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

Completed · Phase 3

Conditions studied: Influenza

In brief

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

Key facts

Study ID

NCT00128167

Run by

MedImmune LLC

People needed

8500

Starts

2004-10-01

Expected to finish

2005-12-01

Last updated by the study team

2021-09-13

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama — Tuscaloosa, Alabama, United States
• Little Rock Allergy and Asthma Clinical — Little Rock, Arkansas, United States
• Friendly Care Medical Group — Anaheim, California, United States
• Impact Clinical Trials — Beverly Hills, California, United States
• Family Medical Center — Foothill Ranch, California, United States
• Edinger Mecial Group — Fountain Valley, California, United States
• Fresno Childrens Medical Group, Inc. — Fresno, California, United States
• Heathcare Partners Medical Group — Los Angeles, California, United States
• Kaiser Permanente Vaccine Study Center — Oakland, California, United States
• PRA Trials — Rolling Hills Estates, California, United States
• Benchmark Research — San Francisco, California, United States
• Convenience Care — West Covina, California, United States
• Norwich Pediatric Group, PC — Norwich, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Clinical Research Care & Resource Center, Inc — Miami, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• Pediatric Research Center of South Florida — Palm Beach Gardens, Florida, United States
• Emory University School of Medicine, Dept of Pediatrics, Div of Infectious Diseases — Atlanta, Georgia, United States
• Pediatrics and Adolescent Medicine, P.A. — Marietta, Georgia, United States
• Medical Parameters — Martinez, Georgia, United States
• Rush University Medical Center/University Consultatnts in Allergy and Immunology — Chicago, Illinois, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Sneeze, Wheeze, & Itch Associates, LLC — Normal, Illinois, United States
• South Bend Clinic — South Bend, Indiana, United States
• Clinical Research Consultants, Inc — Hoover, Alabama, United States

Full record on ClinicalTrials.gov

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