Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age | NCT00128167 | Trialant

Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age | NCT00128167 | Trialant

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
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.

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, 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