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 - Full Text View

Sponsors and Collaborators:	MedImmune LLC Wyeth
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00192153

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: CAIV-T or TIV	Phase II

MedlinePlus related topics: Flu

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

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.

Estimated Enrollment:	240
Study Start Date:	July 2001
Estimated Study Completion Date:	October 2001

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192153

Locations

United States, Florida
West Coast Medical Associates
New Port Richey, Florida, United States, 34652
United States, Virginia
University of VA Health Sciences Center
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

MedImmune LLC

Wyeth

Investigators

Principal Investigator:

Robert Walker, MD

MedImmune LLC

More Information

No publications provided

Study ID Numbers:	D153 P003
Study First Received:	September 12, 2005
Last Updated:	October 23, 2006
ClinicalTrials.gov Identifier:	NCT00192153 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009