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CompletedNCT00128167Updated Sep 13, 2021

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

A Phase 3 interventional study of Liquid CAIV-T in Influenza, sponsored by MedImmune LLC. Completed at 161 sites in 8 countries. Open to participants aged 6 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-13.

Sponsored by MedImmune LLC · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
8,500
Allocation
Randomized
Ages
6 Months to 59 Months
Sex
All
01

Study summary

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

02

Conditions studied

  • Influenza

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 8,500 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
8,500 participants

Interventions

  • DrugLiquid CAIV-T
06

What researchers measure

Primary outcomes

  1. The primary efficacy endpoint of this study is the relative efficacy of CAIV-T

  2. 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

  3. influenza surveillance period and at least 14 days after the last required vaccination

Secondary outcomes

  1. Culture-confirmed symptomatic influenza infection regardless of antigenic match

  2. Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection antigenically similar to vaccine strains

  3. Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection regardless of antigenic match

  4. Lower respiratory illness (LRI) with culture-confirmed influenza infection antigenically similar to vaccine strains and

  5. Lower respiratory illness (LRI) with culture-confirmed influenza infection regardless of antigenic match

07

Study locations

161 sites
  • 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, 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
    Saint 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
  • Jacobi Medical Center
    Bronx, New York 10461, United States
  • Montefiore Medical Center
    Bronx, New York 10467, 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
  • 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

Showing the first 100 of 161 sites across 8 countries.

08

References and documents

Publications

  • 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. Erratum In: N Engl J Med. 2007 Mar 22;356(12):1283. PubMed 17301299 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00128167
Lead sponsor
MedImmune LLC
First posted
Aug 9, 2005
Start date
Oct 2004
Completion
Dec 2005
Last update
Sep 13, 2021

Study contacts

Robert Walker, M.D.
study director · MedImmune LLC
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

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