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

NCT ID: NCT00192192

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2000-12-31

Brief Summary

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).

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

CAIV-T

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Principal Investigators

Robert Walker, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Stamford Hospital

Stamford, Connecticut, United States

Countries

United States

Other Identifiers

D153 P001

Identifier Type: -

Identifier Source: org_study_id