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Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold Adapted (CAIV-T) in Healthy Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00192192
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
To perform a variety of assays on blood, serum, nasal wash samples and cells obtained from healthy adult subjects for the purposes of developing assays for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA).

Condition Intervention Phase
Influenza Biological: CAIV-T Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold Adapted (CAIV-T) in Healthy Adults Aged 18 to 64 Years

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Assays on blood, serum, nasal wash samples and cells obtained from healthy adult subjects

Estimated Enrollment: 20
Study Start Date: November 2000
Estimated Study Completion Date: December 2000
  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 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • who are between 18 to 64 years of age. Subject must be at least 18 years of age and no older than 64 years of age at the time informed consent is obtained;
  • eligible female subjects, who are of childbearing potential, who have a negative urine pregnancy test results prior to study vaccination. Females who are surgically sterile or post-menopausal do not require pregnancy testing.
  • who are determined by medical history, physical examination and clinical judgement to be 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.
  • who have provided written informed consent after the nature of the study has been explained;
  • who, will be available for two month duration of the trial (from enrollment to study completion);
  • who can be reached by study staff for the post-vaccination contact [telephone, clinic or home visit]

Exclusion Criteria:

  • who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period
  • with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents;
  • who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
  • have an immunosuppressed or an immunocompromised individual living in the same household;
  • with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
  • who were administered any live virus vaccine within one month prior to enrollment;
  • for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
  • who, received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. The prophylactic use of influenza antivirals is not permitted.
  • who receive any influenza vaccine in the 6 months prior to enrollment, or a non-study influenza vaccine since enrollment;
  • with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; Note: A pregnant household member is not considered a contraindication to enrollment.
  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): NCT00192192


Locations
United States, Connecticut
Stamford Hospital
Stamford, Connecticut, United States, 06904
Sponsors and Collaborators
MedImmune LLC
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Robert Walker, MD MedImmune LLC
  More Information

ClinicalTrials.gov Identifier: NCT00192192     History of Changes
Other Study ID Numbers: D153 P001
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