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

Condition(s) targeted: Influenza

Intervention: Cold-adapted influenza vaccine trivalent (CAIV-T) (Biological); Trivalent Inactivated Vaccine (TIV) (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: MedImmune LLC

Official(s) and/or principal investigator(s):
Robert Walker, MD, Study Director, Affiliation: MedImmune LLC

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.

Official title: A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: The first episode of a culture-confirmed influenza-illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine, which occurs at least 15 days following receipt of a dose of study vaccine.

Secondary outcome:

The first episode of a culture-confirmed influenza-illness, caused by any community-acquired subtype, which occurs at least 15 days following receipt of a dose of study vaccine.

The first episode in a study subject of a culture-confirmed influenza illness caused by community-acquired virus of each of the subtypes antigenically similar to those contained in the vaccine

The first episode in a study subject of a culture-confirmed influenza illness caused by any community-acquired virus of each of the subtypes.

The first episode of influenza-like illness

Incidence of clinic visits

Incidence of hospitalization

Incidence of confirmed pneumonia

Incidence of death due to influenza-like illness

Incidence of seroconversion

Incidence of systemic reactogenicity events

Incidence of local reactions

Incidence of adverse events

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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.

Jansen van Rensburg, Amanzimtoti, South Africa

Christiaan Tertius de Villiers, Scottburgh South, South Africa

Docnor House, Durban North, Dwazulu Natal, South Africa

Hazelmed Family Practice, Hazelwood, Pretoria, South Africa

Starting date: March 2002
Last updated: March 13, 2012