trial to compare the safety, tolerability, and efficacy of influenza virus vaccine, (caiv-t) with inactivated, influenza vaccine, trivalent, types a & b, in adults aged 60 years and older against culture-confirmed influenza

Conditions: Influenza

Summary: to demonstrate that the efficacy over a defined surveillance period against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in adults aged at least 60 years at enrollment, of a single intranasally (in) -administered dose of a liquid formulation of influenza virus vaccine,(caiv-t) is non inferior compared with that of a single dose of commercially available influenza vaccine inactivated (tiv) administered intramuscularly (im) prior to the anticipated commencement of the influenza season.


Eligibility criteria:
inclusion criteria: * who are 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; * 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 november 30th, 2003); * 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 influenza study specific manual). an ambulatory subject who is a resident of a retirement home or village is eligible for the trial; * with any signs of renal insufficiency requiring supportive therapy or progressive neurological disease. (subjects with other 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). * with evidence of dementia or other severe cognitive impairment based on mini mental state examination (mmse) scores (refer to influenza study specific 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 caiv-t or tiv vaccine; * who were administered any live virus vaccine within one month prior to vaccination 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 prior to enrollment, or intend to receive a non-study influenza vaccine after 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.