InfluenzaPhase 2NCT00504231
Intradermal Influenza Vaccine Study in Elders
A Phase 2 study testing Fluzone Influenza Vaccine (2007-2008) in people with Influenza, run by PATH.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluzone Influenza Vaccine (2007-2008)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Jan 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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).
About this study
Official title: 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.
Read the 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.
- Conditions
- Influenza
- Being tested
- Fluzone Influenza Vaccine (2007-2008)
- Keywords
- influenza, prevention, intradermal, vaccine, delivery, elderly
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone Influenza Vaccine (2007-2008)Biological
Also called Fluzone
Manufactured by Sanofi Pasteur
| Study group | Role | What they receive |
|---|---|---|
| 0.3 mL Influenza Vaccine ID | Experimental | 60% dose - 0.3 mL delivered intradermally with needle and syringe Receives: Biological: Fluzone Influenza Vaccine (2007-2008) |
| 0.15 mL twice Influenza Vaccine ID | Experimental | 60% dose - 0.15 mL delivered twice intradermally with needle and syringe Receives: Biological: Fluzone Influenza Vaccine (2007-2008) |
| 0.5 mL Influenza Vaccine by IM | Active comparator | 100% dose - 0.5mL delivered intramuscularly with needle and syringe Receives: Biological: Fluzone Influenza Vaccine (2007-2008) |
| 0.3 mL Influenza Vaccine IM | Experimental | 60% dose - 0.3 mL delivered intramuscularly with needle and syringe Receives: Biological: Fluzone Influenza Vaccine (2007-2008) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection Pre- and Post- Vaccination
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)
Measured: 1 month
Secondary outcomes (2)
Geometric Mean Titer (GMT) Pre- and Post- Vaccination
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)
Measured: 1 month
Assessment of Reactogenicity
Maximum solicited systemic and local signs and symptoms during the week after initial vaccination, by Dose and Randomization Assignment
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- VA Puget Sound Health Care System, Seattle Institute for Biomedical and Clinical Research
- Responsible party
- Sponsor
- Investigators
- Ru-Chien Chi, MD, Principal investigator, VAPSHCSKathy Neuzil, MD, Principal investigator, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504231
- Sponsor's protocol ID
- ID/RD01
- Status last verified
- Jul 2011
- First submitted
- 12 Jul 2007
- Last updated
- 13 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 20377407
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradermal vs. Intramuscular Delivery of Influenza Vaccine in Immunocompetent Elders
- ClinicalTrials.gov ID
- NCT00504231
- Acronym / sponsor ID
- ID/RD01
- Conditions
- Influenza
- Keywords
- influenza, prevention, intradermal, vaccine, delivery, elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- VA Puget Sound Health Care System, Seattle Institute for Biomedical and Clinical Research
- Study start
- Sep 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Posted 13 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.3 mL Influenza Vaccine ID | Experimental | Biological: Fluzone Influenza Vaccine (2007-2008)60% dose - 0.3 mL delivered intradermally with needle and syringe |
| 0.15 mL twice Influenza Vaccine ID | Experimental | Biological: Fluzone Influenza Vaccine (2007-2008)60% dose - 0.15 mL delivered twice intradermally with needle and syringe |
| 0.5 mL Influenza Vaccine by IM | Active comparator | Biological: Fluzone Influenza Vaccine (2007-2008)100% dose - 0.5mL delivered intramuscularly with needle and syringe |
| 0.3 mL Influenza Vaccine IM | Experimental | Biological: Fluzone Influenza Vaccine (2007-2008)60% dose - 0.3 mL delivered intramuscularly with needle and syringe |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluzone Influenza Vaccine (2007-2008)Also: FluzoneManufactured by Sanofi Pasteur | Biological | 0.15 mL twice Influenza Vaccine ID, 0.3 mL Influenza Vaccine ID, 0.3 mL Influenza Vaccine IM, 0.5 mL Influenza Vaccine by IM |
Primary outcome
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)
2 secondary outcomes
Geometric Mean Titer (GMT) Pre- and Post- Vaccination
Time frame: 1 month
Assessment of Reactogenicity
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20377407Chi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ru-Chien Chi, MD principal investigator
VAPSHCS
Kathy Neuzil, MD principal investigator
PATH
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluzone Influenza Vaccine (2007-2008) in people with Influenza, run by PATH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprotection Pre- and Post- Vaccination (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00504231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012.