Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00551031
First received: October 29, 2007
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Influenza
Myxovirus Infection
Biological: Split, Inactivated, Trivalent Influenza Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis.

    Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills



Enrollment: 2098
Study Start Date: October 2007
Study Completion Date: November 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza Virus Vaccine Formulation 1
Influenza Virus Vaccine Formulation 1
Biological: Split, Inactivated, Trivalent Influenza Vaccine
0.1 mL, Intradermal (ID)
Experimental: Influenza Virus Vaccine Formulation 2
Influenza Virus Vaccine Formulation 2
Biological: Split, Inactivated, Trivalent Influenza Vaccine
0.1 mL, Intradermal (ID)
Active Comparator: Fluzone® Elderly Group Biological: Split, Inactivated, Trivalent Influenza Vaccine
0.5 mL, Intramuscular (IM)
Other Name: Fluzone®
Active Comparator: Fluzone® High-dose Group
Participants enrolled at age ≥ 65 years
Biological: Split, Inactivated, Trivalent Influenza Vaccine
0.5 mL, Intramuscular (IM)
Other Name: Fluzone® High-dose
Active Comparator: Fluzone® Adults Group
Participants enrolled at age 18-49 years.
Biological: Split, Inactivated, Trivalent Influenza Vaccine
0.5 mL, Intramuscular (IM)
Other Name: Fluzone®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551031

  Show 29 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00551031     History of Changes
Other Study ID Numbers: FID29
Study First Received: October 29, 2007
Results First Received: October 13, 2011
Last Updated: October 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Orthomyxoviruses
Myxovirus Infection
Inactivated Split-virion influenza vaccine
Elderly

Additional relevant MeSH terms:
Infection
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014