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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
Sponsor:
Collaborators:
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Information provided by (Responsible Party):
PATH

Tracking Information
First Submitted Date  ICMJE July 12, 2007
First Posted Date  ICMJE July 19, 2007
Results First Submitted Date  ICMJE January 11, 2012
Results First Posted Date  ICMJE July 13, 2012
Last Update Posted Date July 13, 2012
Study Start Date  ICMJE September 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2007)
Non-inferiority of seroconversion (HAI antibody titer >/= 1:32) between a reduced dose (0.3 ml) influenza vaccine delivered intradermally and a full dose (0.5 ml) delivered intramuscularly 1 month after vaccination. [ Time Frame: 1 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2007)
  • To compare HAI antibody titers between the group receiving a reduced dose (0.3 ml) influenza vaccine delivered intradermally and the group receiving a reduced dose (0.3 ml) delivered intramuscularly one month after vaccination. [ Time Frame: 1 month ]
  • To evaluate and compare the reactogenicity of influenza vaccine at reduced dose given intradermally as compared to reduced and full dose given intramuscularly. [ Time Frame: 1 month ]
  • To compare the reactogenicity and efficacy of giving reduced dose (0.3 ml) in 2 split volume injections (0.15 ml each), as compared to a single reduced dose (0.3 ml) given intradermally. [ Time Frame: 1 month ]
  • To compare HAI antibody titers one month after standard full dose intramuscular injection of influenza vaccine preceded one month prior by either reduced dose intradermal or intramuscular injection of influenza vaccine. [ Time Frame: 1 month ]
  • To compare cellular immune response to influenza vaccine delivered in a reduced dose intradermally or intramuscularly, or full dose delivered intramuscularly. [ Time Frame: 1 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intradermal Influenza Vaccine Study in Elders
Official Title  ICMJE Intradermal vs. Intramuscular Delivery of Influenza Vaccine in Immunocompetent Elders
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE Biological: Fluzone Influenza Vaccine (2007-2008)
Manufactured by Sanofi Pasteur
Other Name: Fluzone
Study Arms  ICMJE
  • Experimental: 0.3 mL Influenza Vaccine ID
    60% dose - 0.3 mL delivered intradermally with needle and syringe
    Intervention: Biological: Fluzone Influenza Vaccine (2007-2008)
  • Experimental: 0.15 mL twice Influenza Vaccine ID
    60% dose - 0.15 mL delivered twice intradermally with needle and syringe
    Intervention: Biological: Fluzone Influenza Vaccine (2007-2008)
  • Active Comparator: 0.5 mL Influenza Vaccine by IM
    100% dose - 0.5mL delivered intramuscularly with needle and syringe
    Intervention: Biological: Fluzone Influenza Vaccine (2007-2008)
  • Experimental: 0.3 mL Influenza Vaccine IM
    60% dose - 0.3 mL delivered intramuscularly with needle and syringe
    Intervention: Biological: Fluzone Influenza Vaccine (2007-2008)
Publications * Chi RC, Rock MT, Neuzil KM. Immunogenicity and safety of intradermal influenza vaccination in healthy older adults. Clin Infect Dis. 2010 May 15;50(10):1331-8. doi: 10.1086/652144.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2012)
257
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2007)
300
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00504231
Other Study ID Numbers  ICMJE ID/RD01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PATH
Study Sponsor  ICMJE PATH
Collaborators  ICMJE
  • VA Puget Sound Health Care System
  • Seattle Institute for Biomedical and Clinical Research
Investigators  ICMJE
Principal Investigator: Ru-Chien Chi, MD VAPSHCS
Principal Investigator: Kathy Neuzil, MD PATH
PRS Account PATH
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP