Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age
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
1 other identifier
interventional
8,500
8 countries
161
Brief Summary
The primary objective of this study is to estimate the relative efficacy and assess the safety of CAIV-T compared to TIV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2004
Shorter than P25 for phase_3
161 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 5, 2005
CompletedFirst Posted
Study publicly available on registry
August 9, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedSeptember 13, 2021
July 1, 2006
August 5, 2005
September 10, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
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
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (161)
Clinical Research Consultants, Inc
Hoover, Alabama, 35216, United States
University of Alabama
Tuscaloosa, Alabama, 35401, United States
Little Rock Allergy and Asthma Clinical
Little Rock, Arkansas, 72205, United States
Friendly Care Medical Group
Anaheim, California, 92805, United States
Impact Clinical Trials
Beverly Hills, California, 90211, United States
Family Medical Center
Foothill Ranch, California, 92610, United States
Edinger Mecial Group
Fountain Valley, California, 92708-7504, United States
Fresno Childrens Medical Group, Inc.
Fresno, California, 93720, United States
Heathcare Partners Medical Group
Los Angeles, California, 90015, United States
Kaiser Permanente Vaccine Study Center
Oakland, California, 94612, United States
PRA Trials
Rolling Hills Estates, California, 90274, United States
Benchmark Research
San Francisco, California, 94102, United States
Convenience Care
West Covina, California, 91790, United States
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057, United States
Clinical Research Care & Resource Center, Inc
Miami, Florida, 33156, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Pediatric Research Center of South Florida
Palm Beach Gardens, Florida, 33410, United States
Emory University School of Medicine, Dept of Pediatrics, Div of Infectious Diseases
Atlanta, Georgia, 30322, United States
Pediatrics and Adolescent Medicine, P.A.
Marietta, Georgia, 30062, United States
Medical Parameters
Martinez, Georgia, 30907, United States
Rush University Medical Center/University Consultatnts in Allergy and Immunology
Chicago, Illinois, 60612, United States
Children's Memorial Hospital
Chicago, Illinois, 60641, United States
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, 61761, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Heart of America Research Institute
Shawnee Mission, Kansas, 66216, United States
Heart of America Research Institute-Topeka
Topeka, Kansas, 66614, United States
Kentucky Pediatrics/Adult Research Inc.
Bardstown, Kentucky, 40004, United States
University Child Health Specialists, PCTU
Louisville, Kentucky, 40202, United States
Clinical Trials Management, LLC/The Pediatric Clinic
Bogalusa, Louisiana, 70427, United States
Dolby Providers LLC
New Orleans, Louisiana, 70128, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Woburn Pediatric Associates
Woburn, Massachusetts, 01801, United States
Odyssey Research
Dearborn, Michigan, 48126, United States
Chidren's Hospital of Michigan
Detroit, Michigan, 48201, United States
Center for Vaccine Development
St Louis, Missouri, 63110, United States
Bozeman Urgent Care Center
Bozeman, Montana, 59715, United States
Creighton/UNMC Pediatric Infectious Disease
Omaha, Nebraska, 68131, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
Henderson Pediatrics
Henderson, Nevada, 89015, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Summit Pediatric Pulmonary
Summit, New Jersey, 07901, United States
United Medical Associates
Binghamton, New York, 13901, United States
Barbara Dzierzek/PharmaTrials, Inc.
Brooklyn, New York, 11222, United States
Health Sciences Research Center
Cortland, New York, 13045, United States
Endwell Family Physicians
Endwell, New York, 13760, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Clarkstown Pediatric Associates
Nanuet, New York, 10954, United States
CPMC Research Pharmacy
New York, New York, 10032, United States
Elmwood Pediatrics
Rochester, New York, 14620, United States
University Rochester Medical Center
Rochester, New York, 14642, United States
Northeast Pediatrics and Adolescent Medicine
Syracuse, New York, 13210, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Boone Pediatric Center
Boone, North Carolina, 28607, United States
University of North Carolina Department of Pediatrics
Chapel Hill, North Carolina, 79599, United States
Purcell Clinic
Laurinburg, North Carolina, 28352, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Sylva Pediatrics Associates
Sylva, North Carolina, 28779, United States
Ford, Simpson, Lively and Rice Pediatrics
Winston-Salem, North Carolina, 27103, United States
Odyssey Research
Bismarck, North Dakota, 58501, United States
Dakota Clinic/Innovis Health
Fargo, North Dakota, 58104, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Pediatric Associates of Mt. Carmel
Cincinnati, Ohio, 45245, United States
Ohio Pediatrics
Huber Heights, Ohio, 45424, United States
Shelly Senders and Associates
University Heights, Ohio, 44118, United States
Grand Prairie Pediatric and Allergy Clinic
Oklahoma City, Oklahoma, 73132, United States
Hillcrest Medical Group/Utica Park Clinic
Tulsa, Oklahoma, 74104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15123, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Primary Physicians Research Inc.
Pittsburgh, Pennsylvania, 15241-3100, United States
Asthma & Allergy Research Associates
Upland, Pennsylvania, 19013, United States
East Bay Pediatrics
Barrington, Rhode Island, 02806, United States
Omega Medical Research
Cranston, Rhode Island, 02920, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Northridge Brown Clinic
Watertown, South Dakota, 57201, United States
Medsouth Healthcare
Dyersburg, Tennessee, 38024, United States
Holston Medical Group Pediatrics
Kingsport, Tennessee, 37660, United States
Murfressboro Medical Clinic
Murfreesboro, Tennessee, 37130, United States
Pediatric Clincal Research Office
Nashville, Tennessee, 37232-2573, United States
Wells Branch Medical Center
Austin, Texas, 78728, United States
Sadler Clinic/Healthsouth Clinical Research
Conroe, Texas, 77304, United States
Pediatric Allergy/Immunology Associates, PA
Dallas, Texas, 75230, United States
Healthfirst Medical Group
Fort Worth, Texas, 76135, United States
Med-Pro Research Inc.
Houston, Texas, 77004, United States
Scott and White/Pediatric Clinic
Killeen, Texas, 76451, United States
Rd Clinical Research Inc.
Lake Jackson, Texas, 77566, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Benchmark Research
San Angelo, Texas, 76904, United States
Quality Assurance Research Center
San Antonio, Texas, 78207, United States
Wee Care Pediatrics
Layton, Utah, 84041, United States
Cottonwood Pediatrics
Murray, Utah, 84107, United States
Bear Care Pediatrics
Ogden, Utah, 84450, United States
Alpine Pediatrics
Pleasant Grove, Utah, 84062, United States
Utah Valley Pediatrics
Provo, Utah, 84604, United States
J. Lewis Research Inc.
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc.
Salt Lake City, Utah, 84121, United States
Families First Pediatrics
South Jordan, Utah, 84095, United States
J. Lewis Research/Southwest Family Medicine
West Jordan, Utah, 84084, United States
PI-Coor Clinical Research, LLC
Burke, Virginia, 22015, United States
Respiratory Disease Study Unit
Charlottesville, Virginia, 22901, United States
Health Research of Hampton Roads, Inc
Newport News, Virginia, 23606, United States
Center for Pediatric Research
Norfolk, Virginia, 23510, United States
VCU Campus Children's Pavilion/Pediatric Clinical Trials Office
Richmond, Virginia, 23219, United States
Advanced Pediatrics
Vienna, Virginia, 22180-4224, United States
Univeristy Pediatrics
Huntington, West Virginia, 25701, United States
Monroe Medical Foundation
Monroe, Wisconsin, 53566, United States
Sint-Vincentiusziekenhuis Sint-Vincentiusstraat
Antwerp, 2018, Belgium
Private Practice
Berchem, 2600, Belgium
UVC Brugmann
Brussels, 1030, Belgium
AZ-VUB Paediatric Clinic
Brussels, 1090, Belgium
Private Practice
Drongen, 9031, Belgium
KUL Dienst Jeugdgezondheidszorg
Leuven, 3000, Belgium
Private Practice
Schoten, 2900, Belgium
Private Practice
Tienen, 3300, Belgium
Private Practice
Wondelgem, 9032, Belgium
IN Boskovice a. s. Detské oddelení
Boskovice, 680 21, Czechia
In Boskovice a.s. Detske oddeleni
Boskovice, 680 21, Czechia
Privantni praxe praktickenho
Lysice, 679 71, Czechia
Privátní praxe praktického lékare pro deti a dorost Lysice
Lysice, 679 71, Czechia
Nemocnice s poliklinikou v Moste
Most, 434 64, Czechia
STOPED s.r.o.
Pilsen, 301 66, Czechia
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, Hong Kong
Springhill Surgery
Bangor County, BT 19 1PP, Ireland
Randalstown Health Centre
Randalsotown, BT413AE, Ireland
Nottinghill Practice, Whiteabbey Health Centre
Whiteabbey, BT37 9QN, Ireland
Department of Pediatrics
Seoul, 120-752, South Korea
Dept. of Pediatrics
Seoul, 130-702, South Korea
Department of Pediatrics
Seoul, 135-230, South Korea
Department of Pediatrics
Seoul, 152-703, South Korea
Department of Pediatrics
Changhua, 500, Taiwan
Department of Pediatrics
Taichung, 403, Taiwan
Department of Pediatrics
Taipei, 100, Taiwan
Department of Pediatrics
Taipei, 104, Taiwan
Department of Pediatrics
Taoyuan District, 333, Taiwan
Ashville Medical Center
Barnsely, South Yorks, S703RJ, United Kingdom
Cathcart Street Practice
Ayr, KA71BJ, United Kingdom
Townhead Surgery
Ayrshire, KA12 0AY, United Kingdom
Stonehill Medical Centre
Bolton, BL49Q2, United Kingdom
The Orchard Medical Centre
Bristol, BS15 2NJ, United Kingdom
The Staploe Medical Centre
Cambs, CB7 5JD, United Kingdom
Avondale Surgery Research
Chesterfield, S404TF, United Kingdom
Saltash Health Centre
Cornwall, PL12 4BU, United Kingdom
Woodend Health Centre
Coventry, CV2 1XA, United Kingdom
Gabels Medical Centre
Coventry, CV6 4DD, United Kingdom
Govind Health Cenre
Coventry, Cv66 4DD, United Kingdom
Woolwell Medical Centre
Devon Plymouth, United Kingdom
The Medical Centre
East Horley, KT246QT, United Kingdom
Valleyfield Health Centre
Fife, KY128SJ, United Kingdom
Castlemilk Health Centre
Glasgow, G459AW, United Kingdom
Kingsway Medical
Glasgow, United Kingdom
Layton Medical Centre
Lancs, FY37EN, United Kingdom
Greenwood & Sneinton Family Medical Practice
Nottingham, NG37DQ, United Kingdom
Landsdowne Road Yaxley
Peterborough, PE7 3JL, United Kingdom
Knowle House Surgery
Plymouth, PL5 3JD, United Kingdom
Wansford Surgery
Wansford, PE86LP, United Kingdom
Sherbourne Medical Centre
Warwick Shire, CV324RA, United Kingdom
Related Publications (1)
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.
PMID: 17301299DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Walker, M.D.
MedImmune LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 5, 2005
First Posted
August 9, 2005
Study Start
October 1, 2004
Study Completion
December 1, 2005
Last Updated
September 13, 2021
Record last verified: 2006-07