Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine,(CAIV-T)

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192231
First received: September 12, 2005
Last updated: October 23, 2006
Last verified: October 2006
  Purpose

The primary objective of this study was to perform a variety of immunological assays on blood, serum, nasal wash samples, and cells obtained from healthy adult subjects for the purpose 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).


Condition Intervention Phase
Influenza
Biological: CAIV-T
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 and Older

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • The safety objective was to assess the safety and tolerability of CAIV-T vaccine.

Estimated Enrollment: 120
Study Start Date: April 2001
Estimated Study Completion Date: June 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
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 sterilized 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, were 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:

  • 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) score of 22 or greater. Note: Administration of MMSE was performed only if clinically indicated.

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 received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study.
  • 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 or placebo.
  • Subjects who were administered any live virus vaccine within one month prior to enrollment.
  • Subjects for whom there was intent to administer any other investigational vaccine or agent from one month prior to enrollment through the conclusion of the study.
  • Subjects who received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. Prophylactic use of influenza antivirals was not permitted.
  • Subjects who received any influenza vaccine in the six months prior to enrollment, or nonstudy influenza vaccine since enrollment.
  • Subjects with any medical conditions that in the opinion of the investigator might interfere with the interpretation of the study results.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192231

Locations
Australia, Victoria
Austin & Repatriation Medical Centre
Heidelburg, Victoria, Australia, 3084
Sponsors and Collaborators
MedImmune LLC
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Robert Walker, MD MedImmune LLC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192231     History of Changes
Other Study ID Numbers: D153 P510
Study First Received: September 12, 2005
Last Updated: October 23, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014