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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
This study has been completed.
Sponsors and Collaborators: MedImmune LLC
Wyeth
Information provided by: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00217230
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: CAIV-T
Phase III

MedlinePlus related topics: Flu
Drug Information available for: Influenza Vaccines Fluvirin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
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

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • A secondary comparison of interest was the incidence of culture-confirmed influenza-illness caused by any antigenic subtype.

Estimated Enrollment: 3000
Study Start Date: April 2001
Estimated Study Completion Date: November 2001
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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217230

Locations
South Africa
Department of Family & Primary Care, Faculty of Medicine, University of Stellenbosch
Tygerberg, South Africa, 7505
Sponsors and Collaborators
MedImmune LLC
Wyeth
Investigators
Principal Investigator: Pjt de Villiers, Professor Dept of Family Medicine & Primary Care, University of Stellenbosch
  More Information

Study ID Numbers: D153-P507
Study First Received: September 12, 2005
Last Updated: October 2, 2006
ClinicalTrials.gov Identifier: NCT00217230  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009