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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Biological: Fluzone Influenza Vaccine (2007-2008) | Phase 2 |
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 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

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 |
- 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)
- 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

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
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).

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
Principal Investigator: | Ru-Chien Chi, MD | VAPSHCS | |
Principal Investigator: | Kathy Neuzil, MD | PATH |
Responsible Party: | PATH |
ClinicalTrials.gov Identifier: | NCT00504231 |
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 |
influenza prevention intradermal |
vaccine delivery elderly |
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |