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

Influenza Clinical Trial

Official title:

A Randomized, Partially-Blinded, Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, (CAIV-T) in Healthy Adults 18 to 59 Years and Healthy Adults,60 Years/Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192153
• Other study ID #: D153 P003
• Status: Completed
• Phase: Phase 2
• Start date: July 2001
• Est. completion date: October 2001

Study information

• Verified date: October 2006
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• CAIV-T or TIV

Locations

Country	Name	City	State
United States	University of VA Health Sciences Center	Charlottesville	Virginia
United States	West Coast Medical Associates	New Port Richey	Florida

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.