- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00504231
Intradermal Influenza Vaccine Study in Elders
June 8, 2012 updated by: PATH
Intradermal vs. Intramuscular Delivery of Influenza Vaccine in Immunocompetent Elders
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
257
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.3 mL Influenza Vaccine ID
60% dose - 0.3 mL delivered intradermally with needle and syringe
|
Manufactured by Sanofi Pasteur
Other Names:
|
Experimental: 0.15 mL twice Influenza Vaccine ID
60% dose - 0.15 mL delivered twice intradermally with needle and syringe
|
Manufactured by Sanofi Pasteur
Other Names:
|
Active Comparator: 0.5 mL Influenza Vaccine by IM
100% dose - 0.5mL delivered intramuscularly with needle and syringe
|
Manufactured by Sanofi Pasteur
Other Names:
|
Experimental: 0.3 mL Influenza Vaccine IM
60% dose - 0.3 mL delivered intramuscularly with needle and syringe
|
Manufactured by Sanofi Pasteur
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 month
|
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
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ru-Chien Chi, MD, VAPSHCS
- Principal Investigator: Kathy Neuzil, MD, PATH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
July 12, 2007
First Submitted That Met QC Criteria
July 18, 2007
First Posted (Estimate)
July 19, 2007
Study Record Updates
Last Update Posted (Estimate)
July 13, 2012
Last Update Submitted That Met QC Criteria
June 8, 2012
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID/RD01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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