NCT00639418

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147,494

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

187 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

September 15, 2014

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

3.6 years

First QC Date

March 4, 2008

Results QC Date

January 10, 2014

Last Update Submit

September 12, 2014

Conditions

Outcome Measures

Primary Outcomes (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.

    Seasonal: 2007-2011

Secondary Outcomes (2)

  • Compliance With the Recommended Two-dose Regimen in Vaccinated Participants

    Seasonal: 2007-2011

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

    Seasonal: 2007-2011

Study Arms (4)

Participants 6 to 23 months

Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 6 to 23 months of age

Biological: Influenza vaccination

Participants 24 to 59 months

Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 24 to 59 months of age

Biological: Influenza vaccination

Participants 5 to 8 years

Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 5 to 8 years of age

Biological: Influenza vaccination

Participants 9 to 17 years

Pediatric influenza vaccine coverage within practicing pediatricians' offices for participants 9 to 17 years of age

Biological: Influenza vaccination

Interventions

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

Participants 24 to 59 monthsParticipants 5 to 8 yearsParticipants 6 to 23 monthsParticipants 9 to 17 years

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (187)

Ark-La-Tex Pediatric Research

Birmingham, Alabama, 35242, United States

Location

Jordan Ridge Kids and Teens

Daphne, Alabama, 36526, United States

Location

Pediatrics by the Bay

Daphne, Alabama, 36526, United States

Location

Montgomery Pediatric Associates, PA

Montgomery, Alabama, 36117, United States

Location

Tennessee Valley Pediatric Associates

Sheffield, Alabama, 35660, United States

Location

Carlile Pediatrics

Wetumpka, Alabama, 36092, United States

Location

Adventures in Pediatrics

Wasilla, Alaska, 99654, United States

Location

Pendleton Pediatrics

Chandler, Arizona, 85224, United States

Location

Armadillo Pediatrics

Phoenix, Arizona, 85003, United States

Location

Grayhawk Pediatrics

Scottsdale, Arizona, 85255, United States

Location

North Scottsdale Pediatrics Associates

Scottsdale, Arizona, 85258, United States

Location

Papago Buttes Pediatric Center PC

Scottsdale, Arizona, 85258, United States

Location

Cholla Pediatrics

Tucson, Arizona, 85741, United States

Location

Central Arkansas Pediatric Clinic

Benton, Arkansas, 72019, United States

Location

Bentonville Pediatrics

Bentonville, Arkansas, 72172, United States

Location

Children's Investigational Research Program

Bentonville, Arkansas, 72712, United States

Location

The Pediatric Clinic

North Little Rock, Arkansas, 72117, United States

Location

Adventures in Pediatrics

Wasilla, Arkansas, 99654, United States

Location

Gardens Medical Center

Bell Gardens, California, 90201, United States

Location

Pratima Patel, MD

Covina, California, 91723, United States

Location

Mission Care Pediatrics

Folsom, California, 95630, United States

Location

Razia Sheikh

Fresno, California, 93726, United States

Location

Del Rosario Medical Clinic, Inc.

Huntington Park, California, 90255, United States

Location

Ching Ti, M.D.

Oceanside, California, 92054, United States

Location

Providence Pediatrics

Poway, California, 92064, United States

Location

Stonestown Pediatrics

San Francisco, California, 94132, United States

Location

Eugene I Litwer

Santa Ana, California, 92705, United States

Location

Louella Peckson, MD

Van Nuys, California, 91405, United States

Location

Pediatric Partners of the Southwest

Durango, Colorado, 81301, United States

Location

Evergreen Pediatrics

Evergreen, Colorado, 80439, United States

Location

Children's Clinic of Pueblo

Pueblo, Colorado, 81003, United States

Location

Darien Pediatric Associates

Darien, Connecticut, 06820, United States

Location

Norwich Pediatric Group PC

Norwich, Connecticut, 06360, United States

Location

Prospect Family Practice

Prospect, Connecticut, 06712, United States

Location

Bay Street Pediatrics

Westport, Connecticut, 06880, United States

Location

JFK Pediatrics

Atlantis, Florida, 33462, United States

Location

Giangreco, Scarano & Taylor Pediatrics

Bradenton, Florida, 34207, United States

Location

Kids and More Pediatric Care

Brandon, Florida, 33511, United States

Location

Sawgrass Pediatrics

Coral Springs, Florida, 33065, United States

Location

Ramon Maldonado, MD

Homestead, Florida, 33030, United States

Location

Atlantic Coast Pediatrics

Merrit Island, Florida, 32953, United States

Location

Guillermo S. Llosa, MD PA

Miami, Florida, 33176, United States

Location

The Pediatric Specialists Medical Group

New Port Richey, Florida, 34655, United States

Location

Orange Park Pediatrics

Orange Park, Florida, 32073, United States

Location

Childrens Medical Association

Plantation, Florida, 33324, United States

Location

St Pete Pediatrics

St. Pete Beach, Florida, 33709, United States

Location

Lynne Ellis

St. Petersburg, Florida, 33705, United States

Location

Wesley Chapel Internal Medicine & Pediatrics PA

Wesley Chapel, Florida, 33544, United States

Location

KidCare Pediatrics, LLC

College Park, Georgia, 30349, United States

Location

Jesup Pediatrics

Jesup, Georgia, 31545, United States

Location

Pediatric and Adolescent Healthcare, PC

Marietta, Georgia, 30068, United States

Location

Sandy Plains Pediatrics

Ringgold, Georgia, 30736, United States

Location

Zaman Pediatric Center

Snellville, Georgia, 30078, United States

Location

DuPage Pediatrics

Darien, Illinois, 60561, United States

Location

Alzein Pediatrics

Evergreen Park, Illinois, 60805, United States

Location

Mary E. Lewis MD. PC

LaGrange, Illinois, 60525, United States

Location

Lake Shore Pediatrics

Libertyville, Illinois, 60048, United States

Location

Port City Pediatrics

Muskegon, Illinois, 49444, United States

Location

North Suburban Family Healthcare

Vernon Hills, Illinois, 60061, United States

Location

Pediatric Associates Inc

Fort Wayne, Indiana, 46804, United States

Location

Northpoint Pediatrics

Indianapolis, Indiana, 46256, United States

Location

Jeffersonville Pediatrics

Jeffersonville, Indiana, 47130, United States

Location

Del Pilar Medical & Urgent Care Center

Mishawaka, Indiana, 46545, United States

Location

RMH Pediatrics

Rushville, Indiana, 46173, United States

Location

MercyCare Edgewood

Cedar Rapids, Iowa, 52404, United States

Location

Alegent Health Clinic

Council Bluffs, Iowa, 51503, United States

Location

St. John's Pediatrics

Leavenworth, Kansas, 66048, United States

Location

Paul J. Janson, MD

Florence, Kentucky, 41042, United States

Location

Oldham County Pediatrics

La Grange, Kentucky, 40031, United States

Location

Associates in Pediatrics

Baton Rouge, Louisiana, 70806, United States

Location

Ark-La-Tex Pediatric Research

Bossier City, Louisiana, 71111, United States

Location

Family Practice Pediatric Clinic

Lake Providence, Louisiana, 71254, United States

Location

Allstar Pediatrics (LEESVILLE, LA)

Leesville, Louisiana, 71446, United States

Location

Pearl Acres Pediatrics

Slidell, Louisiana, 70461, United States

Location

Mecosta Health Services

Big Rapids, Michigan, 49307, United States

Location

Deckerville Health Services

Deckerville, Michigan, 48427, United States

Location

Port City Pediatrics

Muskegon, Michigan, 49444, United States

Location

Merrillwood Pediatrics

Royal Oak, Michigan, 48067, United States

Location

Northern Lights Pediatrics

Vadnais Heights, Minnesota, 55110, United States

Location

Tots Thru Teens

Bridgeton, Missouri, 63044, United States

Location

Priority Care Pediatrics

Kansas City, Missouri, 64155, United States

Location

Preferred Pediatrics

Lee's Summit, Missouri, 64086, United States

Location

Country Corner Family Medical Center

Mount Vernon, Missouri, 65712, United States

Location

Midwest Allergy and Asthma Clinic

Omaha, Nebraska, 68130, United States

Location

Henderson Pediatrics

Henderson, Nevada, 89015, United States

Location

Anthem Pediatrics

Henderson, Nevada, 89052, United States

Location

Harold Naiman, MD

Las Vegas, Nevada, 89128, United States

Location

Mediterranean Pediatrics

East Orange, New Jersey, 07018, United States

Location

Ronald M. Frank, MD, PA

Green Brook, New Jersey, 08812, United States

Location

Plaza Pediatrics

North Brunswick, New Jersey, 08902, United States

Location

New Beginnings Pediatrics

Phillipsburg, New Jersey, 08865, United States

Location

Pediatric Associates of New Jersey

Vineland, New Jersey, 08360, United States

Location

Four Seasons Pediatrics

Clifton Park, New York, 12065, United States

Location

Delmar Family Medicine

Delmar, New York, 12054, United States

Location

Prime Care Physicians

Delmar, New York, 12054, United States

Location

Perinton Pediatrics

Fairport, New York, 14450, United States

Location

Park Pediatrics

Floral Park, New York, 11001, United States

Location

Garden City Pediatric

Garden City, New York, 11530, United States

Location

ProKids, LLP

Levittown, New York, 11564, United States

Location

Clarkstown Pediatrics

New City, New York, 10956, United States

Location

North Court Pediatrics

North Syracuse, New York, 13212, United States

Location

Orchard Park Pediatrics

Orchard Park, New York, 14127, United States

Location

Pomona Pediatrics

Pomona, New York, 10970, United States

Location

Edward Lewis, M.D., P.C.

Rochester, New York, 14618, United States

Location

Asheboro Research Associates

Asheboro, North Carolina, 27203, United States

Location

Asheville Pediatric Association

Asheville, North Carolina, 28803, United States

Location

Blue Ridge Pediatric and Adolescent Medicine

Beone, North Carolina, 28607, United States

Location

Cornerstone Medical Center

Burlington, North Carolina, 27215, United States

Location

Cary Medical Research

Cary, North Carolina, 27518, United States

Location

Haywood Pediatrics

Clyde, North Carolina, 28721, United States

Location

Lucas Pediatrics

Greensboro, North Carolina, 27405-6930, United States

Location

Briargate Medical Associates

Greensboro, North Carolina, 27410, United States

Location

Northwest Pediatrics, Inc.

Greensboro, North Carolina, 27410, United States

Location

Rainbow Pediatrics

Henderson, North Carolina, 28739, United States

Location

Blue Ridge Community Health Services

Hendersonville, North Carolina, 28792, United States

Location

Mountain View Pediatrics, P.A.

Morganton, North Carolina, 28655, United States

Location

Masoud Ahdieh MD

Rockingham, North Carolina, 28379, United States

Location

Columbus Pediatrics and Adolescent Care

Whiteville, North Carolina, 28472, United States

Location

Piedmont Medical Research

Winston-Salem, North Carolina, 27103, United States

Location

Kids First Pediatrics

Canfield, Ohio, 44406, United States

Location

Shipley Child Health Clinic

Canton, Ohio, 44704, United States

Location

Stark Pediatrics Inc.

Canton, Ohio, 44708, United States

Location

Anderson Hills Pediatrics, Inc.

Cincinnati, Ohio, 45230, United States

Location

Pediatric Associates of Mt. Carmel

Cincinnati, Ohio, 45245, United States

Location

Pediatric Associates of Fairfield

Fairfield, Ohio, 45014, United States

Location

Landen Lake Pediatrics

Mason, Ohio, 45040, United States

Location

Euclid Pediatrics

Mentor, Ohio, 44060, United States

Location

ESD Pediatric Group

Milford, Ohio, 45150, United States

Location

Crown Point Pediatrics

Toledo, Ohio, 43617, United States

Location

Pediatric Associates of Youngstown

Youngstown, Ohio, 44505, United States

Location

Pediatric Associates of Gresham

Gresham, Oregon, 97030, United States

Location

PMC

McMinnville, Oregon, 97218, United States

Location

Johnson Pediatrics

Medford, Oregon, 97504, United States

Location

Jo Anne Nielsen, MD

Oregon City, Oregon, 97045, United States

Location

Bellevue Pediatrics

Bellevue, Pennsylvania, 15202, United States

Location

PMA Medical Specialists, LLC

Collegeville, Pennsylvania, 19426, United States

Location

Franklin Street Pediatrics

Johnstown, Pennsylvania, 15905, United States

Location

Eden Park Pediatric

Lancaster, Pennsylvania, 17601, United States

Location

Praful Bhatt, MD

Lock Haven, Pennsylvania, 17745, United States

Location

Pediatrics South- Robinson

McKees Rock, Pennsylvania, 15136, United States

Location

McMurray Pediatric & Adolescent Medicine

McMurray, Pennsylvania, 15317, United States

Location

Red Lion Pediatrics

Philadelphia, Pennsylvania, 19114, United States

Location

Mt. Airy Pediatrics, LLP

Philadelphia, Pennsylvania, 19119, United States

Location

Cevallos & Moise Pediatrics

Quakertown, Pennsylvania, 18951, United States

Location

Pennridge Pediatric Associates

Sellersville, Pennsylvania, 18960, United States

Location

Susquehanna Int. Med. Pediatrics

Williamsport, Pennsylvania, 17701, United States

Location

Lake Area Pediatrics

Providence, Rhode Island, 02906, United States

Location

Coastal Pediatric Associates

Charleston, South Carolina, 29414, United States

Location

Palmetto Medical Research, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

Plateau Pediatrics

Crossville, Tennessee, 38555, United States

Location

Siskiyou Pediatric Clinic, LLP

Crossville, Tennessee, 38555, United States

Location

Cool Springs Pediatrics

Franklin, Tennessee, 37067, United States

Location

Cumberland Pediatric Associates

Lebanon, Tennessee, 37087, United States

Location

Cedar Creek Pediatrics & Adolescent Medicine

Maryville, Tennessee, 37803, United States

Location

Sheffield Pediatrics

Memphis, Tennessee, 38104, United States

Location

Soddy Daisy Pediatrics

Soddy-Daisy, Tennessee, 37379, United States

Location

Pediatric Clinical Trials, LLC

Tullahoma, Tennessee, 37388, United States

Location

Jorge A Patino MD PA

Brownsville, Texas, 78526, United States

Location

Coppell Pediatrics

Coppell, Texas, 75019, United States

Location

Sarah L. Helfand, M.D.

Dallas, Texas, 75208, United States

Location

Healthy Texan Pediatrics and Family Medicine

Dallas, Texas, 75230, United States

Location

Iresh Kumar MD

Frisco, Texas, 75034, United States

Location

Texas Childrens Pediatric Associates

Houston, Texas, 77054, United States

Location

Pediatric Associates

Houston, Texas, 77087, United States

Location

VIP Pediatrics

Houston, Texas, 77205, United States

Location

Pediatric Associates of Lubbock

Lubbock, Texas, 79424, United States

Location

Pediatric Care Associates, LLC

Montgomery, Texas, 77356, United States

Location

The Pediatric Clinic, P.A.

Mount Pleasant, Texas, 75455, United States

Location

Pediatric Associates of North Texas

Plano, Texas, 75075, United States

Location

ChildCare Associates

San Antonio, Texas, 78212, United States

Location

Southwest Children's Research Associates, P.A.

San Antonio, Texas, 78229, United States

Location

Tejas Pediatrics

Tejas, Texas, 78258, United States

Location

A Brighter Tomorrow Pediatrics

Webster, Texas, 77598, United States

Location

Sunshine Kids Medical Associates

Webster, Texas, 77598, United States

Location

Jean Brown Research-Odgen Clinic

Odgen, Utah, 84404, United States

Location

Utah Valley Pediatrics

Orem, Utah, 84057, United States

Location

Valle Verde Pediatrics

West Jordan, Utah, 84088, United States

Location

Van Dorn Pediatrics

Alexandria, Virginia, 22302, United States

Location

King George Pediatrics

King George, Virginia, 22485, United States

Location

Woodlake Village Pediatrics

Midlothian, Virginia, 23112, United States

Location

Richmond Pediatric Associates

Richmond, Virginia, 23233, United States

Location

Stafford Pediatrics, P.C.

Stafford, Virginia, 22554-1545, United States

Location

Redmond Pediatrics

Redmond, Washington, 98052, United States

Location

Elizabeth A. Tomeo, MD

Spokane, Washington, 99208, United States

Location

Community Pediatrics

Beaver Dam, Wisconsin, 53916, United States

Location

Pro Health Care Medical Associates

Muskego, Wisconsin, 53150, United States

Location

Lake Country Pediatrics

Oconomowoc, Wisconsin, 53066, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Chris Ambrose
Organization
MedImmune LLC

Study Officials

  • Chris Ambrose, M.D.

    MedImmune LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 20, 2008

Study Start

August 1, 2007

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

September 15, 2014

Results First Posted

September 15, 2014

Record last verified: 2014-09

Locations