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The primary objective of this study is to estimate the relative efficacy and assess the safety of CAIV-T compared to TIV.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid CAIV-T | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Walker, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Consultants, Inc | Hoover | Alabama | 35216 | United States | ||
| University of Alabama |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17301299 | Derived | 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. |
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| 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 |
| 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 | 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 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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