Clinical trial NCT00217230: Trial To Assess Safety And Efficacy Of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) In Adults Aged 60 Years And Older
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial To Assess Safety And Efficacy Of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) In Adults Aged 60 Years And Older CAIV-T, Liquid Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-09-22
Enrollment: 3000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy, safety and tolerability of the liquid formulation of CAIV-T against culture confirmed influenza illness in adults aged 60 years and older. In addition this study aims to demonstrate superiority of CAIV-T when compared with placebo and the effect on economic resources.

Detailed description: To evaluate the efficacy over 1 year against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in adults aged ≥ 60 years at enrollment, of 1 dose of an intranasally-administered (IN) liquid formulation of influenza virus vaccine, trivalent, types A and B, live, cold-adapted (CAIV-T; Wyeth, Marietta, PA, USA) compared with saline placebo.

Eligibility criteria: Inclusion Criteria:

* who are and 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. Subjects with 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.
* 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 approximately November 30, 2001); 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 study manual). An ambulatory subject who is a resident of a retirement home or village is eligible for the trial.
* With evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) scores (refer to study 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 study vaccine or placebo;
* who were administered any live virus vaccine within one month prior to enrollment 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 to enrollment, or a non-study influenza vaccine since 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

Primary outcomes:
measure: The primary study endpoint was the comparison of efficacy of CAIV-T versus placebo against culture-confirmed influenza-illness caused by community-acquired influenza subtypes that were antigenically similar to those contained in the vaccine.
Secondary outcomes:
measure: A secondary comparison of interest was the incidence of culture-confirmed influenza-illness caused by any antigenic subtype.
Other outcomes:
Locations:
city: Tygerberg
country: South Africa
facility: Department of Family & Primary Care, Faculty of Medicine, University of Stellenbosch
Study officials:
affiliation: Dept of Family Medicine & Primary Care, University of Stellenbosch
name: Pjt de Villiers, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Villiers PJ, Steele AD, Hiemstra LA, Rappaport R, Dunning AJ, Gruber WC, Forrest BD; LAIV Elderly Study Trial Network. Efficacy and safety of a live attenuated influenza vaccine in adults 60 years of age and older. Vaccine. 2009 Dec 10;28(1):228-34. doi: 10.1016/j.vaccine.2009.09.092. Epub 2009 Sep 29.