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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Myxovirus Infection; Influenza; Orthomyxoviridae Infection

Treatments: Biological: Split, Inactivated, Trivalent Influenza Vaccine; Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00391391

FID07

Details and patient eligibility

About

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.

Enrollment: 520 patients

Sex: All

Ages: 6 months to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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520 participants in 4 patient groups

1

Experimental group

Description:

Split, Inactivated, Trivalent Influenza Vaccine

Treatment:

Biological: Split, Inactivated, Trivalent Influenza Vaccine

Biological: Split, Inactivated, Trivalent Influenza Vaccine

2

Experimental group

Description:

Split, Inactivated, Trivalent Influenza Vaccine

Treatment:

Biological: Split, Inactivated, Trivalent Influenza Vaccine

Biological: Split, Inactivated, Trivalent Influenza Vaccine

3

Active Comparator group

Description:

Split, Inactivated, Trivalent Influenza Vaccine

Treatment:

Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

4

Active Comparator group

Description:

Split, Inactivated, Trivalent Influenza Vaccine

Treatment:

Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)