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Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold- Adapted (CAIV-T) in Healthy Children Attending Day Care Centers

Primary Purpose

Influenza

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

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

6 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: who are aged at least 6 months and less than 36 months of age at the time of enrollment, attending day care for at least three days a week, four hours a day; who are in good health as determined by medical history, physical examination and clinical judgement; whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained; who, along with their parent(s)/legal guardian(s), will be available for duration of the trial (8 months ± 1 month); whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit]. Exclusion Criteria: whose parent(s)/legal guardian(s) 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; who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study; 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; have an immunosuppressed or an immunocompromised individual living in the same household; who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational); who, in the two weeks prior to entry into this study, received a dose of any influenza treatment (commercial or investigational); with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo; with a clinically confirmed respiratory illness with wheezing within two weeks prior to enrollment; who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study; who were administered any live virus vaccine within one month prior to enrollment or expected to receive another live virus vaccine within one month of vaccination in this study; with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; If any of these criteria are met following enrolment, the subject will be excluded from subsequent vaccine dosing. Note: A pregnant household member is not considered a contraindication to enrollment.

Sites / Locations

  • Tampere University Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

CAIV-T

Placebo

Outcomes

Primary Outcome Measures

The primary endpoint for efficacy is the first episode in a study child of a cultureconfirmed influenza illness.

Secondary Outcome Measures

The secondary endpoint for culture-confirmed influenza illness is the first episode caused by any community-acquired antigenic subtype which occurs following receipt of the second dose of study vaccine or placebo.

Full Information

First Posted
September 12, 2005
Last Updated
April 8, 2009
Sponsor
MedImmune LLC
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00192283
Brief Title
Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold- Adapted (CAIV-T) in Healthy Children Attending Day Care Centers
Official Title
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children Attending Day Care Centers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
April 2002 (Actual)
Study Completion Date
May 2002 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy of the liquid formulation of CAIVT against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months, attending day care centers in Europe. In addition, the trial provides the opportunity to investigate the effect of CAIV-T on acute otitis media, on healthcare resource utilization and economic resources.

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
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
2903 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CAIV-T
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
CAIV-T
Intervention Description
The total single-dose volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A single dose of placebo volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).
Primary Outcome Measure Information:
Title
The primary endpoint for efficacy is the first episode in a study child of a cultureconfirmed influenza illness.
Time Frame
28 days after vaccination
Secondary Outcome Measure Information:
Title
The secondary endpoint for culture-confirmed influenza illness is the first episode caused by any community-acquired antigenic subtype which occurs following receipt of the second dose of study vaccine or placebo.
Time Frame
28 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: who are aged at least 6 months and less than 36 months of age at the time of enrollment, attending day care for at least three days a week, four hours a day; who are in good health as determined by medical history, physical examination and clinical judgement; whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained; who, along with their parent(s)/legal guardian(s), will be available for duration of the trial (8 months ± 1 month); whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit]. Exclusion Criteria: whose parent(s)/legal guardian(s) 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; who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study; 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; have an immunosuppressed or an immunocompromised individual living in the same household; who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational); who, in the two weeks prior to entry into this study, received a dose of any influenza treatment (commercial or investigational); with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo; with a clinically confirmed respiratory illness with wheezing within two weeks prior to enrollment; who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study; who were administered any live virus vaccine within one month prior to enrollment or expected to receive another live virus vaccine within one month of vaccination in this study; with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; If any of these criteria are met following enrolment, the subject will be excluded from subsequent vaccine dosing. 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
Tampere University Medical School
City
Tampere
ZIP/Postal Code
33520
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold- Adapted (CAIV-T) in Healthy Children Attending Day Care Centers

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