Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

who are and aged at least 60 years or older at the time of enrollment;
who are determined by medical history, physical examination and clinical judgement to be 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 will be eligible.
who have provided written informed consent after the nature of the study has been explained;
who, will be available for duration of the trial (from enrollment to approximately November 30, 2001); who can be reached by study staff for the post-vaccination and weekly surveillance contacts [telephone, clinic or home visit].

Exclusion Criteria:

who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
who are a resident of a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care (refer to study manual). An ambulatory subject who is a resident of a retirement home or village is eligible for the trial.
With evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) scores (refer to study manual).
with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents;
who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
have an immunosuppressed or an immunocompromised individual living in the same household;
with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
who were administered any live virus vaccine within one month prior to enrollment or expected to receive another live virus vaccine within one month of vaccination in this study;
for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
who, received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. The prophylactic use of influenza antivirals is not permitted.
who receive any influenza vaccine in the 6 months to enrollment, or a non-study influenza vaccine since enrollment;
with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; Note: A pregnant household member is not considered a contraindication to enrollment