trial to assess safety and efficacy of influenza virus vaccine, trivalent, types a & b, live cold-adapted (caiv-t) in adults aged 60 years and older

Conditions: Influenza

Summary: the purpose of this study is to determine the efficacy, safety and tolerability of the liquid formulation of caiv-t against culture confirmed influenza illness in adults aged 60 years and older. in addition this study aims to demonstrate superiority of caiv-t when compared with placebo and the effect on economic resources.

to evaluate the efficacy over 1 year against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in adults aged ≥ 60 years at enrollment, of 1 dose of an intranasally-administered (in) liquid formulation of influenza virus vaccine, trivalent, types a and b, live, cold-adapted (caiv-t; wyeth, marietta, pa, usa) compared with saline placebo.

Eligibility 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