Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00391391
First received: October 23, 2006
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

Primary Objective:

To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Secondary Objectives:

  • To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
  • To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Condition Intervention Phase
Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Biological: Split, Inactivated, Trivalent Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Healthy Infants and Young Children.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine [ Time Frame: Day 0 and Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.


Secondary Outcome Measures:
  • Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

  • Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]

    Seroprotection was defined as participants achieving a post-dose antibody titers ≥40.

    Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.


  • Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer < 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.

  • Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months. [ Time Frame: Day 0 to Day 7 post-vaccination ] [ Designated as safety issue: No ]
    Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.

  • Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds [ Time Frame: Day 0 to Day 7 post-vaccination ] [ Designated as safety issue: No ]
    Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.


Enrollment: 520
Study Start Date: October 2006
Study Completion Date: October 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Split, Inactivated, Trivalent Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine
Vaccine (infant dose)
Experimental: 2
Split, Inactivated, Trivalent Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine
Vaccine (children dose)
Active Comparator: 3
Split, Inactivated, Trivalent Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Vaccine (infant dose)
Other Name: Fluzone® 2006/2007 Formulation.
Active Comparator: 4
Split, Inactivated, Trivalent Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Vaccine (children dose)
Other Name: Fluzone® 2006/2007 Formulation.

  Eligibility

Ages Eligible for Study:   6 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged 6 months to 8 years but not yet 9 years on the day of inclusion.
  • Subject is healthy, as determined by medical history.
  • Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved informed consent form signed by the subject's parent(s) or legal representative (and by an independent witness if required by local regulations).
  • Parent or legal guardian willing and able to attend (bring subject) to all scheduled visits and comply with all trial procedures.

Exclusion Criteria :

  • Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Personal or family history of Guillain-Barré Syndrome.
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
  • Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a vaccine containing the same substances.
  • Chronic illness at a stage that could interfere with trial conduct or completion
  • Received blood or blood-derived products in the previous 3 months.
  • Any vaccination in the 4 weeks preceding or following the trial vaccinations (Subjects can take standard childhood vaccination(s) following Visit 3 blood draw).
  • Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
  • Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
  • Acute medical illness, with or without fever, within the last 72 hours or an oral temperature ≥ 37.5 °C (99.5 °F) or rectal temperature of ≥ 38°C (100.4 °F) at the time of enrollment.
  • History of seizures.
  • Received antibiotics therapy within 72 hours preceding the trial vaccination.
  • Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination.
  • Any condition, which in the opinion of the investigator would pose a health risk to the participant.
  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: NCT00391391

Locations
United States, Arkansas
Harrisburg, Arkansas, United States, 72432
Little Rock, Arkansas, United States, 72205
Trumann, Arkansas, United States, 72472
United States, California
Bellflower, California, United States, 90706
Downey, California, United States, 90241
Fountain Valley, California, United States, 92708
Paramount, California, United States, 90723
United States, Kentucky
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Bossier City, Louisiana, United States, 71111
Shreveport, Louisiana, United States, 71105
United States, Minnesota
Brainerd, Minnesota, United States, 56401
United States, Ohio
Cleveland, Ohio, United States, 44121
United States, Pennsylvania
Erie, Pennsylvania, United States, 16505
Pittsburgh, Pennsylvania, United States, 15277
Uniontown, Pennsylvania, United States, 15401
Wexford, Pennsylvania, United States, 15090
United States, Texas
Fort Worth, Texas, United States, 76107
United States, Utah
Salt Lake City, Utah, United States, 84109
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00391391     History of Changes
Other Study ID Numbers: FID07
Study First Received: October 23, 2006
Results First Received: October 12, 2011
Last Updated: November 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Orthomyxoviruses
Inactivated Split-virion influenza vaccine
Infants
children.

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

ClinicalTrials.gov processed this record on July 20, 2014