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Study to Evaluate the Immune Responses of Trivalent Cold-Adapted Influenza Vaccine (CAIV-T) Compared With (TIV)

Primary Purpose

Influenza

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

About this trial

This is an interventional treatment trial for Influenza

Eligibility Criteria

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

Inclusion Criteria: Male or Female Ages 6 to but less than 36 months (reached their 6th month but have not yet reached their 3rd birthday) at the time of randomization Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the participant's parent/legal representative Ability of the parent/legal representative to understand and comply with the requirements of the study Parent/legal representative available by telephone Ability to complete follow-up period of 180 days after final study vaccination, as required by the protocol Exclusion Criteria: History of hypersensitivity to any component of CAIV-T or TIV, including egg or egg products, monosodium glutamate, porcine gelatin or thimerosal History of hypersensitivity to gentamicin Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy Household contact who is immunocompromised (participants should also avoid close contact with immunocompromised individuals for at least 21 days after each study vaccination) History of Guillain-Barre syndrome Medically diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled), by parent/legal representative report or chart review, within the 42 days prior to randomization (i.e., children with recent persistent asthma are excluded); or history of severe persistent asthma, according to the criteria described in the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma - Update on Selected Topics 2002 Acute febrile (not greater than 100.0 degrees F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to either study vaccination Use of aspirin or aspirin-containing products within 30 days prior to randomization, or expected use through 180 days after final study vaccination Receipt of any prior influenza vaccine Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to randomization, or expected use through 180 days after final study vaccination Administration of any live virus vaccine within 30 days prior to randomization, or expected receipt through 30 days after final study vaccination Administration of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization, or expected receipt within 14 days before, or 14 days after, either study vaccination Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 180 days after final study vaccination (use of licensed agents for indications not listed in the package insert is permitted) Receipt of any blood product within 90 days prior to randomization, or expected receipt through 180 days after final study vaccination Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study Any condition that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of the study results

Sites / Locations

  • Wee Care Pediatrics
  • Bear Care Pediatrics
  • Alpine Pediatrics
  • Utah Valley Pediatrics
  • Families First Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

1

2

Arm Description

CAIV-T

TIV

Outcomes

Primary Outcome Measures

The following immunogenicity endpoints: The strain-specific HAI seroconversion rates (≥ 4-fold increase) among baseline seronegative participants (HAI titer ≤ 1:4), by dose number
The proportion of participants achieving ≥ 4-fold increase in strain-specific HAI titer from baseline in all participants regardless of baseline serostatus, by dose number

Secondary Outcome Measures

Safety endpoints include: AEs SAEs and significant new medical conditions for all participants

Full Information

First Posted
May 23, 2005
Last Updated
July 22, 2008
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00111579
Brief Title
Study to Evaluate the Immune Responses of Trivalent Cold-Adapted Influenza Vaccine (CAIV-T) Compared With (TIV)
Official Title
A Prospective, Randomized, Open-Label Study to Evaluate the Immune Responses of Trivalent Cold-Adapted Influenza Vaccine (CAIV-T) Compared With Trivalent Inactivated Vaccine (TIV) in Children 6 to <36 Months of Age
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to describe the level of serum antibody conferred by CAIV-T and TIV against homotypic and heterotypic influenza virus strains.

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
None (Open Label)
Allocation
Randomized
Enrollment
52 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
CAIV-T
Arm Title
2
Arm Type
Other
Arm Description
TIV
Intervention Type
Biological
Intervention Name(s)
CAIV-T
Intervention Description
A total vol. of 0.2 mL will be administered intranasally (approx. 0.1 mL into each nostril)for ea. of two doses.
Intervention Type
Other
Intervention Name(s)
TIV
Intervention Description
A total vol. of 0.25 will be administered intramuscularly for each of two doeses.
Primary Outcome Measure Information:
Title
The following immunogenicity endpoints: The strain-specific HAI seroconversion rates (≥ 4-fold increase) among baseline seronegative participants (HAI titer ≤ 1:4), by dose number
Time Frame
Day 28 post final vaccination
Title
The proportion of participants achieving ≥ 4-fold increase in strain-specific HAI titer from baseline in all participants regardless of baseline serostatus, by dose number
Time Frame
Day 28 post final vaccination
Secondary Outcome Measure Information:
Title
Safety endpoints include: AEs SAEs and significant new medical conditions for all participants
Time Frame
Day 28 post 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: Male or Female Ages 6 to but less than 36 months (reached their 6th month but have not yet reached their 3rd birthday) at the time of randomization Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the participant's parent/legal representative Ability of the parent/legal representative to understand and comply with the requirements of the study Parent/legal representative available by telephone Ability to complete follow-up period of 180 days after final study vaccination, as required by the protocol Exclusion Criteria: History of hypersensitivity to any component of CAIV-T or TIV, including egg or egg products, monosodium glutamate, porcine gelatin or thimerosal History of hypersensitivity to gentamicin Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy Household contact who is immunocompromised (participants should also avoid close contact with immunocompromised individuals for at least 21 days after each study vaccination) History of Guillain-Barre syndrome Medically diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled), by parent/legal representative report or chart review, within the 42 days prior to randomization (i.e., children with recent persistent asthma are excluded); or history of severe persistent asthma, according to the criteria described in the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma - Update on Selected Topics 2002 Acute febrile (not greater than 100.0 degrees F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to either study vaccination Use of aspirin or aspirin-containing products within 30 days prior to randomization, or expected use through 180 days after final study vaccination Receipt of any prior influenza vaccine Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to randomization, or expected use through 180 days after final study vaccination Administration of any live virus vaccine within 30 days prior to randomization, or expected receipt through 30 days after final study vaccination Administration of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization, or expected receipt within 14 days before, or 14 days after, either study vaccination Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 180 days after final study vaccination (use of licensed agents for indications not listed in the package insert is permitted) Receipt of any blood product within 90 days prior to randomization, or expected receipt through 180 days after final study vaccination Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study Any condition that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of the study results
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
Wee Care Pediatrics
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Bear Care Pediatrics
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Alpine Pediatrics
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
Facility Name
Utah Valley Pediatrics
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Families First Pediatrics
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States

12. IPD Sharing Statement

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Study to Evaluate the Immune Responses of Trivalent Cold-Adapted Influenza Vaccine (CAIV-T) Compared With (TIV)

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