Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza; Myxovirus Infection
Intervention: Split, Inactivated, Trivalent Influenza Vaccine (Biological); Split, Inactivated, Trivalent Influenza Vaccine (Biological); Split, Inactivated, Trivalent Influenza Vaccine (Biological); Split, Inactivated, Trivalent Influenza Vaccine (Biological); Split, Inactivated, Trivalent Influenza Vaccine (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.
Summary
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.
Clinical Details
Official title: 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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Secondary outcome: Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Alabaster, Alabama, United States
Mobile, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fountain Valley, California, United States
San Diego, California, United States
Stanford, Connecticut, United States
Pembroke Pines, Florida, United States
Pinellas Park, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Wichita, Kansas, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
St. Louis, Missouri, United States
Cary, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Allentown, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Warwick, Rhode Island, United States
Goose Creek, South Carolina, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Marshfield, Wisconsin, United States
Additional Information
Starting date: October 2007
Last updated: October 13, 2011
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