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HealthyNCT00639418

A Study to Describe Pediatric Influenza Vaccine Coverage

An observational study of Healthy, run by MedImmune LLC at 187 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to describe flu vaccine coverage in children under 18 years of age and to examine correlations between in-office flu vaccine coverage and the use of various tactics to increase vaccine coverage. Read more about this study

Who is it for?
Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Influenza vaccination
Type of treatment
Vaccines
How many people
147,494 participants
Where
187 sitesUnited States
Study dates
Aug 2007to Jun 2011
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Physician offices that were selected to participate in the study

Sites selected to participate were required to be able to accurately identify the number of patients under their care by age group and provide influenza vaccine at their location.

Trial locations and contacts

187 sites in 1 country.

187 sites in 1 country

United States187 sites
  • Van Dorn Pediatrics

    Alexandria, Virginia, 22302

  • Asheboro Research Associates

    Asheboro, North Carolina, 27203

  • Asheville Pediatric Association

    Asheville, North Carolina, 28803

  • JFK Pediatrics

    Atlantis, Florida, 33462

  • Associates in Pediatrics

    Baton Rouge, Louisiana, 70806

  • Community Pediatrics

    Beaver Dam, Wisconsin, 53916

  • Gardens Medical Center

    Bell Gardens, California, 90201

  • Bellevue Pediatrics

    Bellevue, Pennsylvania, 15202

  • Central Arkansas Pediatric Clinic

    Benton, Arkansas, 72019

  • Bentonville Pediatrics

    Bentonville, Arkansas, 72172

  • Children's Investigational Research Program

    Bentonville, Arkansas, 72712

  • Blue Ridge Pediatric and Adolescent Medicine

    Beone, North Carolina, 28607

  • Mecosta Health Services

    Big Rapids, Michigan, 49307

  • Ark-La-Tex Pediatric Research

    Birmingham, Alabama, 35242

  • Ark-La-Tex Pediatric Research

    Bossier City, Louisiana, 71111

  • Giangreco, Scarano & Taylor Pediatrics

    Bradenton, Florida, 34207

  • Kids and More Pediatric Care

    Brandon, Florida, 33511

  • Tots Thru Teens

    Bridgeton, Missouri, 63044

  • Jorge A Patino MD PA

    Brownsville, Texas, 78526

  • Cornerstone Medical Center

    Burlington, North Carolina, 27215

  • Kids First Pediatrics

    Canfield, Ohio, 44406

  • Shipley Child Health Clinic

    Canton, Ohio, 44704

  • Stark Pediatrics Inc.

    Canton, Ohio, 44708

  • Cary Medical Research

    Cary, North Carolina, 27518

  • MercyCare Edgewood

    Cedar Rapids, Iowa, 52404

  • Pendleton Pediatrics

    Chandler, Arizona, 85224

  • Coastal Pediatric Associates

    Charleston, South Carolina, 29414

  • Anderson Hills Pediatrics, Inc.

    Cincinnati, Ohio, 45230

  • Pediatric Associates of Mt. Carmel

    Cincinnati, Ohio, 45245

  • Four Seasons Pediatrics

    Clifton Park, New York, 12065

  • Haywood Pediatrics

    Clyde, North Carolina, 28721

  • KidCare Pediatrics, LLC

    College Park, Georgia, 30349

  • PMA Medical Specialists, LLC

    Collegeville, Pennsylvania, 19426

  • Coppell Pediatrics

    Coppell, Texas, 75019

  • Sawgrass Pediatrics

    Coral Springs, Florida, 33065

  • Alegent Health Clinic

    Council Bluffs, Iowa, 51503

  • Pratima Patel, MD

    Covina, California, 91723

  • Plateau Pediatrics

    Crossville, Tennessee, 38555

  • Siskiyou Pediatric Clinic, LLP

    Crossville, Tennessee, 38555

  • Sarah L. Helfand, M.D.

    Dallas, Texas, 75208

  • Healthy Texan Pediatrics and Family Medicine

    Dallas, Texas, 75230

  • Jordan Ridge Kids and Teens

    Daphne, Alabama, 36526

  • Pediatrics by the Bay

    Daphne, Alabama, 36526

  • Darien Pediatric Associates

    Darien, Connecticut, 06820

  • DuPage Pediatrics

    Darien, Illinois, 60561

  • Deckerville Health Services

    Deckerville, Michigan, 48427

  • Delmar Family Medicine

    Delmar, New York, 12054

  • Prime Care Physicians

    Delmar, New York, 12054

  • Pediatric Partners of the Southwest

    Durango, Colorado, 81301

  • Mediterranean Pediatrics

    East Orange, New Jersey, 07018

  • Evergreen Pediatrics

    Evergreen, Colorado, 80439

  • Alzein Pediatrics

    Evergreen Park, Illinois, 60805

  • Pediatric Associates of Fairfield

    Fairfield, Ohio, 45014

  • Perinton Pediatrics

    Fairport, New York, 14450

  • Park Pediatrics

    Floral Park, New York, 11001

  • Paul J. Janson, MD

    Florence, Kentucky, 41042

  • Mission Care Pediatrics

    Folsom, California, 95630

  • Pediatric Associates Inc

    Fort Wayne, Indiana, 46804

  • Cool Springs Pediatrics

    Franklin, Tennessee, 37067

  • Razia Sheikh

    Fresno, California, 93726

  • Iresh Kumar MD

    Frisco, Texas, 75034

  • Garden City Pediatric

    Garden City, New York, 11530

  • Ronald M. Frank, MD, PA

    Green Brook, New Jersey, 08812

  • Lucas Pediatrics

    Greensboro, North Carolina, 27405-6930

  • Briargate Medical Associates

    Greensboro, North Carolina, 27410

  • Northwest Pediatrics, Inc.

    Greensboro, North Carolina, 27410

  • Pediatric Associates of Gresham

    Gresham, Oregon, 97030

  • Henderson Pediatrics

    Henderson, Nevada, 89015

  • Anthem Pediatrics

    Henderson, Nevada, 89052

  • Rainbow Pediatrics

    Henderson, North Carolina, 28739

  • Blue Ridge Community Health Services

    Hendersonville, North Carolina, 28792

  • Ramon Maldonado, MD

    Homestead, Florida, 33030

  • Texas Childrens Pediatric Associates

    Houston, Texas, 77054

  • Pediatric Associates

    Houston, Texas, 77087

  • VIP Pediatrics

    Houston, Texas, 77205

  • Del Rosario Medical Clinic, Inc.

    Huntington Park, California, 90255

  • Northpoint Pediatrics

    Indianapolis, Indiana, 46256

  • Jeffersonville Pediatrics

    Jeffersonville, Indiana, 47130

  • Jesup Pediatrics

    Jesup, Georgia, 31545

  • Franklin Street Pediatrics

    Johnstown, Pennsylvania, 15905

  • Priority Care Pediatrics

    Kansas City, Missouri, 64155

  • King George Pediatrics

    King George, Virginia, 22485

  • Oldham County Pediatrics

    La Grange, Kentucky, 40031

  • Mary E. Lewis MD. PC

    LaGrange, Illinois, 60525

  • Family Practice Pediatric Clinic

    Lake Providence, Louisiana, 71254

  • Eden Park Pediatric

    Lancaster, Pennsylvania, 17601

  • Harold Naiman, MD

    Las Vegas, Nevada, 89128

  • St. John's Pediatrics

    Leavenworth, Kansas, 66048

  • Cumberland Pediatric Associates

    Lebanon, Tennessee, 37087

  • Preferred Pediatrics

    Lee's Summit, Missouri, 64086

  • Allstar Pediatrics (LEESVILLE, LA)

    Leesville, Louisiana, 71446

  • ProKids, LLP

    Levittown, New York, 11564

  • Lake Shore Pediatrics

    Libertyville, Illinois, 60048

  • Praful Bhatt, MD

    Lock Haven, Pennsylvania, 17745

  • Pediatric Associates of Lubbock

    Lubbock, Texas, 79424

  • Pediatric and Adolescent Healthcare, PC

    Marietta, Georgia, 30068

  • Cedar Creek Pediatrics & Adolescent Medicine

    Maryville, Tennessee, 37803

  • Landen Lake Pediatrics

    Mason, Ohio, 45040

  • Pediatrics South- Robinson

    McKees Rock, Pennsylvania, 15136

  • PMC

    McMinnville, Oregon, 97218

  • McMurray Pediatric & Adolescent Medicine

    McMurray, Pennsylvania, 15317

  • Johnson Pediatrics

    Medford, Oregon, 97504

  • Sheffield Pediatrics

    Memphis, Tennessee, 38104

  • Euclid Pediatrics

    Mentor, Ohio, 44060

  • Atlantic Coast Pediatrics

    Merrit Island, Florida, 32953

  • Guillermo S. Llosa, MD PA

    Miami, Florida, 33176

  • Woodlake Village Pediatrics

    Midlothian, Virginia, 23112

  • ESD Pediatric Group

    Milford, Ohio, 45150

  • Del Pilar Medical & Urgent Care Center

    Mishawaka, Indiana, 46545

  • Montgomery Pediatric Associates, PA

    Montgomery, Alabama, 36117

  • Pediatric Care Associates, LLC

    Montgomery, Texas, 77356

  • Mountain View Pediatrics, P.A.

    Morganton, North Carolina, 28655

  • The Pediatric Clinic, P.A.

    Mount Pleasant, Texas, 75455

  • Country Corner Family Medical Center

    Mount Vernon, Missouri, 65712

  • Palmetto Medical Research, LLC

    Mt. Pleasant, South Carolina, 29464

  • Pro Health Care Medical Associates

    Muskego, Wisconsin, 53150

  • Port City Pediatrics

    Muskegon, Illinois, 49444

  • Port City Pediatrics

    Muskegon, Michigan, 49444

  • Clarkstown Pediatrics

    New City, New York, 10956

  • The Pediatric Specialists Medical Group

    New Port Richey, Florida, 34655

  • Plaza Pediatrics

    North Brunswick, New Jersey, 08902

  • The Pediatric Clinic

    North Little Rock, Arkansas, 72117

  • North Court Pediatrics

    North Syracuse, New York, 13212

  • Norwich Pediatric Group PC

    Norwich, Connecticut, 06360

  • Ching Ti, M.D.

    Oceanside, California, 92054

  • Lake Country Pediatrics

    Oconomowoc, Wisconsin, 53066

  • Jean Brown Research-Odgen Clinic

    Odgen, Utah, 84404

  • Midwest Allergy and Asthma Clinic

    Omaha, Nebraska, 68130

  • Orange Park Pediatrics

    Orange Park, Florida, 32073

  • Orchard Park Pediatrics

    Orchard Park, New York, 14127

  • Jo Anne Nielsen, MD

    Oregon City, Oregon, 97045

  • Utah Valley Pediatrics

    Orem, Utah, 84057

  • Red Lion Pediatrics

    Philadelphia, Pennsylvania, 19114

  • Mt. Airy Pediatrics, LLP

    Philadelphia, Pennsylvania, 19119

  • New Beginnings Pediatrics

    Phillipsburg, New Jersey, 08865

  • Armadillo Pediatrics

    Phoenix, Arizona, 85003

  • Pediatric Associates of North Texas

    Plano, Texas, 75075

  • Childrens Medical Association

    Plantation, Florida, 33324

  • Pomona Pediatrics

    Pomona, New York, 10970

  • Providence Pediatrics

    Poway, California, 92064

  • Prospect Family Practice

    Prospect, Connecticut, 06712

  • Lake Area Pediatrics

    Providence, Rhode Island, 02906

  • Children's Clinic of Pueblo

    Pueblo, Colorado, 81003

  • Cevallos & Moise Pediatrics

    Quakertown, Pennsylvania, 18951

  • Redmond Pediatrics

    Redmond, Washington, 98052

  • Richmond Pediatric Associates

    Richmond, Virginia, 23233

  • Sandy Plains Pediatrics

    Ringgold, Georgia, 30736

  • Edward Lewis, M.D., P.C.

    Rochester, New York, 14618

  • Masoud Ahdieh MD

    Rockingham, North Carolina, 28379

  • Merrillwood Pediatrics

    Royal Oak, Michigan, 48067

  • RMH Pediatrics

    Rushville, Indiana, 46173

  • ChildCare Associates

    San Antonio, Texas, 78212

  • Southwest Children's Research Associates, P.A.

    San Antonio, Texas, 78229

  • Stonestown Pediatrics

    San Francisco, California, 94132

  • Eugene I Litwer

    Santa Ana, California, 92705

  • Grayhawk Pediatrics

    Scottsdale, Arizona, 85255

  • North Scottsdale Pediatrics Associates

    Scottsdale, Arizona, 85258

  • Papago Buttes Pediatric Center PC

    Scottsdale, Arizona, 85258

  • Pennridge Pediatric Associates

    Sellersville, Pennsylvania, 18960

  • Tennessee Valley Pediatric Associates

    Sheffield, Alabama, 35660

  • Pearl Acres Pediatrics

    Slidell, Louisiana, 70461

  • Zaman Pediatric Center

    Snellville, Georgia, 30078

  • Soddy Daisy Pediatrics

    Soddy-Daisy, Tennessee, 37379

  • Elizabeth A. Tomeo, MD

    Spokane, Washington, 99208

  • St Pete Pediatrics

    St. Pete Beach, Florida, 33709

  • Lynne Ellis

    St. Petersburg, Florida, 33705

  • Stafford Pediatrics, P.C.

    Stafford, Virginia, 22554-1545

  • Tejas Pediatrics

    Tejas, Texas, 78258

  • Crown Point Pediatrics

    Toledo, Ohio, 43617

  • Cholla Pediatrics

    Tucson, Arizona, 85741

  • Pediatric Clinical Trials, LLC

    Tullahoma, Tennessee, 37388

  • Northern Lights Pediatrics

    Vadnais Heights, Minnesota, 55110

  • Louella Peckson, MD

    Van Nuys, California, 91405

  • North Suburban Family Healthcare

    Vernon Hills, Illinois, 60061

  • Pediatric Associates of New Jersey

    Vineland, New Jersey, 08360

  • Adventures in Pediatrics

    Wasilla, Alaska, 99654

  • Adventures in Pediatrics

    Wasilla, Arkansas, 99654

  • A Brighter Tomorrow Pediatrics

    Webster, Texas, 77598

  • Sunshine Kids Medical Associates

    Webster, Texas, 77598

  • Wesley Chapel Internal Medicine & Pediatrics PA

    Wesley Chapel, Florida, 33544

  • Valle Verde Pediatrics

    West Jordan, Utah, 84088

  • Bay Street Pediatrics

    Westport, Connecticut, 06880

  • Carlile Pediatrics

    Wetumpka, Alabama, 36092

  • Columbus Pediatrics and Adolescent Care

    Whiteville, North Carolina, 28472

  • Susquehanna Int. Med. Pediatrics

    Williamsport, Pennsylvania, 17701

  • Piedmont Medical Research

    Winston-Salem, North Carolina, 27103

  • Pediatric Associates of Youngstown

    Youngstown, Ohio, 44505

Other trials in United States

About this study

Official title: An Observational Study to Describe Pediatric Influenza Vaccine Coverage Among Pediatricians in the United States

The purpose of this study is to describe flu vaccine coverage in children under 18 years of age and to examine correlations between in-office flu vaccine coverage and the use of various tactics to increase vaccine coverage.

Read the detailed description

To describe influenza vaccine coverage in children less than 18 years of age in practicing pediatricians' offices and family medicine physicians' offices and to examine correlations between in-office influenza vaccine coverage and the use of various tactics to increase vaccine coverage.

Conditions
Healthy
Being tested
Influenza vaccination

What participants receive

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

  • Influenza vaccinationBiological

    This non-interventional study prospectively captured vaccine coverage and practices of participating physician offices through use of surveys during the influenza vaccination season.

Study groups in NCT00639418
Study groupRoleWhat they receive
Participants 6 to 23 monthsPediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age
Receives: Biological: Influenza vaccination
Participants 24 to 59 monthsPediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age
Receives: Biological: Influenza vaccination
Participants 5 to 8 yearsPediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age
Receives: Biological: Influenza vaccination
Participants 9 to 17 yearsPediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age
Receives: Biological: Influenza vaccination

What is being measured

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

  1. Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices

    Vaccine coverage was calculated from the number of participants vaccinated in each group, divided by the total number of participants under the practice's care in that specific age group.

    Measured: Seasonal: 2007-2011

Secondary outcomes (2)
  1. Compliance With the Recommended Two-dose Regimen in Vaccinated Participants

    Compliance was calculated from the total number of participants receiving 2 doses divided by the total number of participants identified as requiring a second dose.

    Measured: Seasonal: 2007-2011

  2. Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage

    Correlation of office attitudes related to influenza vaccination and actual vaccine coverage was explored. Sites were asked to indicate level of agreement with the following recommendations: vaccinating children with high-risk medical conditions, patients 6 months to 5 years of age should be vaccinated against influenza each year, patients 5 to 18 years of age without high-risk medical conditions should be vaccinated against influenza each year, and previously unvaccinated patients less than 9 years of age receive 2 doses of vaccine.

    Measured: Seasonal: 2007-2011

Timeline

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

  1. First posted20 Mar 2008 (estimated)
  2. Study startAug 2007
  3. Primary completionMar 2011
  4. Study completionJun 2011

Resources

More details

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

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
147,494 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00639418
Sponsor's protocol ID
MI-MA156
Status last verified
Sep 2014
First submitted
4 Mar 2008
Last updated
15 Sep 2014
Data monitoring committee
No

Publications

  • Toback SL, Carr W, Hackell J, Bhatt P, Ryan A, Ambrose CS. Influenza vaccination of parents and guardians by US pediatricians. Hum Vaccin. 2011 Apr;7(4):436-40. doi: 10.4161/hv.7.4.14171. Epub 2011 Apr 1.

    PubMed 21445003
  • Bhatt P, Block SL, Toback SL, Ambrose CS. Timing of the availability and administration of influenza vaccine through the vaccines for children program. Pediatr Infect Dis J. 2011 Feb;30(2):100-6. doi: 10.1097/INF.0b013e3181efff54.

    PubMed 20686436
  • Bhatt P, Block SL, Toback SL, Ambrose CS. A prospective observational study of US in-office pediatric influenza vaccination during the 2007 to 2009 influenza seasons: use and factors associated with increased vaccination rates. Clin Pediatr (Phila). 2010 Oct;49(10):954-63. doi: 10.1177/0009922810370868. Epub 2010 Jun 3.

    PubMed 20522609

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by MedImmune LLC at 187 sites in United States.

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

Who may be eligible to take part?

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 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices (time frame: Seasonal: 2007-2011). 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 NCT00639418, which also lists 3 linked publications.

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 15 Sep 2014.

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