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Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00128167
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : September 13, 2021
Sponsor:
Information provided by:
MedImmune LLC

Study Description
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Brief Summary:
The primary objective of this study is to estimate the relative efficacy and assess the safety of CAIV-T compared to TIV.

Condition or disease Intervention/treatment Phase
Influenza Drug: Liquid CAIV-T Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 8500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind Trial to Assess the Safety and Relative Efficacy of CAIV-T Against Inactivated Influenza Vaccine in Children 6-59 Months of Age
Study Start Date : October 2004
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The primary efficacy endpoint of this study is the relative efficacy of CAIV-T
  2. compared to TIV against the incidence of culture-confirmed symptomatic influenza infection caused by community-acquired wild-type strains antigenically similar to those contained in the vaccine, occurring during the
  3. influenza surveillance period and at least 14 days after the last required vaccination

Secondary Outcome Measures :
  1. Culture-confirmed symptomatic influenza infection regardless of antigenic match
  2. Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection antigenically similar to vaccine strains
  3. Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection regardless of antigenic match
  4. Lower respiratory illness (LRI) with culture-confirmed influenza infection antigenically similar to vaccine strains and
  5. Lower respiratory illness (LRI) with culture-confirmed influenza infection regardless of antigenic match

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 6-59 months of age (not yet reached their 5th birthday)
  • Parent or guardian available by telephone
  • Available for illness visits at clinic or at home during the influenza surveillance period
  • Written informed consent (and Health Insurance Portability and Accountability Act [HIPAA] authorization for U.S. Participants) obtained from the participant's parent or legal guardian and
  • Ability of the parent/guardian to understand and comply with the requirements of the protocol

Exclusion Criteria:

  • History of hypersensitivity to any component of CAIV-T or inactivated influenza vaccine, including egg or egg protein
  • History of hypersensitivity to gentamicin
  • Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
  • History of Guillain-Barre syndrome
  • Medically-diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled) within the previous 42 days by parent report or chart review (e.g., children with recent persistent asthma are excluded), or history of severe asthma
  • Acute febrile (>100.0 degrees F or >37.8 degrees C oral or equivalent) illness or acute respiratory illness, including sore throat, within three days prior to enrollment
  • Receipt of an investigational product within 30 days prior to enrollment or expected receipt during this study
  • Use of aspirin or salicylate-containing products 30 days prior to enrollment or expected receipt during this study
  • Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment or expected receipt during this study
  • Receipt of any blood product within 90 days prior to vaccination or expected receipt during this study
  • Administration of any live virus vaccine within 30 days prior to enrollment, or if receipt of another live virus vaccine is expected within 30 days of any study vaccination
  • Administration of any inactivated vaccine within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days of any study vaccination
  • Close contact who is severely immunocompromised (e.g., transplant recipient)
  • Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study and
  • Any condition that, in the opinion of the investigator, might interfere with the interpretation or evaluation of the vaccines.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128167


Locations
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Sponsors and Collaborators
MedImmune LLC
Investigators
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Study Director: Robert Walker, M.D. MedImmune LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00128167    
Other Study ID Numbers: MI-CP111
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: July 2006
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases