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

Condition	Intervention	Phase
Influenza	Drug: Liquid CAIV-T	Phase III

Ages Eligible for Study:  6 Months   -   59 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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 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 immosuppressive therapy
• History of Guillain-Barre syndrome
• Medically-diagnosed wheezing, bronchodilator use, or steriod 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
• Acture 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
• Administraiton 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.

Alabama
      Clinical Research Consultants, Inc, Hoover,  Alabama,  35216,  United States
      University of Alabama, Tuscaloosa,  Alabama,  35401,  United States
Arkansas
      Little Rock Allergy and Asthma Clinical, Little Rock,  Arkansas,  72205,  United States
California
      Impact Clinical Trials, Beverly Hills,  California,  90211,  United States
      Heathcare Partners Medical Group, Los Angeles,  California,  90015,  United States
      Fresno Childrens Medical Group, Inc., Fresno,  California,  93720,  United States
      Family Medical Center, Foothill Ranch,  California,  92610,  United States
      Friendly Care Medical Group, Anaheim,  California,  92805,  United States
      PRA Trials, Rolling Hills Estates,  California,  90274,  United States
      Edinger Mecial Group, Fountain Valley,  California,  92708-7504,  United States
      Convenience Care, West Covina,  California,  91790,  United States
      Kaiser Permanente Vaccine Study Center, Oakland,  California,  94612,  United States
      Benchmark Research, San Francisco,  California,  94102,  United States
Connecticut
      Norwich Pediatric Group, PC, Norwich,  Connecticut,  06360,  United States
District of Columbia
      Georgetown University Medical Center, Washington,  District of Columbia,  20057,  United States
Florida
      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
Georgia
      Pediatrics and Adolescent Medicine, P.A., Marietta,  Georgia,  30062,  United States
      Emory University School of Medicine, Dept of Pediatrics, Div of Infectious Diseases, Atlanta,  Georgia,  30322,  United States
      Medical Parameters, Martinez,  Georgia,  30907,  United States
Illinois
      Rush University Medical Center/University Consultatnts in Allergy and Immunology, Chicago,  Illinois,  60612,  United States
      Sneeze, Wheeze, & Itch Associates, LLC, Normal,  Illinois,  61761,  United States
      Children''''s Memorial Hospital, Chicago,  Illinois,  60641,  United States
Indiana
      South Bend Clinic, South Bend,  Indiana,  46617,  United States
Kansas
      Heart of America Research Institute, Shawnee,  Kansas,  66216,  United States
      Heart of America Research Institute-Topeka, Topeka,  Kansas,  66614,  United States
Kentucky
      Kentucky Pediatrics/Adult Research Inc., Bardstown,  Kentucky,  40004,  United States
      University Child Health Specialists, PCTU, Louisville,  Kentucky,  40202,  United States
Louisiana
      Dolby Providers LLC, New Orleans,  Louisiana,  70128,  United States
      Clinical Trials Management, LLC/The Pediatric Clinic, Bogalusa,  Louisiana,  70427,  United States
Massachusetts
      Woburn Pediatric Associates, Woburn,  Massachusetts,  01801,  United States
      Boston University Medical Center, Boston,  Massachusetts,  02118,  United States
Michigan
      Chidren''''s Hospital of Michigan, Detroit,  Michigan,  48201,  United States
      Odyssey Research, Dearborn,  Michigan,  48126,  United States
Missouri
      Center for Vaccine Development, St. Louis,  Missouri,  63110,  United States
Montana
      Bozeman Urgent Care Center, Bozeman,  Montana,  59715,  United States
Nebraska
      Creighton/UNMC Pediatric Infectious Disease, Omaha,  Nebraska,  68131,  United States
      Meridian Clinical Research, LLC, Omaha,  Nebraska,  68134,  United States
Nevada
      Henderson Pediatrics, Henderson,  Nevada,  89015,  United States
      Clinical Research Center of Nevada, Las Vegas,  Nevada,  89104,  United States
New Jersey
      Summit Pediatric Pulmonary, Summit,  New Jersey,  07901,  United States
New York
      Winthrop University Hospital, Mineola,  New York,  11501,  United States
      Barbara Dzierzek/PharmaTrials, Inc., Brooklyn,  New York,  11222,  United States
      CPMC Research Pharmacy, New York,  New York,  10032,  United States
      Elmwood Pediatrics, Rochester,  New York,  14620,  United States
      Clarkstown Pediatric Associates, Nanuet,  New York,  10954,  United States
      Montefiore Medical Center, Bronx,  New York,  10467,  United States
      Health Sciences Research Center, Cortland,  New York,  13045,  United States
      Northeast Pediatrics and Adolescent Medicine, Syracuse,  New York,  13210,  United States
      United Medical Associates, Binghamton,  New York,  13901,  United States
      Endwell Family Physicians, Endwell,  New York,  13760,  United States
      Jacobi Medical Center, Bronx,  New York,  10461,  United States
      University Rochester Medical Center, Rochester,  New York,  14642,  United States
North Carolina
      Boone Pediatric Center, Boone,  North Carolina,  28607,  United States
      University of North Carolina Department of Pediatrics, Chapel Hill,  North Carolina,  79599,  United States
      North Carolina Clinical Research, Raleigh,  North Carolina,  27607,  United States
      Ford, Simpson, Lively and Rice Pediatrics, Winston Salem,  North Carolina,  27103,  United States
      Purcell Clinic, Laurinburg,  North Carolina,  28352,  United States
      Sylva Pediatrics Associates, Sylva,  North Carolina,  28779,  United States
North Dakota
      Odyssey Research, Bismark,  North Dakota,  58501,  United States
      Dakota Clinic/Innovis Health, Fargo,  North Dakota,  58104,  United States
      Odyssey Research, Bismark,  North Dakota,  58501,  United States
Ohio
      Shelly Senders and Associates, University Heights,  Ohio,  44118,  United States
      Ohio Pediatrics, Huber Heights,  Ohio,  45424,  United States
      Cincinnati Children''''s Hospital Medical Center, Cincinnati,  Ohio,  45229,  United States
      Pediatric Associates of Mt. Carmel, Cincinnati,  Ohio,  45245,  United States
Oklahoma
      Grand Prairie Pediatric and Allergy Clinic, Oklahoma City,  Oklahoma,  73132,  United States
      Hillcrest Medical Group/Utica Park Clinic, Tulsa,  Oklahoma,  74104,  United States
Pennsylvania
      Allegheny General Hospital, Pittsburg,  Pennsylvania,  15212,  United States
      Primary Physicians Research Inc., Pittsburg,  Pennsylvania,  15241-3100,  United States
      Children''''s Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15123,  United States
      Asthma & Allergy Research Associates, Upland,  Pennsylvania,  19013,  United States
Rhode Island
      Omega Medical Research, Cranston,  Rhode Island,  02920,  United States
      East Bay Pediatrics, Barrington,  Rhode Island,  02806,  United States
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States
South Dakota
      Northridge Brown Clinic, Watertown,  South Dakota,  57201,  United States
Tennessee
      Holston Medical Group Pediatrics, Kingsport,  Tennessee,  37660,  United States
      Medsouth Healthcare, Dyersburg,  Tennessee,  38024,  United States
      Murfressboro Medical Clinic, Murfreesboro,  Tennessee,  37130,  United States
      Pediatric Clincal Research Office, Nashville,  Tennessee,  37232-2573,  United States
Texas
      Benchmark Research, San Angelo,  Texas,  76904,  United States
      Healthfirst Medical Group, Fort Worth,  Texas,  76135,  United States
      Med-Pro Research Inc., Houston,  Texas,  77004,  United States
      Pediatric Allergy/Immunology Associates, PA, Dallas,  Texas,  75230,  United States
      Rd Clinical Research Inc., Lake Jackson,  Texas,  77566,  United States
      Wells Branch Medical Center, Austin,  Texas,  78728,  United States
      Sadler Clinic/Healthsouth Clinical Research, Conroe,  Texas,  77304,  United States
      Scott and White/Pediatric Clinic, Killeen,  Texas,  76451,  United States
      Quality Assurance Research Center, San Antonio,  Texas,  78207,  United States
      Central Texas Health Research, New Braunfels,  Texas,  78130,  United States
Utah
      J. Lewis Research Inc., Salt Lake City,  Utah,  84109,  United States
      Cottonwood Pediatrics, Murray,  Utah,  84107,  United States
      Alpine Pediatrics, Pleasant Grove,  Utah,  84062,  United States
      Utah Valley Pediatrics, Provo,  Utah,  84604,  United States
      Wee Care Pediatrics, Layton,  Utah,  84041,  United States
      Bear Care Pediatrics, Ogden,  Utah,  84450,  United States
      J. Lewis Research/Southwest Family Medicine, West Jordan,  Utah,  84084,  United States
      J. Lewis Research, Inc., Salt Lake City,  Utah,  84121,  United States
      Families First Pediatrics, South Jordan,  Utah,  84095,  United States
Virginia
      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
      Health Research of Hampton Roads, Inc, Newport News,  Virginia,  23606,  United States
      PI-Coor Clinical Research, LLC, Burke,  Virginia,  22015,  United States
      Respiratory Disease Study Unit, Charlottesville,  Virginia,  22901,  United States
West Virginia
      Univeristy Pediatrics, Huntington,  West Virginia,  25701,  United States
Wisconsin
      Monroe Medical Foundation, Monroe,  Wisconsin,  53566,  United States
Belgium
      Sint-Vincentiusziekenhuis Sint-Vincentiusstraat, Antwerp,  2018,  Belgium
      Private Practice, Wondelgem,  9032,  Belgium
      Private Practice, Schoten,  2900,  Belgium
      KUL Dienst Jeugdgezondheidszorg, Leuven,  3000,  Belgium
      Private Practice, Drongen,  9031,  Belgium
      Private Practice, Tienen,  3300,  Belgium
      AZ-VUB Paediatric Clinic, Brussel,  1090,  Belgium
      Private Practice, Berchem,  2600,  Belgium
      UVC Brugmann, Brussel,  1030,  Belgium
Czech Republic
      IN Boskovice a. s. Detské oddelení, Boskovice,  680 21,  Czech Republic
      Privátní praxe praktického lékare pro deti a dorost Lysice, Lysice,  679 71,  Czech Republic
      STOPED s.r.o., Plzen,  301 66,  Czech Republic
      Nemocnice s poliklinikou v Moste, Most,  434 64,  Czech Republic
      In Boskovice a.s. Detske oddeleni, Boskovice,  680 21,  Czech Republic
      Privantni praxe praktickenho, Lysice,  679 71,  Czech Republic
Hong Kong
      Department of Pediactrics, Shatin,  Hong Kong
      Department of Pediatrics - Paediatrics Unit, Kowloon,  Hong Kong
      Department of Pediatrics/Adolescent Medicine, Hang Hau,  Hong Kong
      Department of Pediatrics/Adolescent Medicine, Lai Chi Kok,  Hong Kong
      Department of Pediatrics, Chai Wan,  Hong Kong
Ireland
      Nottinghill Practice, Whiteabbey Health Centre, Whiteabbey,  BT37 9QN,  Ireland
      Springhill Surgery, Bangor County,  BT 19 1PP,  Ireland
      Randalstown Health Centre, Randalsotown,  BT413AE,  Ireland
Korea, Republic of
      Dept. of Pediatrics, Seoul,  130-702,  Korea, Republic of
      Department of Pediatrics, Seoul,  120-752,  Korea, Republic of
      Department of Pediatrics, Seoul,  152-703,  Korea, Republic of
      Department of Pediatrics, Seoul,  135-230,  Korea, Republic of
Taiwan
      Department of Pediatrics, Taipei,  100,  Taiwan
      Department of Pediatrics, Taipei,  104,  Taiwan
      Department of Pediatrics, Taoyuan,  333,  Taiwan
      Department of Pediatrics, Taichung,  403,  Taiwan
      Department of Pediatrics, Changhua,  500,  Taiwan
United Kingdom
      Sherbourne Medical Centre, Warwick Shire,  CV324RA,  United Kingdom
      Avondale Surgery Research, Chesterfield,  S404TF,  United Kingdom
      Gabels Medical Centre, Coventry,  CV6 4DD,  United Kingdom
      Valleyfield Health Centre, Fife,  KY128SJ,  United Kingdom
      Castlemilk Health Centre, Glasgow,  G459AW,  United Kingdom
      Saltash Health Centre, Cornwall,  PL12 4BU,  United Kingdom
      Woolwell Medical Centre, Devon Plymouth,  Unknown,  United Kingdom
      Govind Health Cenre, Coventry,  Cv66 4DD,  United Kingdom
      Knowle House Surgery, Plymouth,  PL5 3JD,  United Kingdom
      Landsdowne Road Yaxley, Peterborough,  PE7 3JL,  United Kingdom
      Layton Medical Centre, Lancs,  FY37EN,  United Kingdom
      The Staploe Medical Centre, Cambs,  CB7 5JD,  United Kingdom
      Woodend Health Centre, 676 Deedmore Road,  CV21AX,  United Kingdom
      The Medical Centre, East Horley,  KT246QT,  United Kingdom
      The Orchard Medical Centre, Bristol,  BS15 2NJ,  United Kingdom
      Cathcart Street Practice, Ayr,  KA71BJ,  United Kingdom
      Stonehill Medical Centre, Bolton,  BL49Q2,  United Kingdom
      Townhead Surgery, Ayrshire,  KA12 0AY,  United Kingdom
      Kingsway Medical, Glasgow,  Unknown,  United Kingdom
      Greenwood & Sneinton Family Medical Practice, Nottingham,  NG37DQ,  United Kingdom
      Wansford Surgery, Wansford,  PE86LP,  United Kingdom
United Kingdom, South Yorks
      Ashville Medical Center, Barnsely,  South Yorks,  S703RJ,  United Kingdom

Study ID Numbers:  MI-CP111
Last Updated:  August 8, 2005
Record first received:  August 5, 2005
ClinicalTrials.gov Identifier:  NCT00128167
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23