Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age
- Conditions
- Influenza
- Registration Number
- NCT00128167
- Lead Sponsor
- MedImmune LLC
- Brief Summary
The primary objective of this study is to estimate the relative efficacy and assess the safety of CAIV-T compared to TIV.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8500
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method influenza surveillance period and at least 14 days after the last required vaccination 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
- Secondary Outcome Measures
Name Time Method Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection regardless of antigenic match 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 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
Trial Locations
- Locations (146)
Pediatrics and Adolescent Medicine, P.A.
🇺🇸Marietta, Georgia, United States
Kentucky Pediatrics/Adult Research Inc.
🇺🇸Bardstown, Kentucky, United States
Pediatric Allergy/Immunology Associates, PA
🇺🇸Dallas, Texas, United States
J. Lewis Research/Southwest Family Medicine
🇺🇸West Jordan, Utah, United States
Clinical Research Care & Resource Center, Inc
🇺🇸Miami, Florida, United States
Emory University School of Medicine, Dept of Pediatrics, Div of Infectious Diseases
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center/University Consultatnts in Allergy and Immunology
🇺🇸Chicago, Illinois, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Pediatric Associates of Mt. Carmel
🇺🇸Cincinnati, Ohio, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Primary Physicians Research Inc.
🇺🇸Pittsburgh, Pennsylvania, United States
Med-Pro Research Inc.
🇺🇸Houston, Texas, United States
Barbara Dzierzek/PharmaTrials, Inc.
🇺🇸Brooklyn, New York, United States
Impact Clinical Trials
🇺🇸Beverly Hills, California, United States
Purcell Clinic
🇺🇸Laurinburg, North Carolina, United States
Endwell Family Physicians
🇺🇸Endwell, New York, United States
Healthfirst Medical Group
🇺🇸Fort Worth, Texas, United States
Asthma & Allergy Research Associates
🇺🇸Upland, Pennsylvania, United States
Rd Clinical Research Inc.
🇺🇸Lake Jackson, Texas, United States
Center for Pediatric Research
🇺🇸Norfolk, Virginia, United States
Central Texas Health Research
🇺🇸New Braunfels, Texas, United States
Holston Medical Group Pediatrics
🇺🇸Kingsport, Tennessee, United States
Monroe Medical Foundation
🇺🇸Monroe, Wisconsin, United States
Springhill Surgery
🇮🇪Bangor County, Ireland
Wee Care Pediatrics
🇺🇸Layton, Utah, United States
Sint-Vincentiusziekenhuis Sint-Vincentiusstraat
🇧🇪Antwerp, Belgium
Private Practice
🇧🇪Wondelgem, Belgium
UVC Brugmann
🇧🇪Brussel, Belgium
Department of Pediatrics
🇨🇳Taoyuan, Taiwan
Randalstown Health Centre
🇮🇪Randalsotown, Ireland
AZ-VUB Paediatric Clinic
🇧🇪Brussel, Belgium
J. Lewis Research Inc.
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc.
🇺🇸Salt Lake City, Utah, United States
Grand Prairie Pediatric and Allergy Clinic
🇺🇸Oklahoma City, Oklahoma, United States
Center for Vaccine Development
🇺🇸Saint Louis, Missouri, United States
CPMC Research Pharmacy
🇺🇸New York, New York, United States
Convenience Care
🇺🇸West Covina, California, United States
Heathcare Partners Medical Group
🇺🇸Los Angeles, California, United States
Edinger Mecial Group
🇺🇸Fountain Valley, California, United States
PRA Trials
🇺🇸Rolling Hills Estates, California, United States
University of Alabama
🇺🇸Tuscaloosa, Alabama, United States
Benchmark Research
🇺🇸San Angelo, Texas, United States
Heart of America Research Institute-Topeka
🇺🇸Topeka, Kansas, United States
Odyssey Research
🇺🇸Bismarck, North Dakota, United States
Medical Parameters
🇺🇸Martinez, Georgia, United States
Heart of America Research Institute
🇺🇸Shawnee Mission, Kansas, United States
Health Sciences Research Center
🇺🇸Cortland, New York, United States
Sneeze, Wheeze, & Itch Associates, LLC
🇺🇸Normal, Illinois, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
Dakota Clinic/Innovis Health
🇺🇸Fargo, North Dakota, United States
Elmwood Pediatrics
🇺🇸Rochester, New York, United States
University Rochester Medical Center
🇺🇸Rochester, New York, United States
Respiratory Disease Study Unit
🇺🇸Charlottesville, Virginia, United States
PI-Coor Clinical Research, LLC
🇺🇸Burke, Virginia, United States
Kingsway Medical
🇬🇧Glasgow, United Kingdom
Wansford Surgery
🇬🇧Wansford, United Kingdom
Advanced Pediatrics
🇺🇸Vienna, Virginia, United States
Quality Assurance Research Center
🇺🇸San Antonio, Texas, United States
Northeast Pediatrics and Adolescent Medicine
🇺🇸Syracuse, New York, United States
Health Research of Hampton Roads, Inc
🇺🇸Newport News, Virginia, United States
Privantni praxe praktickenho
🇨🇿Lysice, Czechia
Privátnà praxe praktického lékare pro deti a dorost Lysice
🇨🇿Lysice, Czechia
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Ohio Pediatrics
🇺🇸Huber Heights, Ohio, United States
Univeristy Pediatrics
🇺🇸Huntington, West Virginia, United States
Stonehill Medical Centre
🇬🇧Bolton, United Kingdom
Avondale Surgery Research
🇬🇧Chesterfield, United Kingdom
Woolwell Medical Centre
🇬🇧Devon Plymouth, United Kingdom
The Medical Centre
🇬🇧East Horley, United Kingdom
Valleyfield Health Centre
🇬🇧Fife, United Kingdom
Layton Medical Centre
🇬🇧Lancs, United Kingdom
In Boskovice a.s. Detske oddeleni
🇨🇿Boskovice, Czechia
Landsdowne Road Yaxley
🇬🇧Peterborough, United Kingdom
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
East Bay Pediatrics
🇺🇸Barrington, Rhode Island, United States
Shelly Senders and Associates
🇺🇸University Heights, Ohio, United States
Ashville Medical Center
🇬🇧Barnsely, South Yorks, United Kingdom
STOPED s.r.o.
🇨🇿Plzen, Czechia
Nemocnice s poliklinikou v Moste
🇨🇿Most, Czechia
Cathcart Street Practice
🇬🇧Ayr, United Kingdom
Gabels Medical Centre
🇬🇧Coventry, United Kingdom
Northridge Brown Clinic
🇺🇸Watertown, South Dakota, United States
Sadler Clinic/Healthsouth Clinical Research
🇺🇸Conroe, Texas, United States
Scott and White/Pediatric Clinic
🇺🇸Killeen, Texas, United States
Saltash Health Centre
🇬🇧Cornwall, United Kingdom
Castlemilk Health Centre
🇬🇧Glasgow, United Kingdom
Knowle House Surgery
🇬🇧Plymouth, United Kingdom
Clinical Research Consultants, Inc
🇺🇸Hoover, Alabama, United States
Family Medical Center
🇺🇸Foothill Ranch, California, United States
Friendly Care Medical Group
🇺🇸Anaheim, California, United States
Fresno Childrens Medical Group, Inc.
🇺🇸Fresno, California, United States
Kaiser Permanente Vaccine Study Center
🇺🇸Oakland, California, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Chidren's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
United Medical Associates
🇺🇸Binghamton, New York, United States
Boone Pediatric Center
🇺🇸Boone, North Carolina, United States
Clarkstown Pediatric Associates
🇺🇸Nanuet, New York, United States
Sylva Pediatrics Associates
🇺🇸Sylva, North Carolina, United States
Hillcrest Medical Group/Utica Park Clinic
🇺🇸Tulsa, Oklahoma, United States
Medsouth Healthcare
🇺🇸Dyersburg, Tennessee, United States
Omega Medical Research
🇺🇸Cranston, Rhode Island, United States
Murfressboro Medical Clinic
🇺🇸Murfreesboro, Tennessee, United States
Cottonwood Pediatrics
🇺🇸Murray, Utah, United States
Bear Care Pediatrics
🇺🇸Ogden, Utah, United States
KUL Dienst Jeugdgezondheidszorg
🇧🇪Leuven, Belgium
IN Boskovice a. s. Detské oddelenÃ
🇨🇿Boskovice, Czechia
Townhead Surgery
🇬🇧Ayrshire, United Kingdom
The Orchard Medical Centre
🇬🇧Bristol, United Kingdom
The Staploe Medical Centre
🇬🇧Cambs, United Kingdom
Govind Health Cenre
🇬🇧Coventry, United Kingdom
Woodend Health Centre
🇬🇧Coventry, United Kingdom
Greenwood & Sneinton Family Medical Practice
🇬🇧Nottingham, United Kingdom
Sherbourne Medical Centre
🇬🇧Warwick Shire, United Kingdom
Dept. of Pediatrics
🇰🇷Seoul, Korea, Republic of
Summit Pediatric Pulmonary
🇺🇸Summit, New Jersey, United States
Clinical Trials Management, LLC/The Pediatric Clinic
🇺🇸Bogalusa, Louisiana, United States
Little Rock Allergy and Asthma Clinical
🇺🇸Little Rock, Arkansas, United States
Pediatric Research Center of South Florida
🇺🇸Palm Beach Gardens, Florida, United States
Woburn Pediatric Associates
🇺🇸Woburn, Massachusetts, United States
Bozeman Urgent Care Center
🇺🇸Bozeman, Montana, United States
Henderson Pediatrics
🇺🇸Henderson, Nevada, United States
Creighton/UNMC Pediatric Infectious Disease
🇺🇸Omaha, Nebraska, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Meridian Clinical Research, LLC
🇺🇸Omaha, Nebraska, United States
Dolby Providers LLC
🇺🇸New Orleans, Louisiana, United States
Pediatric Clincal Research Office
🇺🇸Nashville, Tennessee, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Nottinghill Practice, Whiteabbey Health Centre
🇮🇪Whiteabbey, Ireland
Alpine Pediatrics
🇺🇸Pleasant Grove, Utah, United States
Families First Pediatrics
🇺🇸South Jordan, Utah, United States
University Child Health Specialists, PCTU
🇺🇸Louisville, Kentucky, United States
University of North Carolina Department of Pediatrics
🇺🇸Chapel Hill, North Carolina, United States
Ford, Simpson, Lively and Rice Pediatrics
🇺🇸Winston-Salem, North Carolina, United States
Wells Branch Medical Center
🇺🇸Austin, Texas, United States
VCU Campus Children's Pavilion/Pediatric Clinical Trials Office
🇺🇸Richmond, Virginia, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Utah Valley Pediatrics
🇺🇸Provo, Utah, United States
Norwich Pediatric Group, PC
🇺🇸Norwich, Connecticut, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Department of Pediatrics - Paediatrics Unit
ðŸ‡ðŸ‡°Kowloon, Hong Kong
Department of Pediactrics
ðŸ‡ðŸ‡°Shatin, Hong Kong
Department of Pediatrics/Adolescent Medicine
ðŸ‡ðŸ‡°Lai Chi Kok, Hong Kong