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

Condition(s) targeted: Orthomyxoviridae Infection; Influenza; Myxovirus Infection

Intervention: 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) (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.

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.

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Secondary outcome:

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

Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

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.

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

Minimum age: 6 Months. Maximum age: 8 Years. Gender(s): Both.

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.

Harrisburg, Arkansas 72432, United States

Little Rock, Arkansas 72205, United States

Trumann, Arkansas 72472, United States

Bellflower, California 90706, United States

Downey, California 90241, United States

Fountain Valley, California 92708, United States

Paramount, California 90723, United States

Owensboro, Kentucky 42303, United States

Bossier City, Louisiana 71111, United States

Shreveport, Louisiana 71105, United States

Brainerd, Minnesota 56401, United States

Cleveland, Ohio 44121, United States

Erie, Pennsylvania 16505, United States

Pittsburgh, Pennsylvania 15277, United States

Uniontown, Pennsylvania 15401, United States

Wexford, Pennsylvania 15090, United States

Fort Worth, Texas 76107, United States

Salt Lake City, Utah 84109, United States

Salt Lake City, Utah 84121, United States

Starting date: October 2006
Last updated: November 21, 2011