ABOUT THIS STUDY
- Healthy adults aged 18 to 59 years or > 60 years.
- Female subjects of childbearing potential who had a negative urine pregnancy test result prior to study vaccination. Females who were surgically sterilized or post-menopausal did not require pregnancy testing.
- Adults who were determined by medical history, physical examination and clinical judgment eligible for this study. Subjects with stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination, were eligible.
- Subjects who provided written informed consent after the nature of the study was explained.
- Subjects who were available for the duration of the study (from enrollment to study completion).
- Subjects who could be reached by study staff for the post-vaccination contact [via telephone, clinic or home visit].
- Subjects who resided in a nursing home or long-term care facility or other institution
receiving skilled or semi-skilled nursing care. An ambulatory subject who resided in a
retirement home or village was eligible for participation.
- Subjects with evidence of dementia or other severe cognitive impairment based on Mini
Mental State Examination (MMSE) score of 22 or greater. Note: Administration of MMSE
was performed only if clinically indicated.
For all study subjects:
- Subjects who were perceived to be unavailable or difficult to contact for evaluation
of study visits during the study period.
- Subjects with a known or suspected disease of the immune system or those receiving
immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents.
- Subjects who received any blood products, including immunoglobulin, in the period from
six months prior to vaccination through to the conclusion of the study.
- Subjects who resided in the same household as an immunosuppressed or immunocompromised
- Subjects with a documented history of hypersensitivity to egg or egg protein or any
other component of the study vaccine or placebo.
- Subjects who were administered any live virus vaccine within one month prior to
- Subjects for whom there was intent to administer any other investigational vaccine or
agent from one month prior to enrollment through the conclusion of the study.
- Subjects who received a dose of influenza treatment (commercial or investigational)
one month prior to enrollment. Prophylactic use of influenza antivirals was not
- Subjects who received any influenza vaccine in the six months prior to enrollment, or
nonstudy influenza vaccine since enrollment.
- Subjects with any medical conditions that in the opinion of the investigator might
interfere with the interpretation of the study results.
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