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

September 10, 2021 updated by: MedImmune LLC

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

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

Study Overview

Status

Completed

Conditions

Influenza

Intervention / Treatment

Drug: Liquid CAIV-T

Study Type

Interventional

Enrollment

8500

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Antwerp, Belgium, 2018
    - Sint-Vincentiusziekenhuis Sint-Vincentiusstraat
  - Berchem, Belgium, 2600
    - Private practice
  - Brussel, Belgium, 1030
    - UVC Brugmann
  - Brussel, Belgium, 1090
    - AZ-VUB Paediatric Clinic
  - Drongen, Belgium, 9031
    - Private practice
  - Leuven, Belgium, 3000
    - KUL Dienst Jeugdgezondheidszorg
  - Schoten, Belgium, 2900
    - Private practice
  - Tienen, Belgium, 3300
    - Private practice
  - Wondelgem, Belgium, 9032
    - Private practice
Czechia
- - Boskovice, Czechia, 680 21
    - IN Boskovice a. s. Detské oddelení
  - Boskovice, Czechia, 680 21
    - In Boskovice a.s. Detske oddeleni
  - Lysice, Czechia, 679 71
    - Privantni praxe praktickenho
  - Lysice, Czechia, 679 71
    - Privátní praxe praktického lékare pro deti a dorost Lysice
  - Most, Czechia, 434 64
    - Nemocnice s poliklinikou v Moste
  - Plzen, Czechia, 301 66
    - STOPED s.r.o.
Hong Kong
- - Chai Wan, Hong Kong
    - Department of Pediatrics
  - Hang Hau, Hong Kong
    - Department of Pediatrics/Adolescent Medicine
  - Kowloon, Hong Kong
    - Department of Pediatrics - Paediatrics Unit
  - Lai Chi Kok, Hong Kong
    - Department of Pediatrics/Adolescent Medicine
  - Shatin, Hong Kong
    - Department of Pediactrics
Ireland
- - Bangor County, Ireland, BT 19 1PP
    - Springhill Surgery
  - Randalsotown, Ireland, BT413AE
    - Randalstown Health Centre
  - Whiteabbey, Ireland, BT37 9QN
    - Nottinghill Practice, Whiteabbey Health Centre
Korea, Republic of
- - Seoul, Korea, Republic of, 120-752
    - Department of Pediatrics
  - Seoul, Korea, Republic of, 130-702
    - Dept. of Pediatrics
  - Seoul, Korea, Republic of, 135-230
    - Department of Pediatrics
  - Seoul, Korea, Republic of, 152-703
    - Department of Pediatrics
Taiwan
- - Changhua, Taiwan, 500
    - Department of Pediatrics
  - Taichung, Taiwan, 403
    - Department of Pediatrics
  - Taipei, Taiwan, 100
    - Department of Pediatrics
  - Taipei, Taiwan, 104
    - Department of Pediatrics
  - Taoyuan, Taiwan, 333
    - Department of Pediatrics
United Kingdom
- - Ayr, United Kingdom, KA71BJ
    - Cathcart Street Practice
  - Ayrshire, United Kingdom, KA12 0AY
    - Townhead Surgery
  - Bolton, United Kingdom, BL49Q2
    - Stonehill Medical Centre
  - Bristol, United Kingdom, BS15 2NJ
    - The Orchard Medical Centre
  - Cambs, United Kingdom, CB7 5JD
    - The Staploe Medical Centre
  - Chesterfield, United Kingdom, S404TF
    - Avondale Surgery Research
  - Cornwall, United Kingdom, PL12 4BU
    - Saltash Health Centre
  - Coventry, United Kingdom, CV2 1XA
    - Woodend Health Centre
  - Coventry, United Kingdom, CV6 4DD
    - Gabels Medical Centre
  - Coventry, United Kingdom, Cv66 4DD
    - Govind Health Cenre
  - Devon Plymouth, United Kingdom
    - Woolwell Medical Centre
  - East Horley, United Kingdom, KT246QT
    - The Medical Centre
  - Fife, United Kingdom, KY128SJ
    - Valleyfield Health Centre
  - Glasgow, United Kingdom, G459AW
    - Castlemilk Health Centre
  - Glasgow, United Kingdom
    - Kingsway Medical
  - Lancs, United Kingdom, FY37EN
    - Layton Medical Centre
  - Nottingham, United Kingdom, NG37DQ
    - Greenwood & Sneinton Family Medical Practice
  - Peterborough, United Kingdom, PE7 3JL
    - Landsdowne Road Yaxley
  - Plymouth, United Kingdom, PL5 3JD
    - Knowle House Surgery
  - Wansford, United Kingdom, PE86LP
    - Wansford Surgery
  - Warwick Shire, United Kingdom, CV324RA
    - Sherbourne Medical Centre
- South Yorks
  - Barnsely, South Yorks, United Kingdom, S703RJ
    - Ashville Medical Center
United States
- Alabama
  - Hoover, Alabama, United States, 35216
    - Clinical Research Consultants, Inc
  - Tuscaloosa, Alabama, United States, 35401
    - University of Alabama
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Little Rock Allergy and Asthma Clinical
- California
  - Anaheim, California, United States, 92805
    - Friendly Care Medical Group
  - Beverly Hills, California, United States, 90211
    - Impact Clinical Trials
  - Foothill Ranch, California, United States, 92610
    - Family Medical Center
  - Fountain Valley, California, United States, 92708-7504
    - Edinger Mecial Group
  - Fresno, California, United States, 93720
    - Fresno Childrens Medical Group, Inc.
  - Los Angeles, California, United States, 90015
    - Heathcare Partners Medical Group
  - Oakland, California, United States, 94612
    - Kaiser Permanente Vaccine Study Center
  - Rolling Hills Estates, California, United States, 90274
    - PRA Trials
  - San Francisco, California, United States, 94102
    - Benchmark Research
  - West Covina, California, United States, 91790
    - Convenience Care
- Connecticut
  - Norwich, Connecticut, United States, 06360
    - Norwich Pediatric Group, PC
- District of Columbia
  - Washington, District of Columbia, United States, 20057
    - Georgetown University Medical Center
- Florida
  - Miami, Florida, United States, 33156
    - Clinical Research Care & Resource Center, Inc
  - New Port Richey, Florida, United States, 34652
    - Suncoast Clinical Research
  - Palm Beach Gardens, Florida, United States, 33410
    - Pediatric Research Center of South Florida
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University School of Medicine, Dept of Pediatrics, Div of Infectious Diseases
  - Marietta, Georgia, United States, 30062
    - Pediatrics and Adolescent Medicine, P.A.
  - Martinez, Georgia, United States, 30907
    - Medical Parameters
- Illinois
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center/University Consultatnts in Allergy and Immunology
  - Chicago, Illinois, United States, 60641
    - Children's Memorial Hospital
  - Normal, Illinois, United States, 61761
    - Sneeze, Wheeze, & Itch Associates, LLC
- Indiana
  - South Bend, Indiana, United States, 46617
    - South Bend Clinic
- Kansas
  - Shawnee Mission, Kansas, United States, 66216
    - Heart of America Research Institute
  - Topeka, Kansas, United States, 66614
    - Heart of America Research Institute-Topeka
- Kentucky
  - Bardstown, Kentucky, United States, 40004
    - Kentucky Pediatrics/Adult Research Inc.
  - Louisville, Kentucky, United States, 40202
    - University Child Health Specialists, PCTU
- Louisiana
  - Bogalusa, Louisiana, United States, 70427
    - Clinical Trials Management, LLC/The Pediatric Clinic
  - New Orleans, Louisiana, United States, 70128
    - Dolby Providers LLC
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston University Medical Center
  - Woburn, Massachusetts, United States, 01801
    - Woburn Pediatric Associates
- Michigan
  - Dearborn, Michigan, United States, 48126
    - Odyssey Research
  - Detroit, Michigan, United States, 48201
    - Chidren's Hospital of Michigan
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - Center for Vaccine Development
- Montana
  - Bozeman, Montana, United States, 59715
    - Bozeman Urgent Care Center
- Nebraska
  - Omaha, Nebraska, United States, 68134
    - Meridian Clinical Research, LLC
  - Omaha, Nebraska, United States, 68131
    - Creighton/UNMC Pediatric Infectious Disease
- Nevada
  - Henderson, Nevada, United States, 89015
    - Henderson Pediatrics
  - Las Vegas, Nevada, United States, 89104
    - Clinical Research Center of Nevada
- New Jersey
  - Summit, New Jersey, United States, 07901
    - Summit Pediatric Pulmonary
- New York
  - Binghamton, New York, United States, 13901
    - United Medical Associates
  - Bronx, New York, United States, 10467
    - Montefiore Medical Center
  - Bronx, New York, United States, 10461
    - Jacobi Medical Center
  - Brooklyn, New York, United States, 11222
    - Barbara Dzierzek/PharmaTrials, Inc.
  - Cortland, New York, United States, 13045
    - Health Sciences Research Center
  - Endwell, New York, United States, 13760
    - Endwell Family Physicians
  - Mineola, New York, United States, 11501
    - Winthrop University Hospital
  - Nanuet, New York, United States, 10954
    - Clarkstown Pediatric Associates
  - New York, New York, United States, 10032
    - CPMC Research Pharmacy
  - Rochester, New York, United States, 14620
    - Elmwood Pediatrics
  - Rochester, New York, United States, 14642
    - University Rochester Medical Center
  - Syracuse, New York, United States, 13210
    - Northeast Pediatrics and Adolescent Medicine
- North Carolina
  - Boone, North Carolina, United States, 28607
    - Boone Pediatric Center
  - Chapel Hill, North Carolina, United States, 79599
    - University of North Carolina Department of Pediatrics
  - Laurinburg, North Carolina, United States, 28352
    - Purcell Clinic
  - Raleigh, North Carolina, United States, 27607
    - North Carolina Clinical Research
  - Sylva, North Carolina, United States, 28779
    - Sylva Pediatrics Associates
  - Winston-Salem, North Carolina, United States, 27103
    - Ford, Simpson, Lively and Rice Pediatrics
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Odyssey Research
  - Fargo, North Dakota, United States, 58104
    - Dakota Clinic/Innovis Health
- Ohio
  - Cincinnati, Ohio, United States, 45229
    - Cincinnati Children's Hospital Medical Center
  - Cincinnati, Ohio, United States, 45245
    - Pediatric Associates of Mt. Carmel
  - Huber Heights, Ohio, United States, 45424
    - Ohio Pediatrics
  - University Heights, Ohio, United States, 44118
    - Shelly Senders and Associates
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73132
    - Grand Prairie Pediatric and Allergy Clinic
  - Tulsa, Oklahoma, United States, 74104
    - Hillcrest Medical Group/Utica Park Clinic
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, United States, 15123
    - Children's Hospital of Pittsburgh
  - Pittsburgh, Pennsylvania, United States, 15241-3100
    - Primary Physicians Research Inc.
  - Upland, Pennsylvania, United States, 19013
    - Asthma & Allergy Research Associates
- Rhode Island
  - Barrington, Rhode Island, United States, 02806
    - East Bay Pediatrics
  - Cranston, Rhode Island, United States, 02920
    - Omega Medical Research
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
- South Dakota
  - Watertown, South Dakota, United States, 57201
    - Northridge Brown Clinic
- Tennessee
  - Dyersburg, Tennessee, United States, 38024
    - Medsouth Healthcare
  - Kingsport, Tennessee, United States, 37660
    - Holston Medical Group Pediatrics
  - Murfreesboro, Tennessee, United States, 37130
    - Murfressboro Medical Clinic
  - Nashville, Tennessee, United States, 37232-2573
    - Pediatric Clincal Research Office
- Texas
  - Austin, Texas, United States, 78728
    - Wells Branch Medical Center
  - Conroe, Texas, United States, 77304
    - Sadler Clinic/Healthsouth Clinical Research
  - Dallas, Texas, United States, 75230
    - Pediatric Allergy/Immunology Associates, PA
  - Fort Worth, Texas, United States, 76135
    - HealthFirst Medical Group
  - Houston, Texas, United States, 77004
    - Med-Pro Research Inc.
  - Killeen, Texas, United States, 76451
    - Scott and White/Pediatric Clinic
  - Lake Jackson, Texas, United States, 77566
    - Rd Clinical Research Inc.
  - New Braunfels, Texas, United States, 78130
    - Central Texas Health Research
  - San Angelo, Texas, United States, 76904
    - Benchmark Research
  - San Antonio, Texas, United States, 78207
    - Quality Assurance Research Center
- Utah
  - Layton, Utah, United States, 84041
    - Wee Care Pediatrics
  - Murray, Utah, United States, 84107
    - Cottonwood Pediatrics
  - Ogden, Utah, United States, 84450
    - Bear Care Pediatrics
  - Pleasant Grove, Utah, United States, 84062
    - Alpine Pediatrics
  - Provo, Utah, United States, 84604
    - Utah Valley Pediatrics
  - Salt Lake City, Utah, United States, 84109
    - J. Lewis Research Inc.
  - Salt Lake City, Utah, United States, 84121
    - J. Lewis Research, Inc.
  - South Jordan, Utah, United States, 84095
    - Families First Pediatrics
  - West Jordan, Utah, United States, 84084
    - J. Lewis Research/Southwest Family Medicine
- Virginia
  - Burke, Virginia, United States, 22015
    - PI-Coor Clinical Research, LLC
  - Charlottesville, Virginia, United States, 22901
    - Respiratory Disease Study Unit
  - Newport News, Virginia, United States, 23606
    - Health Research of Hampton Roads, Inc
  - Norfolk, Virginia, United States, 23510
    - Center for Pediatric Research
  - Richmond, Virginia, United States, 23219
    - VCU Campus Children's Pavilion/Pediatric Clinical Trials Office
  - Vienna, Virginia, United States, 22180-4224
    - Advanced Pediatrics
- West Virginia
  - Huntington, West Virginia, United States, 25701
    - Univeristy Pediatrics
- Wisconsin
  - Monroe, Wisconsin, United States, 53566
    - Monroe Medical Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

Outcome Measure
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Investigators

Study Director: Robert Walker, M.D., MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

August 5, 2005

First Submitted That Met QC Criteria

August 5, 2005

First Posted (Estimate)

August 9, 2005

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

MI-CP111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.