Clinical trial NCT00128167: Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-08-09
Enrollment: 8500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: The primary efficacy endpoint of this study is the relative efficacy of CAIV-T
measure: 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
measure: influenza surveillance period and at least 14 days after the last required vaccination
Secondary outcomes:
measure: Culture-confirmed symptomatic influenza infection regardless of antigenic match
measure: Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection antigenically similar to vaccine strains
measure: Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection regardless of antigenic match
measure: Lower respiratory illness (LRI) with culture-confirmed influenza infection antigenically similar to vaccine strains and
measure: Lower respiratory illness (LRI) with culture-confirmed influenza infection regardless of antigenic match
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Clinical Research Consultants, Inc
state: Alabama
city: Tuscaloosa
country: United States
facility: University of Alabama
state: Alabama
city: Little Rock
country: United States
facility: Little Rock Allergy and Asthma Clinical
state: Arkansas
city: Anaheim
country: United States
facility: Friendly Care Medical Group
state: California
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: Foothill Ranch
country: United States
facility: Family Medical Center
state: California
city: Fountain Valley
country: United States
facility: Edinger Mecial Group
state: California
city: Fresno
country: United States
facility: Fresno Childrens Medical Group, Inc.
state: California
city: Los Angeles
country: United States
facility: Heathcare Partners Medical Group
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Vaccine Study Center
state: California
city: Rolling Hills Estates
country: United States
facility: PRA Trials
state: California
city: San Francisco
country: United States
facility: Benchmark Research
state: California
city: West Covina
country: United States
facility: Convenience Care
state: California
city: Norwich
country: United States
facility: Norwich Pediatric Group, PC
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Miami
country: United States
facility: Clinical Research Care & Resource Center, Inc
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Palm Beach Gardens
country: United States
facility: Pediatric Research Center of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine, Dept of Pediatrics, Div of Infectious Diseases
state: Georgia
city: Marietta
country: United States
facility: Pediatrics and Adolescent Medicine, P.A.
state: Georgia
city: Martinez
country: United States
facility: Medical Parameters
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center/University Consultatnts in Allergy and Immunology
state: Illinois
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates, LLC
state: Illinois
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Shawnee Mission
country: United States
facility: Heart of America Research Institute
state: Kansas
city: Topeka
country: United States
facility: Heart of America Research Institute-Topeka
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatrics/Adult Research Inc.
state: Kentucky
city: Louisville
country: United States
facility: University Child Health Specialists, PCTU
state: Kentucky
city: Bogalusa
country: United States
facility: Clinical Trials Management, LLC/The Pediatric Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Dolby Providers LLC
state: Louisiana
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Woburn
country: United States
facility: Woburn Pediatric Associates
state: Massachusetts
city: Dearborn
country: United States
facility: Odyssey Research
state: Michigan
city: Detroit
country: United States
facility: Chidren's Hospital of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Center for Vaccine Development
state: Missouri
city: Bozeman
country: United States
facility: Bozeman Urgent Care Center
state: Montana
city: Omaha
country: United States
facility: Creighton/UNMC Pediatric Infectious Disease
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Henderson
country: United States
facility: Henderson Pediatrics
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Summit
country: United States
facility: Summit Pediatric Pulmonary
state: New Jersey
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Barbara Dzierzek/PharmaTrials, Inc.
state: New York
city: Cortland
country: United States
facility: Health Sciences Research Center
state: New York
city: Endwell
country: United States
facility: Endwell Family Physicians
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Nanuet
country: United States
facility: Clarkstown Pediatric Associates
state: New York
city: New York
country: United States
facility: CPMC Research Pharmacy
state: New York
city: Rochester
country: United States
facility: Elmwood Pediatrics
state: New York
city: Rochester
country: United States
facility: University Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: Northeast Pediatrics and Adolescent Medicine
state: New York
city: Boone
country: United States
facility: Boone Pediatric Center
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina Department of Pediatrics
state: North Carolina
city: Laurinburg
country: United States
facility: Purcell Clinic
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Sylva
country: United States
facility: Sylva Pediatrics Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Ford, Simpson, Lively and Rice Pediatrics
state: North Carolina
city: Bismarck
country: United States
facility: Odyssey Research
state: North Dakota
city: Fargo
country: United States
facility: Dakota Clinic/Innovis Health
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel
state: Ohio
city: Huber Heights
country: United States
facility: Ohio Pediatrics
state: Ohio
city: University Heights
country: United States
facility: Shelly Senders and Associates
state: Ohio
city: Oklahoma City
country: United States
facility: Grand Prairie Pediatric and Allergy Clinic
state: Oklahoma
city: Tulsa
country: United States
facility: Hillcrest Medical Group/Utica Park Clinic
state: Oklahoma
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Primary Physicians Research Inc.
state: Pennsylvania
city: Upland
country: United States
facility: Asthma & Allergy Research Associates
state: Pennsylvania
city: Barrington
country: United States
facility: East Bay Pediatrics
state: Rhode Island
city: Cranston
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Watertown
country: United States
facility: Northridge Brown Clinic
state: South Dakota
city: Dyersburg
country: United States
facility: Medsouth Healthcare
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group Pediatrics
state: Tennessee
city: Murfreesboro
country: United States
facility: Murfressboro Medical Clinic
state: Tennessee
city: Nashville
country: United States
facility: Pediatric Clincal Research Office
state: Tennessee
city: Austin
country: United States
facility: Wells Branch Medical Center
state: Texas
city: Conroe
country: United States
facility: Sadler Clinic/Healthsouth Clinical Research
state: Texas
city: Dallas
country: United States
facility: Pediatric Allergy/Immunology Associates, PA
state: Texas
city: Fort Worth
country: United States
facility: Healthfirst Medical Group
state: Texas
city: Houston
country: United States
facility: Med-Pro Research Inc.
state: Texas
city: Killeen
country: United States
facility: Scott and White/Pediatric Clinic
state: Texas
city: Lake Jackson
country: United States
facility: Rd Clinical Research Inc.
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: San Antonio
country: United States
facility: Quality Assurance Research Center
state: Texas
city: Layton
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Murray
country: United States
facility: Cottonwood Pediatrics
state: Utah
city: Ogden
country: United States
facility: Bear Care Pediatrics
state: Utah
city: Pleasant Grove
country: United States
facility: Alpine Pediatrics
state: Utah
city: Provo
country: United States
facility: Utah Valley Pediatrics
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc.
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc.
state: Utah
city: South Jordan
country: United States
facility: Families First Pediatrics
state: Utah
city: West Jordan
country: United States
facility: J. Lewis Research/Southwest Family Medicine
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Charlottesville
country: United States
facility: Respiratory Disease Study Unit
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc
state: Virginia
city: Norfolk
country: United States
facility: Center for Pediatric Research
state: Virginia
city: Richmond
country: United States
facility: VCU Campus Children's Pavilion/Pediatric Clinical Trials Office
state: Virginia
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
city: Huntington
country: United States
facility: Univeristy Pediatrics
state: West Virginia
city: Monroe
country: United States
facility: Monroe Medical Foundation
state: Wisconsin
city: Antwerp
country: Belgium
facility: Sint-Vincentiusziekenhuis Sint-Vincentiusstraat
city: Berchem
country: Belgium
facility: Private Practice
city: Brussel
country: Belgium
facility: UVC Brugmann
city: Brussel
country: Belgium
facility: AZ-VUB Paediatric Clinic
city: Drongen
country: Belgium
facility: Private Practice
city: Leuven
country: Belgium
facility: KUL Dienst Jeugdgezondheidszorg
city: Schoten
country: Belgium
facility: Private Practice
city: Tienen
country: Belgium
facility: Private Practice
city: Wondelgem
country: Belgium
facility: Private Practice
city: Boskovice
country: Czechia
facility: IN Boskovice a. s. Detské oddelení
city: Boskovice
country: Czechia
facility: In Boskovice a.s. Detske oddeleni
city: Lysice
country: Czechia
facility: Privantni praxe praktickenho
city: Lysice
country: Czechia
facility: Privátní praxe praktického lékare pro deti a dorost Lysice
city: Most
country: Czechia
facility: Nemocnice s poliklinikou v Moste
city: Plzen
country: Czechia
facility: STOPED s.r.o.
city: Chai Wan
country: Hong Kong
facility: Department of Pediatrics
city: Hang Hau
country: Hong Kong
facility: Department of Pediatrics/Adolescent Medicine
city: Kowloon
country: Hong Kong
facility: Department of Pediatrics - Paediatrics Unit
city: Lai Chi Kok
country: Hong Kong
facility: Department of Pediatrics/Adolescent Medicine
city: Shatin
country: Hong Kong
facility: Department of Pediactrics
city: Bangor County
country: Ireland
facility: Springhill Surgery
city: Randalsotown
country: Ireland
facility: Randalstown Health Centre
city: Whiteabbey
country: Ireland
facility: Nottinghill Practice, Whiteabbey Health Centre
city: Seoul
country: Korea, Republic of
facility: Department of Pediatrics
city: Seoul
country: Korea, Republic of
facility: Dept. of Pediatrics
city: Seoul
country: Korea, Republic of
facility: Department of Pediatrics
city: Seoul
country: Korea, Republic of
facility: Department of Pediatrics
city: Changhua
country: Taiwan
facility: Department of Pediatrics
city: Taichung
country: Taiwan
facility: Department of Pediatrics
city: Taipei
country: Taiwan
facility: Department of Pediatrics
city: Taipei
country: Taiwan
facility: Department of Pediatrics
city: Taoyuan
country: Taiwan
facility: Department of Pediatrics
city: Barnsely
country: United Kingdom
facility: Ashville Medical Center
state: South Yorks
city: Ayrshire
country: United Kingdom
facility: Townhead Surgery
city: Ayr
country: United Kingdom
facility: Cathcart Street Practice
city: Bolton
country: United Kingdom
facility: Stonehill Medical Centre
city: Bristol
country: United Kingdom
facility: The Orchard Medical Centre
city: Cambs
country: United Kingdom
facility: The Staploe Medical Centre
city: Chesterfield
country: United Kingdom
facility: Avondale Surgery Research
city: Cornwall
country: United Kingdom
facility: Saltash Health Centre
city: Coventry
country: United Kingdom
facility: Woodend Health Centre
city: Coventry
country: United Kingdom
facility: Gabels Medical Centre
city: Coventry
country: United Kingdom
facility: Govind Health Cenre
city: Devon Plymouth
country: United Kingdom
facility: Woolwell Medical Centre
city: East Horley
country: United Kingdom
facility: The Medical Centre
city: Fife
country: United Kingdom
facility: Valleyfield Health Centre
city: Glasgow
country: United Kingdom
facility: Castlemilk Health Centre
city: Glasgow
country: United Kingdom
facility: Kingsway Medical
city: Lancs
country: United Kingdom
facility: Layton Medical Centre
city: Nottingham
country: United Kingdom
facility: Greenwood & Sneinton Family Medical Practice
city: Peterborough
country: United Kingdom
facility: Landsdowne Road Yaxley
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery
city: Wansford
country: United Kingdom
facility: Wansford Surgery
city: Warwick Shire
country: United Kingdom
facility: Sherbourne Medical Centre
Study officials:
affiliation: MedImmune LLC
name: Robert Walker, M.D.
role: STUDY_DIRECTOR
References:
citation: Belshe RB, Edwards KM, Vesikari T, Black SV, Walker RE, Hultquist M, Kemble G, Connor EM; CAIV-T Comparative Efficacy Study Group. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med. 2007 Feb 15;356(7):685-96. doi: 10.1056/NEJMoa065368.