InfluenzaPhase 2NCT00775450
Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
A Phase 2 study testing Influenza Virus Vaccine USP Trivalent Types A and B in people with Influenza and Orthomyxovirus Infection, run by Sanofi Pasteur, a Sanofi Company at 28 sites in United States.
Trial summary
This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years. Primary Objective: To describe the safety profile for all subjects. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Orthomyxovirus Infection, Myxovirus Infection
- What is being tested?
- Influenza Virus Vaccine USP Trivalent Types A and B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 807 participants
- Where
- 28 sitesUnited States
- Study dates
- Oct 2008to Jul 2009
- 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
- Enrolled in and completed study FID29 and received the correct vaccine for the group to which they were randomized
- Informed consent form signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures
- Subject is medically stable.
Who cannot join
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
Show all 15Show fewer
- Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- Receipt of any vaccination in the 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- Known human immunodeficiency virus (HIV), hepatitis B (HBs) antigen, or Hepatitis C seropositivity.
- Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- 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).
- Personal or family history of Guillain-Barré Syndrome.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Study site
Bensalem, Pennsylvania, 19020
Study site
Cary, North Carolina, 27518
Study site
Chandler, Arizona, 85224
Study site
Chicago, Illinois, 60610
Study site
Cincinnati, Ohio, 45249
Study site
Fort Worth, Texas, 76107
Study site
Fountain Valley, California, 92708
Study site
Galveston, Texas, 77555
Study site
Hoover, Alabama, 35216
Study site
Kansas City, Missouri, 64114
Study site
Marshfield, Wisconsin, 54449
Study site
Mesa, Arizona, 85213
Study site
Milford, Connecticut, 06460
Study site
Mobile, Alabama, 36608
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Pembroke Pines, Florida, 33024
Study site
Phoenix, Arizona, 85014
Study site
Pinellas Park, Florida, 33781
Study site
Raleigh, North Carolina, 27609
Study site
Salt Lake City, Utah, 84109
Study site
Salt Lake City, Utah, 84121
Study site
San Diego, California, 92103
Study site
Springfield, Missouri, 65802
Study site
St Louis, Missouri, 63110
Study site
Tucson, Arizona, 85710
Study site
Warwick, Rhode Island, 02886
Study site
West Jordan, Utah, 84088
Study site
Wichita, Kansas, 67207
About this study
Official title: Safety and Immunogenicity of Revaccination With Influenza Vaccine in Ambulatory Elderly Subjects Previously Vaccinated With Fluzone ID, Fluzone HD, and Fluzone® IM
This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.
Primary Objective:
To describe the safety profile for all subjects.
Secondary Objective:
To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
Read the detailed description
Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.
- Conditions
- Influenza, Orthomyxovirus Infection, Myxovirus Infection
- Being tested
- Influenza Virus Vaccine USP Trivalent Types A and B
- Keywords
- Influenza, Orthomyxovirus Infection, Inactivated Split-virion influenza vaccine, Elderly
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Virus Vaccine USP Trivalent Types A and BBiological
Also called Fluzone
0.1 mL, Intradermal
Influenza Virus Vaccine USP Trivalent Types A and BBiological
Also called Fluzone
0.5 mL, Intramuscular
Influenza Virus Vaccine USP Trivalent Types A and BBiological
Also called Fluzone
0.5 mL, Intramuscular
Influenza Virus Vaccine USP Trivalent Types A and BBiological
Also called Fluzone
0.1 mL, Intradermal
Influenza Virus Vaccine USP Trivalent Types A and BBiological
Also called Fluzone
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1a: Fluzone ID After Fluzone ID | Experimental | Not described Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B |
| Group 1b: Fluzone IM After Fluzone ID | Experimental | Not described Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B |
| Group 2a: Fluzone IM After Fluzone IM | Active comparator | Not described Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B |
| Group 2b: Fluzone ID After Fluzone IM | Experimental | Not described Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B |
| Group 3: Fluzone HD After Fluzone HD | Active comparator | Not described Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.
Measured: Days 0 through 7 post vaccination
Secondary outcomes (3)
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.
Measured: Day 0 and Day 28 post-vaccination
Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.
Measured: Days 0 and 28 post-vaccination
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.
Measured: Day 28 post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJul 2009
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 InfluenzaStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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
- 807 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775450
- Sponsor's protocol ID
- FID21
- Status last verified
- Dec 2013
- First submitted
- 16 Oct 2008
- Last updated
- 31 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Revaccination With Influenza Vaccine in Ambulatory Elderly Subjects Previously Vaccinated With Fluzone ID, Fluzone HD, and Fluzone® IM
- ClinicalTrials.gov ID
- NCT00775450
- Acronym / sponsor ID
- FID21
- Conditions
- Influenza, Orthomyxovirus Infection, Myxovirus Infection
- Keywords
- Influenza, Orthomyxovirus Infection, Inactivated Split-virion influenza vaccine, Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 807 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Posted 11 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.
Primary Objective:
To describe the safety profile for all subjects.
Secondary Objective:
To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
Detailed description
Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1a: Fluzone ID After Fluzone ID | Experimental | Biological: Influenza Virus Vaccine USP Trivalent Types A and B |
| Group 1b: Fluzone IM After Fluzone ID | Experimental | Biological: Influenza Virus Vaccine USP Trivalent Types A and B |
| Group 2a: Fluzone IM After Fluzone IM | Active comparator | Biological: Influenza Virus Vaccine USP Trivalent Types A and B |
| Group 2b: Fluzone ID After Fluzone IM | Experimental | Biological: Influenza Virus Vaccine USP Trivalent Types A and B |
| Group 3: Fluzone HD After Fluzone HD | Active comparator | Biological: Influenza Virus Vaccine USP Trivalent Types A and B |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged ≥ 65 years on the day of vaccination
- Enrolled in and completed study FID29 and received the correct vaccine for the group to which they were randomized
- Informed consent form signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures
- Subject is medically stable.
Key exclusion criteria (15 listed)
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
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 |
|---|---|---|
| Influenza Virus Vaccine USP Trivalent Types A and BAlso: Fluzone0.1 mL, Intradermal | Biological | Group 1a: Fluzone ID After Fluzone ID |
| Influenza Virus Vaccine USP Trivalent Types A and BAlso: Fluzone0.5 mL, Intramuscular | Biological | Group 1b: Fluzone IM After Fluzone ID |
| Influenza Virus Vaccine USP Trivalent Types A and BAlso: Fluzone0.5 mL, Intramuscular | Biological | Group 2a: Fluzone IM After Fluzone IM |
| Influenza Virus Vaccine USP Trivalent Types A and BAlso: Fluzone0.1 mL, Intradermal | Biological | Group 2b: Fluzone ID After Fluzone IM |
| Influenza Virus Vaccine USP Trivalent Types A and BAlso: Fluzone0.5 mL, Intramuscular | Biological | Group 3: Fluzone HD After Fluzone HD |
Primary outcome
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Time frame: Days 0 through 7 post vaccination
Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.
3 secondary outcomes
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
Time frame: Day 0 and Day 28 post-vaccination
Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
Time frame: Days 0 and 28 post-vaccination
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
Time frame: Day 28 post vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
- 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 Monitor study director
Sanofi Pasteur Inc.
28 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 Influenza Virus Vaccine USP Trivalent Types A and B in people with Influenza and Orthomyxovirus Infection, run by Sanofi Pasteur, a Sanofi Company at 28 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 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 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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 11 Aug 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 Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection (time frame: Days 0 through 7 post vaccination). 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 31 Dec 2013; AzTrials last refreshed its copy on 7 Nov 2026.