Influenza Clinical Trial
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
Verified date | October 2006 |
Source | MedImmune LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3000 |
Est. completion date | November 2001 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
South Africa | Department of Family & Primary Care, Faculty of Medicine, University of Stellenbosch | Tygerberg |
Lead Sponsor | Collaborator |
---|---|
MedImmune LLC | Wyeth is now a wholly owned subsidiary of Pfizer |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | A secondary comparison of interest was the incidence of culture-confirmed influenza-illness caused by any antigenic subtype. |
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