Status:
COMPLETED
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine(CAIV-T)in Healthy Adults Aged 18 to 59 and Healthy 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
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this clinical study was to evaluate immune responses measuring antibodies in serum and secretions and cellular immune responses generated by CAIV-T vaccine in healthy adults aged 18 yea...
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 sterile 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, will be 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
- For subjects \> 60 years of age only:
- 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) scores. Note: Prior to study vaccination, all subjects \>60 years of age must have completed a MMSE.
- 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 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, placebo or TIV.
- Subjects who had a current wheezing episode that was considered a change from the subject's usual clinical state.
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
End Date :
October 1 2001
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00192153
Start Date
July 1 2001
End Date
October 1 2001
Last Update
September 13 2021
Active Locations (2)
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1
West Coast Medical Associates
New Port Richey, Florida, United States, 34652
2
University of VA Health Sciences Center
Charlottesville, Virginia, United States, 22908