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Trial to Investigate Viral Shedding in Healthy Children Vaccinated With Vaccine Virus Liquid (CAIV-T)

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CAIV-T, Liquid
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza

Eligibility Criteria

6 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: children at least 6 months of age and less than or equal to 18 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment; whose parent/legal guardian has provided written informed consent after the nature of the study has been explained; who, along with their parent or legal guardian, will be available for the two month duration of the trial (from enrollment to study completion). Exclusion Criteria: whose parents or legal guardians are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period; with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease; with Down's syndrome or other known cytogenetic disorders; with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; intranasal steroids or cytotoxic agents; 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, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational); 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

  • Monroe Clinic

Outcomes

Primary Outcome Measures

Measurement of influenza-specific immune response following receipt of CAIV-T.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
September 10, 2021
Sponsor
MedImmune LLC
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00192387
Brief Title
Trial to Investigate Viral Shedding in Healthy Children Vaccinated With Vaccine Virus Liquid (CAIV-T)
Official Title
A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate Viral Shedding in Healthy Children (6 Mos and Less Than or Equal to 18 Months of Age) Vaccinated With Two Doses of Liquid Formulation of Influenza Virus Vaccine, Live Cold Adapted (CAIV-T)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2001 (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
The primary objective of this study was to determine the proportion of subjects, seronegative to all three strains of influenza, as defined by a serum hemagglutination inhibition antibodies (HAI) antibody titer of <1:10, who shed each vaccine virus strain following a single dose of CAIV-T.

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
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
CAIV-T, Liquid
Primary Outcome Measure Information:
Title
Measurement of influenza-specific immune response following receipt of CAIV-T.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children at least 6 months of age and less than or equal to 18 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment; whose parent/legal guardian has provided written informed consent after the nature of the study has been explained; who, along with their parent or legal guardian, will be available for the two month duration of the trial (from enrollment to study completion). Exclusion Criteria: whose parents or legal guardians are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period; with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease; with Down's syndrome or other known cytogenetic disorders; with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; intranasal steroids or cytotoxic agents; 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, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational); 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
Monroe Clinic
City
Monroe
State/Province
Wisconsin
ZIP/Postal Code
53566
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Trial to Investigate Viral Shedding in Healthy Children Vaccinated With Vaccine Virus Liquid (CAIV-T)

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