Influenza
Conditions
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 years and older as a means to develop assays for application in investigating potential immunological correlates of protection and/or establishing assays to measure vaccine take.
Interventions
BIOLOGICALCAIV-T or TIV
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To perform a variety of immunological assays using blood, serum, nasal washed an cells for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted. | — |
Countries
United States
Outcome results
None listed