- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00551031
Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects
Immunogenicity and Safety of Two Dosages of the Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in the Elderly Compared With Standard Fluzone® in Adults and Elderly Subjects.
The present formulations are being developed for further study in the elderly population in order to generate additional supporting data.
Primary Objective:
To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects.
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 Overview
Status
Conditions
Intervention / Treatment
- Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)
- Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)
- Biological: Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
- Biological: Split, Inactivated, Trivalent Influenza Vaccine (High-dose)
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Alabaster, Alabama, United States
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Mobile, Alabama, United States
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Arizona
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Chandler, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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California
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Fountain Valley, California, United States
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San Diego, California, United States
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Connecticut
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Stanford, Connecticut, United States
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Florida
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Pembroke Pines, Florida, United States
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Pinellas Park, Florida, United States
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Idaho
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Boise, Idaho, United States
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Illinois
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Chicago, Illinois, United States
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Kansas
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Wichita, Kansas, United States
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Missouri
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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St. Louis, Missouri, United States
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North Carolina
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Cary, North Carolina, United States
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Raleigh, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Pennsylvania
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Allentown, Pennsylvania, United States
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Bensalem, Pennsylvania, United States
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Rhode Island
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Warwick, Rhode Island, United States
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South Carolina
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Goose Creek, South Carolina, United States
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Texas
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Fort Worth, Texas, United States
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Galveston, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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West Jordan, Utah, United States
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Wisconsin
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Marshfield, Wisconsin, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged ≥ 65 years or aged 18 to 49 years on the day of vaccination.
- Informed consent form signed.
- Medically stable (Subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as their symptoms/signs are controlled. If they are on medication for a condition, the medication dose must have been stable for at least 3 weeks preceding vaccination.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination
Exclusion Criteria:
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the standard-dose Fluzone® vaccine or to a vaccine containing any of the same substances.
- Known or suspected congenital or acquired immunodeficiency, hepatitis B (HBsAg) or hepatitis C infection or seropositivity immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test.
- Breast feeding woman.
- 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 use of alcohol or recreational drugs that in the opinion of the Investigator may interfere with the subject's ability to comply with trial procedures.
- Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
- Vaccination against influenza in the past 6 months.
- Any vaccination in the 4 weeks preceding the trial vaccination.
- Planned receipt of any other vaccine in the four weeks following the trial vaccination.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination.
- Planned participation in another clinical trial during the present trial period.
Note: Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable.
- Known thrombocytopenia or bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- Personal or family history of Guillain-Barré Syndrome.
- Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- An acute febrile illness [oral temperature ≥ 99.5°F (≥ 37.5°C)] within 24 hours prior to vaccination. If this exists, vaccination will be deferred until the participant becomes afebrile.
- Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve.
- The use of an antibiotics therapy within 72 hours preceding the trial vaccination. If this exists, vaccination will be deferred until at least 72 hours after the last antibiotics therapy.
- Receipt of any allergy shots in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots in the 7-day period after enrollment (vaccination). Subjects should be enrolled in the trial only if their allergy shots are given on a stable schedule outside the 7-day periods pre- and post-vaccination.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Influenza Virus Vaccine Formulation 1
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0.1 mL, Intradermal (ID)
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EXPERIMENTAL: Influenza Virus Vaccine Formulation 2
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0.1 mL, Intradermal (ID)
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ACTIVE_COMPARATOR: Fluzone® Elderly Group
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0.5 mL, Intramuscular (IM)
Other Names:
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ACTIVE_COMPARATOR: Fluzone® High-dose Group
Participants enrolled at age ≥ 65 years
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0.5 mL, Intramuscular (IM)
Other Names:
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ACTIVE_COMPARATOR: Fluzone® Adults Group
Participants enrolled at age 18-49 years.
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0.5 mL, Intramuscular (IM)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Time Frame: Day 0 and Day 28 post vaccination
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Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.
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Day 0 and Day 28 post vaccination
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Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine
Time Frame: Day 28 post-vaccination
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Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.
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Day 28 post-vaccination
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Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Time Frame: Day 0 and Day 28 post-vaccination
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Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40
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Day 0 and Day 28 post-vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Time Frame: Days 0 through 7 post-vaccination
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Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills |
Days 0 through 7 post-vaccination
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FID29
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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