Status:
COMPLETED
Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older Against Culture-confirmed Influenza
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
To demonstrate that the efficacy over a defined surveillance period against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the va...
Eligibility Criteria
Inclusion
- who are 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;
- 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 November 30th, 2003);
- 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 Influenza study specific manual). An ambulatory subject who is a resident of a retirement home or village is eligible for the trial;
- with any signs of renal insufficiency requiring supportive therapy or progressive neurological disease. (Subjects with other 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).
- with evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) scores (refer to Influenza study specific 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 CAIV-T or TIV vaccine;
- who were administered any live virus vaccine within one month prior to vaccination 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 prior to enrollment, or intend to receive a non-study influenza vaccine after 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 :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2002
Estimated Enrollment :
3009 Patients enrolled
Trial Details
Trial ID
NCT00192413
Start Date
March 1 2002
End Date
November 1 2002
Last Update
March 14 2012
Active Locations (4)
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1
Docnor House
Durban North, Dwazulu Natal, South Africa
2
Hazelmed Family Practice
Hazelwood, Pretoria, South Africa
3
Jansen van Rensburg
eManzimtoti, South Africa
4
Christiaan Tertius de Villiers
Scottburgh South, South Africa