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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00192153
First Posted: September 19, 2005
Last Update Posted: October 25, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
MedImmune LLC
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Robert Walker, MD MedImmune LLC
  More Information

ClinicalTrials.gov Identifier: NCT00192153     History of Changes
Other Study ID Numbers: D153 P003
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: October 25, 2006
Last Verified: October 2006

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases