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InfluenzaPhase 3NCT00128167

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

A Phase 3 study testing Liquid CAIV-T in people with Influenza, run by MedImmune LLC at 161 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 6 to 59 monthsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Liquid CAIV-T
How many people
8,500 participants
Where
161 sitesin 8 countries
Study dates
Oct 2004to Dec 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 59 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

161 sites in 8 countries.

161 sites in 8 countries

United States107 sites

  • Friendly Care Medical Group

    Anaheim, California, 92805

  • Emory University School of Medicine, Dept of Pediatrics, Div of Infectious Diseases

    Atlanta, Georgia, 30322

  • Wells Branch Medical Center

    Austin, Texas, 78728

  • Kentucky Pediatrics/Adult Research Inc.

    Bardstown, Kentucky, 40004

  • East Bay Pediatrics

    Barrington, Rhode Island, 02806

  • Impact Clinical Trials

    Beverly Hills, California, 90211

  • United Medical Associates

    Binghamton, New York, 13901

  • Odyssey Research

    Bismarck, North Dakota, 58501

  • Clinical Trials Management, LLC/The Pediatric Clinic

    Bogalusa, Louisiana, 70427

  • Boone Pediatric Center

    Boone, North Carolina, 28607

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Urgent Care Center

    Bozeman, Montana, 59715

  • Barbara Dzierzek/PharmaTrials, Inc.

    Brooklyn, New York, 11222

  • PI-Coor Clinical Research, LLC

    Burke, Virginia, 22015

  • University of North Carolina Department of Pediatrics

    Chapel Hill, North Carolina, 79599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Respiratory Disease Study Unit

    Charlottesville, Virginia, 22901

  • Rush University Medical Center/University Consultatnts in Allergy and Immunology

    Chicago, Illinois, 60612

  • Children's Memorial Hospital

    Chicago, Illinois, 60641

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Pediatric Associates of Mt. Carmel

    Cincinnati, Ohio, 45245

  • Sadler Clinic/Healthsouth Clinical Research

    Conroe, Texas, 77304

  • Health Sciences Research Center

    Cortland, New York, 13045

  • Omega Medical Research

    Cranston, Rhode Island, 02920

  • Pediatric Allergy/Immunology Associates, PA

    Dallas, Texas, 75230

  • Odyssey Research

    Dearborn, Michigan, 48126

  • Chidren's Hospital of Michigan

    Detroit, Michigan, 48201

  • Medsouth Healthcare

    Dyersburg, Tennessee, 38024

  • Endwell Family Physicians

    Endwell, New York, 13760

  • Dakota Clinic/Innovis Health

    Fargo, North Dakota, 58104

  • Family Medical Center

    Foothill Ranch, California, 92610

  • Healthfirst Medical Group

    Fort Worth, Texas, 76135

  • Edinger Mecial Group

    Fountain Valley, California, 92708-7504

  • Fresno Childrens Medical Group, Inc.

    Fresno, California, 93720

  • Henderson Pediatrics

    Henderson, Nevada, 89015

  • Clinical Research Consultants, Inc

    Hoover, Alabama, 35216

  • Med-Pro Research Inc.

    Houston, Texas, 77004

  • Ohio Pediatrics

    Huber Heights, Ohio, 45424

  • Univeristy Pediatrics

    Huntington, West Virginia, 25701

  • Scott and White/Pediatric Clinic

    Killeen, Texas, 76451

  • Holston Medical Group Pediatrics

    Kingsport, Tennessee, 37660

  • Rd Clinical Research Inc.

    Lake Jackson, Texas, 77566

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89104

  • Purcell Clinic

    Laurinburg, North Carolina, 28352

  • Wee Care Pediatrics

    Layton, Utah, 84041

  • Little Rock Allergy and Asthma Clinical

    Little Rock, Arkansas, 72205

  • Heathcare Partners Medical Group

    Los Angeles, California, 90015

  • University Child Health Specialists, PCTU

    Louisville, Kentucky, 40202

  • Pediatrics and Adolescent Medicine, P.A.

    Marietta, Georgia, 30062

  • Medical Parameters

    Martinez, Georgia, 30907

  • Clinical Research Care & Resource Center, Inc

    Miami, Florida, 33156

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Monroe Medical Foundation

    Monroe, Wisconsin, 53566

  • Murfressboro Medical Clinic

    Murfreesboro, Tennessee, 37130

  • Cottonwood Pediatrics

    Murray, Utah, 84107

  • Clarkstown Pediatric Associates

    Nanuet, New York, 10954

  • Pediatric Clincal Research Office

    Nashville, Tennessee, 37232-2573

  • Central Texas Health Research

    New Braunfels, Texas, 78130

  • Dolby Providers LLC

    New Orleans, Louisiana, 70128

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • CPMC Research Pharmacy

    New York, New York, 10032

  • Health Research of Hampton Roads, Inc

    Newport News, Virginia, 23606

  • Center for Pediatric Research

    Norfolk, Virginia, 23510

  • Sneeze, Wheeze, & Itch Associates, LLC

    Normal, Illinois, 61761

  • Norwich Pediatric Group, PC

    Norwich, Connecticut, 06360

  • Kaiser Permanente Vaccine Study Center

    Oakland, California, 94612

  • Bear Care Pediatrics

    Ogden, Utah, 84450

  • Grand Prairie Pediatric and Allergy Clinic

    Oklahoma City, Oklahoma, 73132

  • Creighton/UNMC Pediatric Infectious Disease

    Omaha, Nebraska, 68131

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • Pediatric Research Center of South Florida

    Palm Beach Gardens, Florida, 33410

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15123

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Primary Physicians Research Inc.

    Pittsburgh, Pennsylvania, 15241-3100

  • Alpine Pediatrics

    Pleasant Grove, Utah, 84062

  • Utah Valley Pediatrics

    Provo, Utah, 84604

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • VCU Campus Children's Pavilion/Pediatric Clinical Trials Office

    Richmond, Virginia, 23219

  • Elmwood Pediatrics

    Rochester, New York, 14620

  • University Rochester Medical Center

    Rochester, New York, 14642

  • PRA Trials

    Rolling Hills Estates, California, 90274

  • J. Lewis Research Inc.

    Salt Lake City, Utah, 84109

  • J. Lewis Research, Inc.

    Salt Lake City, Utah, 84121

  • Benchmark Research

    San Angelo, Texas, 76904

  • Quality Assurance Research Center

    San Antonio, Texas, 78207

  • Benchmark Research

    San Francisco, California, 94102

  • Heart of America Research Institute

    Shawnee Mission, Kansas, 66216

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Families First Pediatrics

    South Jordan, Utah, 84095

  • Center for Vaccine Development

    St Louis, Missouri, 63110

  • Summit Pediatric Pulmonary

    Summit, New Jersey, 07901

  • Sylva Pediatrics Associates

    Sylva, North Carolina, 28779

  • Northeast Pediatrics and Adolescent Medicine

    Syracuse, New York, 13210

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Heart of America Research Institute-Topeka

    Topeka, Kansas, 66614

  • Hillcrest Medical Group/Utica Park Clinic

    Tulsa, Oklahoma, 74104

  • University of Alabama

    Tuscaloosa, Alabama, 35401

  • Shelly Senders and Associates

    University Heights, Ohio, 44118

  • Asthma & Allergy Research Associates

    Upland, Pennsylvania, 19013

  • Advanced Pediatrics

    Vienna, Virginia, 22180-4224

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20057

  • Northridge Brown Clinic

    Watertown, South Dakota, 57201

  • Convenience Care

    West Covina, California, 91790

  • J. Lewis Research/Southwest Family Medicine

    West Jordan, Utah, 84084

  • Ford, Simpson, Lively and Rice Pediatrics

    Winston-Salem, North Carolina, 27103

  • Woburn Pediatric Associates

    Woburn, Massachusetts, 01801

Other trials in United States

United Kingdom22 sites

  • Cathcart Street Practice

    Ayr, KA71BJ

  • Townhead Surgery

    Ayrshire, KA12 0AY

  • Ashville Medical Center

    Barnsely, South Yorks, S703RJ

  • Stonehill Medical Centre

    Bolton, BL49Q2

  • The Orchard Medical Centre

    Bristol, BS15 2NJ

  • The Staploe Medical Centre

    Cambs, CB7 5JD

  • Avondale Surgery Research

    Chesterfield, S404TF

  • Saltash Health Centre

    Cornwall, PL12 4BU

  • Woodend Health Centre

    Coventry, CV2 1XA

  • Gabels Medical Centre

    Coventry, CV6 4DD

  • Govind Health Cenre

    Coventry, Cv66 4DD

  • Woolwell Medical Centre

    Devon Plymouth

  • The Medical Centre

    East Horley, KT246QT

  • Valleyfield Health Centre

    Fife, KY128SJ

  • Castlemilk Health Centre

    Glasgow, G459AW

  • Kingsway Medical

    Glasgow

  • Layton Medical Centre

    Lancs, FY37EN

  • Greenwood & Sneinton Family Medical Practice

    Nottingham, NG37DQ

  • Landsdowne Road Yaxley

    Peterborough, PE7 3JL

  • Knowle House Surgery

    Plymouth, PL5 3JD

  • Wansford Surgery

    Wansford, PE86LP

  • Sherbourne Medical Centre

    Warwick Shire, CV324RA

Other trials in United Kingdom

Belgium9 sites

  • Sint-Vincentiusziekenhuis Sint-Vincentiusstraat

    Antwerp, 2018

  • Private Practice

    Berchem, 2600

  • UVC Brugmann

    Brussels, 1030

  • AZ-VUB Paediatric Clinic

    Brussels, 1090

  • Private Practice

    Drongen, 9031

  • KUL Dienst Jeugdgezondheidszorg

    Leuven, 3000

  • Private Practice

    Schoten, 2900

  • Private Practice

    Tienen, 3300

  • Private Practice

    Wondelgem, 9032

Other trials in Belgium

Czechia6 sites

  • IN Boskovice a. s. Detské oddelení

    Boskovice, 680 21

  • In Boskovice a.s. Detske oddeleni

    Boskovice, 680 21

  • Privantni praxe praktickenho

    Lysice, 679 71

  • Privátní praxe praktického lékare pro deti a dorost Lysice

    Lysice, 679 71

  • Nemocnice s poliklinikou v Moste

    Most, 434 64

  • STOPED s.r.o.

    Pilsen, 301 66

Other trials in Czechia

Hong Kong5 sites

  • Department of Pediatrics

    Chai Wan

  • Department of Pediatrics/Adolescent Medicine

    Hang Hau

  • Department of Pediatrics - Paediatrics Unit

    Kowloon

  • Department of Pediatrics/Adolescent Medicine

    Lai Chi Kok

  • Department of Pediactrics

    Shatin

Other trials in Hong Kong

Taiwan5 sites

  • Department of Pediatrics

    Changhua, 500

  • Department of Pediatrics

    Taichung, 403

  • Department of Pediatrics

    Taipei, 100

  • Department of Pediatrics

    Taipei, 104

  • Department of Pediatrics

    Taoyuan, 333

Other trials in Taiwan

South Korea4 sites

  • Department of Pediatrics

    Seoul, 120-752

  • Dept. of Pediatrics

    Seoul, 130-702

  • Department of Pediatrics

    Seoul, 135-230

  • Department of Pediatrics

    Seoul, 152-703

Other trials in South Korea

Ireland3 sites

  • Springhill Surgery

    Bangor County, BT 19 1PP

  • Randalstown Health Centre

    Randalsotown, BT413AE

  • Nottinghill Practice, Whiteabbey Health Centre

    Whiteabbey, BT37 9QN

Other trials in Ireland

About this study

Official title: 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.

Conditions
Influenza
Being tested
Liquid CAIV-T
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liquid CAIV-TDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 (5)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2005 (estimated)
  2. Study startOct 2004
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
8,500 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00128167
Sponsor's protocol ID
MI-CP111
Status last verified
Jul 2006
First submitted
5 Aug 2005
Last updated
13 Sep 2021
Results posted
No

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.

    PubMed 17301299

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Liquid CAIV-T in people with Influenza, run by MedImmune LLC at 161 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in United States, United Kingdom, Belgium, Czechia, Hong Kong and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy endpoint of this study is the relative efficacy of CAIV-T. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00128167, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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