Status:
COMPLETED
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine,(CAIV-T)
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study was to perform a variety of immunological assays on blood, serum, nasal wash samples, and cells obtained from healthy adult subjects for the purpose of developing a...
Eligibility Criteria
Inclusion
- Healthy adults aged 18 to 59 years or \> 60 years.
- Female subjects of childbearing potential who had a negative urine pregnancy test result prior to study vaccination. Females who were surgically sterilized or post-menopausal did not require pregnancy testing.
- Adults who were determined by medical history, physical examination and clinical judgment 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, were eligible.
- Subjects who provided written informed consent after the nature of the study was explained.
- Subjects who were available for the duration of the study (from enrollment to study completion).
- Subjects who could be reached by study staff for the post-vaccination contact \[via telephone, clinic or home visit\].
Exclusion
- Subjects who resided in a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care. An ambulatory subject who resided in a retirement home or village was eligible for participation.
- Subjects with evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) score of 22 or greater. Note: Administration of MMSE was performed only if clinically indicated.
- For all study subjects:
- Subjects who were perceived to be unavailable or difficult to contact for evaluation of study visits during the study period.
- Subjects with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents.
- Subjects who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study.
- Subjects who resided in the same household as an immunosuppressed or immunocompromised individual.
- Subjects with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo.
- Subjects who were administered any live virus vaccine within one month prior to enrollment.
- Subjects for whom there was intent to administer any other investigational vaccine or agent from one month prior to enrollment through the conclusion of the study.
- Subjects who received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. Prophylactic use of influenza antivirals was not permitted.
- Subjects who received any influenza vaccine in the six months prior to enrollment, or nonstudy influenza vaccine since enrollment.
- Subjects with any medical conditions that in the opinion of the investigator might interfere with the interpretation of the study results.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
End Date :
June 1 2001
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00192231
Start Date
April 1 2001
End Date
June 1 2001
Last Update
September 13 2021
Active Locations (1)
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1
Austin & Repatriation Medical Centre
Heidelburg, Victoria, Australia, 3084