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

NCT ID: NCT00192153

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31
• Study Completion Date: 2001-10-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

CAIV-T or TIV

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Principal Investigators

Robert Walker, MD

Role: PRINCIPAL_INVESTIGATOR

MedImmune LLC

Locations

West Coast Medical Associates

New Port Richey, Florida, United States

University of VA Health Sciences Center

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

D153 P003

Identifier Type: -

Identifier Source: org_study_id