participation in research studies that do not involve vaccines or medications.
  • Current use or previous chronic administration, defined as >14 days during the previous six months, of immunosuppressants or other immune-modifying drugs. (For oral or injected corticosteroids, the immune-modifying dose is defined as prednisone or its equivalent >10 mg/day or >800mcg per day of inhaled beclomethasone dipropionate or equivalent ). Topical steroids are allowed.
  • Use of cytotoxic therapy in the previous 2 years.
  • Plans to receive cytotoxic therapy during the study period.
  • Concurrent moderate to severe illness. Need to defer vaccination until recovery. (Vaccination is not contraindicated in subjects with mild illnesses or with low-grade fever).
Contacts and Locations

Information from the National Library of Medicine

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): NCT00504231

Sponsors and Collaborators
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Principal Investigator: Ru-Chien Chi, MD VAPSHCS
Principal Investigator: Kathy Neuzil, MD PATH
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT00504231     History of Changes
Other Study ID Numbers: ID/RD01
First Posted: July 19, 2007    Key Record Dates
Results First Posted: July 13, 2012
Last Update Posted: July 13, 2012
Last Verified: July 2011

Keywords provided by PATH:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs