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Clinical Trial Opportunities
5515 Cleveland Avenue, Stevensville MI, 49127, Phone: 269.932.1026
Start Date

Ages Eligible for Study: 6 Months to 35 Months
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes

Inclusion Criteria:
  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
  • A male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Subjects in stable health as determined by investigator's clinical examination and assessment of subject's medical history.
  • Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.

Exclusion Criteria:
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
  • Child in care.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Prior receipt of any seasonal or pandemic influenza vaccine within six months preceding the first dose of study vaccine, or planned use during the study period.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Acute disease and/or fever at the time of enrollment.
  • Fever is defined as temperature = 38.0°C/100.4°F by any method.
  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.

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For further information participants can contact our Research Department at (269) 429-6604 ext. 1881 or (269) 932-1026

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