InfluenzaPhase 2NCT00170547
Comparison of Delivery Routes of Flu Vaccine in Adults
A Phase 2 study testing Trivalent inactivated influenza vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
Trial summary
This protocol is to compare the immune response of different influenza vaccines given by two different routes of administration in healthy adults ages 18 to 64 years. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Trivalent inactivated influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,597 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2005to Feb 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is healthy, as determined by medical history
- Over 18 years of age and not yet 65 years old
- Provides written informed consent
- Able to attend all scheduled visits and to comply with all trial procedures
- Women may be menopausal of 1 year or more or sugically sterile. Women of child-bearing potential must agree to be abstinent or to use a licensed form of barrier or hormonal contraception for the entire study period, and have a negative pregnancy test within 24 hours prior to vaccination.
Who cannot join
- Breast-feeding
- Receipt of an investigational drug, biologic or device in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- History of Guillain-Barré Syndrome
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy
- Hypersensitivity to any of the vaccine components (including eggs or egg products or thimerosol and gelatin) or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
Show all 20Show fewer
- Chronic illness that could interfere with trial conduct or completion
- Blood or blood-derived products received in the past 3 months
- Has received any inactivated vaccine within 2 weeks or live vaccine within 4 weeks prior to enrollment into this study
- Vaccination planned within the 4 weeks following the trial vaccination
- Known current HIV, hepatitis B (HBsAg) or hepatitis C infection or seropositivity
- Prior vaccination against influenza within the past 6 months
- Allergy shot in the 7-day period prior to enrollment and must not be scheduled to receive any allergy shots in the 7-day period after enrollment
- On coumadin or heparin therapy or has known thrombocytopenia or bleeding disorder contraindicating vaccination
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Febrile illness temperature >= 37.5°C on Day 0, prior to enrollment and vaccination
- Any condition, that, in the opinion of the investigator, would pose a health risk to the participant
- History of alcohol or drug abuse in the last 5 years
- Planned travel outside the US between vaccination and the second study visit
- Presence of any active skin disease at the injection site that, in the opinion of the Investigator, would impact vaccine delivery or assessment of vaccination site
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Duke Health Center
Durham, North Carolina, 27704
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa - Vaccine Research & Education Unit
Iowa City, Iowa, 52242-2600
Vanderbilt University
Nashville, Tennessee, 37232
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, 14642-0001
Saint Louis University
St Louis, Missouri, 63110
Stanford University School of Medicine
Stanford, California, 94305-2200
UCLA Center For Vaccine Research
Torrance, California, 90509
About this study
Official title: Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route Compared to an Intramuscular Vaccination With Fluzone(R) in Healthy Adults
This protocol is to compare the immune response of different influenza vaccines given by two different routes of administration in healthy adults ages 18 to 64 years.
Read the detailed description
This is a multi-center, randomized, partially blinded trial to compare the safety and immunogenicity of intramuscularly versus intradermally administered influenza vaccine in healthy 18-64 year old adults. Subjects will have blood drawn immediately prior to and approximately three to four weeks after vaccination. After the completion of the trial, all subjects will be offered influenza vaccine of the 2005-2006 formulation.
- Conditions
- Influenza
- Being tested
- Trivalent inactivated influenza vaccine
- Keywords
- inactivated, trivalent, influenza, vaccine, Fluzone
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent inactivated influenza vaccineBiological
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain.. Group 4: 382 subjects receive Fluzone 15 mcg IM on day 0
Trivalent inactivated influenza vaccineBiological
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Group 1: 382 subjects receive 6 mcg ID with BD system. Group 2: 382 subjects receive 9 mcg ID with BD system, all doses on day 0.
Trivalent inactivated influenza vaccineBiological
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain..Group 3: 382 subjects receive 3 mcg Fluzone ID using Mantoux technique on day 0.
| Study group | Role | What they receive |
|---|---|---|
| Group 3 | Experimental | 382 subjects will receive one 3 mcg dose of Fluzone intradermally using the Mantoux technique on Day 0, Receives: Biological: Trivalent inactivated influenza vaccine |
| Group 4 | Experimental | 382 subjects will receive one 15 mcg dose Fluzone vaccine intramuscularly (IM) on Day 0, Receives: Biological: Trivalent inactivated influenza vaccine |
| Group 1 | Experimental | 382 subjects will receive one 6 mcg dose of Trivalent inactivated influenza vaccine (TIV) intradermally (ID) with the BD ID System on Day 0, Receives: Biological: Trivalent inactivated influenza vaccine |
| Group 2 | Experimental | 382 subjects will receive one 9 mcg dose of TIV intradermally (ID) with the BD ID System on Day 0, Receives: Biological: Trivalent inactivated influenza vaccine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 1,597 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170547
- Sponsor's protocol ID
- 05-0075
- Status last verified
- Jul 2006
- First submitted
- 9 Sep 2005
- Last updated
- 5 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route Compared to an Intramuscular Vaccination With Fluzone(R) in Healthy Adults
- ClinicalTrials.gov ID
- NCT00170547
- Acronym / sponsor ID
- 05-0075
- Conditions
- Influenza
- Keywords
- inactivated, trivalent, influenza, vaccine, Fluzone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,597 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Feb 2006
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is to compare the immune response of different influenza vaccines given by two different routes of administration in healthy adults ages 18 to 64 years.
Detailed description
This is a multi-center, randomized, partially blinded trial to compare the safety and immunogenicity of intramuscularly versus intradermally administered influenza vaccine in healthy 18-64 year old adults. Subjects will have blood drawn immediately prior to and approximately three to four weeks after vaccination. After the completion of the trial, all subjects will be offered influenza vaccine of the 2005-2006 formulation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 3 | Experimental | Biological: Trivalent inactivated influenza vaccine382 subjects will receive one 3 mcg dose of Fluzone intradermally using the Mantoux technique on Day 0, |
| Group 4 | Experimental | Biological: Trivalent inactivated influenza vaccine382 subjects will receive one 15 mcg dose Fluzone vaccine intramuscularly (IM) on Day 0, |
| Group 1 | Experimental | Biological: Trivalent inactivated influenza vaccine382 subjects will receive one 6 mcg dose of Trivalent inactivated influenza vaccine (TIV) intradermally (ID) with the BD ID System on Day 0, |
| Group 2 | Experimental | Biological: Trivalent inactivated influenza vaccine382 subjects will receive one 9 mcg dose of TIV intradermally (ID) with the BD ID System on Day 0, |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is healthy, as determined by medical history
- Over 18 years of age and not yet 65 years old
- Provides written informed consent
- Able to attend all scheduled visits and to comply with all trial procedures
- Women may be menopausal of 1 year or more or sugically sterile. Women of child-bearing potential must agree to be abstinent or to use a licensed form of barrier or hormonal contraception for the entire study period, and have a negative pregnancy test within 24 hours prior to vaccination.
Key exclusion criteria (20 listed)
- Breast-feeding
- Receipt of an investigational drug, biologic or device in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- History of Guillain-Barré Syndrome
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid 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 |
|---|---|---|
| Trivalent inactivated influenza vaccineA synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain.. Group 4: 382 subjects receive Fluzone 15 mcg IM on day 0 | Biological | Group 4 |
| Trivalent inactivated influenza vaccineA synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Group 1: 382 subjects receive 6 mcg ID with BD system. Group 2: 382 subjects receive 9 mcg ID with BD system, all doses on day 0. | Biological | Group 1, Group 2 |
| Trivalent inactivated influenza vaccineA synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain..Group 3: 382 subjects receive 3 mcg Fluzone ID using Mantoux technique on day 0. | Biological | Group 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trivalent inactivated influenza vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
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 20 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 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 5 Dec 2014.