Orthomyxoviridae InfectionPhase 2NCT00388583
Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects
A Phase 2 study testing Split, Inactivated, Trivalent Influenza Vaccine in people with Orthomyxoviridae Infection and Influenza, run by Sanofi at 17 sites in United States.
Trial summary
As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly. Primary Objective: To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthomyxoviridae Infection, Influenza, Myxovirus Infection
- What is being tested?
- Split, Inactivated, Trivalent Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 817 participants
- Where
- 17 sitesUnited States
- Study dates
- Sep 2006to Sep 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
- Aged ≥ 65 years on the day of vaccination.
- Informed consent form signed.
- Medically stable (Subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, congestive cardiac disorders or hypothyroidism, as long as their symptoms/signs are controlled).
- Able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Fluzone® vaccine or a vaccine containing the same substances (the list of vaccine components is included in the Investigator's Brochure).
- Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
- Systemic corticosteroid therapy as follows:
- Continuous use with a dosage equivalent to > 15 mg/day of oral prednisone for 90 days preceding vaccination
- Sporadic use with a dose of > 40 mg/day of oral prednisone for > 14 days in the 90 days preceding vaccination.
- Note: Use of topical or inhalant corticosteroids is acceptable.
Show all 22Show fewer
- Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease-free for ≥ 5 years).
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Receipt of blood or blood-derived products in the past 3 months.
- Vaccination against influenza in the past 6 months.
- Any vaccination in the 4 weeks preceding the trial vaccination.
- Vaccination planned in the 4 weeks following the trial vaccination.
- Participation in another clinical trial in the 4 weeks preceding trial vaccination.
- Planned participation in another clinical trial during the present trial period. Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Known current HIV, hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
- Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Acute illness and febrile illness with a temperature ≥ 38.0°C [or 100.4°F]) 72 hours before or on the day of inclusion.
- Received antibiotics therapy within 72 hours preceding the trial vaccination.
- Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination.
- Any condition, which in the opinion of the investigator would pose a health risk to the participant.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Alabaster, Alabama
Study site
Bensalem, Pennsylvania
Study site
Brooklyn, New York
Study site
Chicago, Illinois
Study site
Fort Worth, Texas
Study site
Fountain Valley, California
Study site
Galveston, Texas
Study site
Grove City, Pennsylvania
Study site
Johnstown, Pennsylvania
Study site
Layton, Utah
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Pinellas Park, Florida
Study site
Pittsburgh, Pennsylvania
Study site
South Jordan, Utah
Study site
Springfield, Missouri
Study site
Tucson, Arizona
About this study
Official title: Immunogenicity and Safety of The Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Ambulatory Elderly Subjects
As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly.
Primary Objective:
To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®.
Secondary Objectives:
Immunogenicity:
To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®.
Safety:
To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
- Conditions
- Orthomyxoviridae Infection, Influenza, Myxovirus Infection
- Being tested
- Split, Inactivated, Trivalent Influenza Vaccine
- Keywords
- Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Elderly.
- Medical subject headings
- Orthomyxoviridae Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split, Inactivated, Trivalent Influenza VaccineBiological
Also called Fluzone
0.1 mL, Intradermal
Split, Inactivated, Trivalent Influenza VaccineBiological
Also called Fluzone® 2006/2007 Formulation
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Fluzone Intradermal (ID) Vaccine Group | Experimental | Participants received a dose of Fluzone Intradermal (ID) Influenza Vaccine Receives: Biological: Split, Inactivated, Trivalent Influenza Vaccine |
| Fluzone Intramuscular (IM) Vaccine Group | Active comparator | Participants received a dose of Fluzone Intramuscular (IM) Influenza Vaccine. Receives: Biological: Split, Inactivated, Trivalent Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Measured: Pre-vaccination and Day 28 post-vaccination
Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40
Measured: Day 28 post-vaccination
Secondary outcomes (2)
Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Measured: Pre- and Day 28 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus.
Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Measured: Day 0 up to 7 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2007
- Study completionSep 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.
- Other trials for Orthomyxoviridae InfectionStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- None (open label)
- Enrolment
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388583
- Sponsor's protocol ID
- FID04
- Status last verified
- Apr 2012
- First submitted
- 16 Oct 2006
- Last updated
- 18 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of The Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Ambulatory Elderly Subjects
- ClinicalTrials.gov ID
- NCT00388583
- Acronym / sponsor ID
- FID04
- Conditions
- Orthomyxoviridae Infection, Influenza, Myxovirus Infection
- Keywords
- Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Elderly.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 17 Oct 2006 (estimated)
- Results
- Posted 13 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly.
Primary Objective:
To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®.
Secondary Objectives:
Immunogenicity:
To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®.
Safety:
To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluzone Intradermal (ID) Vaccine Group | Experimental | Biological: Split, Inactivated, Trivalent Influenza VaccineParticipants received a dose of Fluzone Intradermal (ID) Influenza Vaccine |
| Fluzone Intramuscular (IM) Vaccine Group | Active comparator | Biological: Split, Inactivated, Trivalent Influenza VaccineParticipants received a dose of Fluzone Intramuscular (IM) Influenza Vaccine. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged ≥ 65 years on the day of vaccination.
- Informed consent form signed.
- Medically stable (Subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, congestive cardiac disorders or hypothyroidism, as long as their symptoms/signs are controlled).
- Able to attend all scheduled visits and to comply with all trial procedures.
Key exclusion criteria (22 listed)
- Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Fluzone® vaccine or a vaccine containing the same substances (the list of vaccine components is included in the Investigator's Brochure).
- Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
- Systemic corticosteroid therapy as follows:
- Continuous use with a dosage equivalent to > 15 mg/day of oral prednisone for 90 days preceding vaccination
- Sporadic use with a dose of > 40 mg/day of oral prednisone for > 14 days in the 90 days preceding vaccination.
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 |
|---|---|---|
| Split, Inactivated, Trivalent Influenza VaccineAlso: Fluzone0.1 mL, Intradermal | Biological | Fluzone Intradermal (ID) Vaccine Group |
| Split, Inactivated, Trivalent Influenza VaccineAlso: Fluzone® 2006/2007 Formulation0.5 mL, Intramuscular | Biological | Fluzone Intramuscular (IM) Vaccine Group |
Primary outcome
Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Time frame: Pre-vaccination and Day 28 post-vaccination
The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Time frame: Day 28 post-vaccination
Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40
2 secondary outcomes
Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
Time frame: Pre- and Day 28 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Time frame: Day 0 up to 7 days post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Medical Director study director
Sanofi Pasteur Inc.
17 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 Split, Inactivated, Trivalent Influenza Vaccine in people with Orthomyxoviridae Infection and Influenza, run by Sanofi at 17 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 4 inclusion and 22 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 18 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Yes. Results are posted in the registry (first posted 13 Sep 2011). 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?
Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. (time frame: Pre-vaccination and Day 28 post-vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 18 Apr 2012.