study of inactivated, split-virion influenza vaccine compared with standard fluzone vaccine in infants and children

Conditions: Orthomyxoviridae Infection; Influenza; Myxovirus Infection

Summary: 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.


Eligibility 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.

Keywords: influenza orthomyxoviruses inactivated split-virion influenza vaccine infants children.