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)

MedImmune

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Cold-adapted influenza vaccine trivalent (CAIV-T)

Biological: Trivalent Inactivated Vaccine (TIV)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00192413

D153-P516

Details and patient eligibility

About

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.

Enrollment

3,009 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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.