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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00111579
First received: May 23, 2005
Last updated: July 22, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: CAIV-T
Other: TIV
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

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 [ Time Frame: Day 28 post final vaccination ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety endpoints include: AEs SAEs and significant new medical conditions for all participants [ Time Frame: Day 28 post vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 52
Study Start Date: May 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
CAIV-T
Biological: CAIV-T
A total vol. of 0.2 mL will be administered intranasally (approx. 0.1 mL into each nostril)for ea. of two doses.
2
TIV
Other: TIV
A total vol. of 0.25 will be administered intramuscularly for each of two doeses.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111579

Locations
United States, Utah
Wee Care Pediatrics
Layton, Utah, United States, 84041
Bear Care Pediatrics
Ogden, Utah, United States, 84405
Alpine Pediatrics
Pleasant Grove, Utah, United States, 84062
Utah Valley Pediatrics
Provo, Utah, United States, 84604
Families First Pediatrics
South Jordan, Utah, United States, 84095
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Robert Walker, MD MedImmune LLC
  More Information

No publications provided

Responsible Party: Chris Ambrose, Dir. Medical Affairs, MedImmune LLC
ClinicalTrials.gov Identifier: NCT00111579     History of Changes
Other Study ID Numbers: MI-CP123
Study First Received: May 23, 2005
Last Updated: July 22, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014