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

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.

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.

Study Overview

• Status: Completed
• Conditions: Influenza; Orthomyxoviridae Infection; Myxovirus Infection
• Intervention / Treatment: Biological: Split, Inactivated, Trivalent Influenza Vaccine; Biological: Split, Inactivated, Trivalent Influenza Vaccine; Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation); Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Harrisburg, Arkansas, United States, 72432
    • Little Rock, Arkansas, United States, 72205
    • Trumann, Arkansas, United States, 72472
  • California
    • Bellflower, California, United States, 90706
    • Downey, California, United States, 90241
    • Fountain Valley, California, United States, 92708
    • Paramount, California, United States, 90723
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
    • Shreveport, Louisiana, United States, 71105
  • Minnesota
    • Brainerd, Minnesota, United States, 56401
  • Ohio
    • Cleveland, Ohio, United States, 44121
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16505
    • Pittsburgh, Pennsylvania, United States, 15277
    • Uniontown, Pennsylvania, United States, 15401
    • Wexford, Pennsylvania, United States, 15090
  • Texas
    • Fort Worth, Texas, United States, 76107
  • Utah
    • Salt Lake City, Utah, United States, 84121
    • Salt Lake City, Utah, United States, 84109

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Split, Inactivated, Trivalent Influenza Vaccine	Biological: Split, Inactivated, Trivalent Influenza Vaccine; Vaccine (infant dose); Biological: Split, Inactivated, Trivalent Influenza Vaccine; Vaccine (children dose)
Experimental: 2; Split, Inactivated, Trivalent Influenza Vaccine	Biological: Split, Inactivated, Trivalent Influenza Vaccine; Vaccine (infant dose); 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 Names: Fluzone® 2006/2007 Formulation.; Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation); Vaccine (children dose); Other Names: Fluzone® 2006/2007 Formulation.
Active Comparator: 4; Split, Inactivated, Trivalent Influenza Vaccine	Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation); Vaccine (infant dose); Other Names: Fluzone® 2006/2007 Formulation.; Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation); Vaccine (children dose); Other Names: Fluzone® 2006/2007 Formulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.	Day 0 and Day 28 post-vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.	Day 28 post-vaccination
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	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.	Day 28 post-vaccination
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	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.	Day 28 post-vaccination
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.	Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.	Day 0 to Day 7 post-vaccination
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	Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.	Day 0 to Day 7 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: October 23, 2006
• First Submitted That Met QC Criteria: October 23, 2006
• First Posted (Estimate): October 24, 2006

Study Record Updates

• Last Update Posted (Estimate): December 1, 2011
• Last Update Submitted That Met QC Criteria: November 21, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Influenza; Infants; Orthomyxoviruses; Inactivated Split-virion influenza vaccine; children.
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FID07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No