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
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
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.
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.