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Sponsors and Collaborators: |
MedImmune LLC Wyeth |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00217230 |
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 |
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Influenza |
Biological: CAIV-T |
Phase III |
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 |
Estimated Enrollment: | 3000 |
Study Start Date: | April 2001 |
Estimated Study Completion Date: | November 2001 |
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.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
South Africa | |
Department of Family & Primary Care, Faculty of Medicine, University of Stellenbosch | |
Tygerberg, South Africa, 7505 |
Principal Investigator: | Pjt de Villiers, Professor | Dept of Family Medicine & Primary Care, University of Stellenbosch |
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 |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |