search
Back to results

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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CAIV-T
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Stamford Hospital

Outcomes

Primary Outcome Measures

Assays on blood, serum, nasal wash samples and cells obtained from healthy adult subjects

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
September 10, 2021
Sponsor
MedImmune LLC
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00192192
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
CAIV-T
Primary Outcome Measure Information:
Title
Assays on blood, serum, nasal wash samples and cells obtained from healthy adult subjects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Walker, MD
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs