Status:
COMPLETED
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
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Influenza
Eligibility:
All Genders
60+ years
Phase:
PHASE3
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 ad...
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 year...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
End Date :
November 1 2001
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT00217230
Start Date
April 1 2001
End Date
November 1 2001
Last Update
October 3 2006
Active Locations (1)
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1
Department of Family & Primary Care, Faculty of Medicine, University of Stellenbosch
Tygerberg, South Africa, 7505