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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00128167
First received: August 5, 2005
Last updated: July 5, 2006
Last verified: July 2006
  Purpose

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


Condition Intervention Phase
Influenza
Drug: Liquid CAIV-T
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • The primary efficacy endpoint of this study is the relative efficacy of CAIV-T
  • 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
  • influenza surveillance period and at least 14 days after the last required vaccination

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

Estimated Enrollment: 8500
Study Start Date: October 2004
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128167

  Show 161 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Robert Walker, M.D. MedImmune LLC
  More Information

No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00128167     History of Changes
Other Study ID Numbers: MI-CP111
Study First Received: August 5, 2005
Last Updated: July 5, 2006
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 August 27, 2014