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 (FluMist)
Influenza
About this trial
This is an interventional prevention trial for Influenza
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.
Sites / Locations
- Docnor House
- Hazelmed Family Practice
- Jansen van Rensburg
- Christiaan Tertius de Villiers
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cold-adapted influenza vaccine trivalent (CAIV-T)
Trivalent Inactivated Vaccine (TIV)
A single 0.2 mL dose of 10^7 fluorescent focus units was administered intranasally.
A single dose was administered by intramuscular injection.