Clinical Trial: 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

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

This study is no longer recruiting patients.

Sponsored by: MedImmune, Inc.
Information provided by: MedImmune, Inc.
ClinicalTrials.gov Identifier: NCT00128167

Purpose

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

MedlinePlus related topics:  Influenza

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Safety Study

Eligibility

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.

Location Information


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

More Information

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

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