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NCT00128167 Clinical Trial

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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00128167
Other study ID # MI-CP111
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2004
Est. completion date December 2005

Study information
Verified date July 2006
Source MedImmune LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 8500
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 59 Months
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Liquid CAIV-T

Locations
Country Name City State
Belgium Sint-Vincentiusziekenhuis Sint-Vincentiusstraat Antwerp
Belgium Private Practice Berchem
Belgium AZ-VUB Paediatric Clinic Brussel
Belgium UVC Brugmann Brussel
Belgium Private Practice Drongen
Belgium KUL Dienst Jeugdgezondheidszorg Leuven
Belgium Private Practice Schoten
Belgium Private Practice Tienen
Belgium Private Practice Wondelgem
Czechia IN Boskovice a. s. Detské oddelení Boskovice
Czechia In Boskovice a.s. Detske oddeleni Boskovice
Czechia Privantni praxe praktickenho Lysice
Czechia Privátní praxe praktického lékare pro deti a dorost Lysice Lysice
Czechia Nemocnice s poliklinikou v Moste Most
Czechia STOPED s.r.o. Plzen
Hong Kong Department of Pediatrics Chai Wan
Hong Kong Department of Pediatrics/Adolescent Medicine Hang Hau
Hong Kong Department of Pediatrics - Paediatrics Unit Kowloon
Hong Kong Department of Pediatrics/Adolescent Medicine Lai Chi Kok
Hong Kong Department of Pediactrics Shatin
Ireland Springhill Surgery Bangor County
Ireland Randalstown Health Centre Randalsotown
Ireland Nottinghill Practice, Whiteabbey Health Centre Whiteabbey
Korea, Republic of Department of Pediatrics Seoul
Korea, Republic of Department of Pediatrics Seoul
Korea, Republic of Department of Pediatrics Seoul
Korea, Republic of Dept. of Pediatrics Seoul
Taiwan Department of Pediatrics Changhua
Taiwan Department of Pediatrics Taichung
Taiwan Department of Pediatrics Taipei
Taiwan Department of Pediatrics Taipei
Taiwan Department of Pediatrics Taoyuan
United Kingdom Cathcart Street Practice Ayr
United Kingdom Townhead Surgery Ayrshire
United Kingdom Ashville Medical Center Barnsely South Yorks
United Kingdom Stonehill Medical Centre Bolton
United Kingdom The Orchard Medical Centre Bristol
United Kingdom The Staploe Medical Centre Cambs
United Kingdom Avondale Surgery Research Chesterfield
United Kingdom Saltash Health Centre Cornwall
United Kingdom Gabels Medical Centre Coventry
United Kingdom Govind Health Cenre Coventry
United Kingdom Woodend Health Centre Coventry
United Kingdom Woolwell Medical Centre Devon Plymouth
United Kingdom The Medical Centre East Horley
United Kingdom Valleyfield Health Centre Fife
United Kingdom Castlemilk Health Centre Glasgow
United Kingdom Kingsway Medical Glasgow
United Kingdom Layton Medical Centre Lancs
United Kingdom Greenwood & Sneinton Family Medical Practice Nottingham
United Kingdom Landsdowne Road Yaxley Peterborough
United Kingdom Knowle House Surgery Plymouth
United Kingdom Wansford Surgery Wansford
United Kingdom Sherbourne Medical Centre Warwick Shire
United States Friendly Care Medical Group Anaheim California
United States Emory University School of Medicine, Dept of Pediatrics, Div of Infectious Diseases Atlanta Georgia
United States Wells Branch Medical Center Austin Texas
United States Kentucky Pediatrics/Adult Research Inc. Bardstown Kentucky
United States East Bay Pediatrics Barrington Rhode Island
United States Impact Clinical Trials Beverly Hills California
United States United Medical Associates Binghamton New York
United States Odyssey Research Bismarck North Dakota
United States Clinical Trials Management, LLC/The Pediatric Clinic Bogalusa Louisiana
United States Boone Pediatric Center Boone North Carolina
United States Boston University Medical Center Boston Massachusetts
United States Bozeman Urgent Care Center Bozeman Montana
United States Jacobi Medical Center Bronx New York
United States Montefiore Medical Center Bronx New York
United States Barbara Dzierzek/PharmaTrials, Inc. Brooklyn New York
United States PI-Coor Clinical Research, LLC Burke Virginia
United States University of North Carolina Department of Pediatrics Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Respiratory Disease Study Unit Charlottesville Virginia
United States Children's Memorial Hospital Chicago Illinois
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 Sadler Clinic/Healthsouth Clinical Research Conroe Texas
United States Health Sciences Research Center Cortland New York
United States Omega Medical Research Cranston Rhode Island
United States Pediatric Allergy/Immunology Associates, PA Dallas Texas
United States Odyssey Research Dearborn Michigan
United States Chidren's Hospital of Michigan Detroit Michigan
United States Medsouth Healthcare Dyersburg Tennessee
United States Endwell Family Physicians Endwell New York
United States Dakota Clinic/Innovis Health Fargo North Dakota
United States Family Medical Center Foothill Ranch California
United States Healthfirst Medical Group Fort Worth Texas
United States Edinger Mecial Group Fountain Valley California
United States Fresno Childrens Medical Group, Inc. Fresno California
United States Henderson Pediatrics Henderson Nevada
United States Clinical Research Consultants, Inc Hoover Alabama
United States Med-Pro Research Inc. Houston Texas
United States Ohio Pediatrics Huber Heights Ohio
United States Univeristy Pediatrics Huntington West Virginia
United States Scott and White/Pediatric Clinic Killeen Texas
United States Holston Medical Group Pediatrics Kingsport Tennessee
United States Rd Clinical Research Inc. Lake Jackson Texas
United States Clinical Research Center of Nevada Las Vegas Nevada
United States Purcell Clinic Laurinburg North Carolina
United States Wee Care Pediatrics Layton Utah
United States Little Rock Allergy and Asthma Clinical Little Rock Arkansas
United States Heathcare Partners Medical Group Los Angeles California
United States University Child Health Specialists, PCTU Louisville Kentucky
United States Pediatrics and Adolescent Medicine, P.A. Marietta Georgia
United States Medical Parameters Martinez Georgia
United States Clinical Research Care & Resource Center, Inc Miami Florida
United States Winthrop University Hospital Mineola New York
United States Monroe Medical Foundation Monroe Wisconsin
United States Murfressboro Medical Clinic Murfreesboro Tennessee
United States Cottonwood Pediatrics Murray Utah
United States Clarkstown Pediatric Associates Nanuet New York
United States Pediatric Clincal Research Office Nashville Tennessee
United States Central Texas Health Research New Braunfels Texas
United States Dolby Providers LLC New Orleans Louisiana
United States Suncoast Clinical Research New Port Richey Florida
United States CPMC Research Pharmacy New York New York
United States Health Research of Hampton Roads, Inc Newport News Virginia
United States Center for Pediatric Research Norfolk Virginia
United States Sneeze, Wheeze, & Itch Associates, LLC Normal Illinois
United States Norwich Pediatric Group, PC Norwich Connecticut
United States Kaiser Permanente Vaccine Study Center Oakland California
United States Bear Care Pediatrics Ogden Utah
United States Grand Prairie Pediatric and Allergy Clinic Oklahoma City Oklahoma
United States Creighton/UNMC Pediatric Infectious Disease Omaha Nebraska
United States Meridian Clinical Research, LLC Omaha Nebraska
United States Pediatric Research Center of South Florida Palm Beach Gardens Florida
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
United States Primary Physicians Research Inc. Pittsburgh Pennsylvania
United States Alpine Pediatrics Pleasant Grove Utah
United States Utah Valley Pediatrics Provo Utah
United States North Carolina Clinical Research Raleigh North Carolina
United States VCU Campus Children's Pavilion/Pediatric Clinical Trials Office Richmond Virginia
United States Elmwood Pediatrics Rochester New York
United States University Rochester Medical Center Rochester New York
United States PRA Trials Rolling Hills Estates California
United States Center for Vaccine Development Saint Louis Missouri
United States J. Lewis Research Inc. Salt Lake City Utah
United States J. Lewis Research, Inc. Salt Lake City Utah
United States Benchmark Research San Angelo Texas
United States Quality Assurance Research Center San Antonio Texas
United States Benchmark Research San Francisco California
United States Heart of America Research Institute Shawnee Mission Kansas
United States South Bend Clinic South Bend Indiana
United States Families First Pediatrics South Jordan Utah
United States Summit Pediatric Pulmonary Summit New Jersey
United States Sylva Pediatrics Associates Sylva North Carolina
United States Northeast Pediatrics and Adolescent Medicine Syracuse New York
United States Heart of America Research Institute-Topeka Topeka Kansas
United States Hillcrest Medical Group/Utica Park Clinic Tulsa Oklahoma
United States University of Alabama Tuscaloosa Alabama
United States Shelly Senders and Associates University Heights Ohio
United States Asthma & Allergy Research Associates Upland Pennsylvania
United States Advanced Pediatrics Vienna Virginia
United States Georgetown University Medical Center Washington District of Columbia
United States Northridge Brown Clinic Watertown South Dakota
United States Convenience Care West Covina California
United States J. Lewis Research/Southwest Family Medicine West Jordan Utah
United States Ford, Simpson, Lively and Rice Pediatrics Winston-Salem North Carolina
United States Woburn Pediatric Associates Woburn Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Hong Kong,  Ireland,  Korea, Republic of,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary efficacy endpoint of this study is the relative efficacy of CAIV-T
Primary 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
Primary influenza surveillance period and at least 14 days after the last required vaccination
Secondary Culture-confirmed symptomatic influenza infection regardless of antigenic match
Secondary Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection antigenically similar to vaccine strains
Secondary Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection regardless of antigenic match
Secondary Lower respiratory illness (LRI) with culture-confirmed influenza infection antigenically similar to vaccine strains and
Secondary Lower respiratory illness (LRI) with culture-confirmed influenza infection regardless of antigenic match
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