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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

Page last updated: August 20, 2015

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