A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age

PHASE2CompletedINTERVENTIONAL
Enrollment

2,648

Participants

Timeline

Start Date

September 28, 2011

Primary Completion Date

May 8, 2014

Study Completion Date

May 8, 2014

Conditions
VaccinesMeningococcal Vaccines
Interventions
BIOLOGICAL

rLP2086 + MCV4 + Tdap

At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086.

BIOLOGICAL

MCV4 + Tdap + saline

At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only.

BIOLOGICAL

rLP2086 + saline

At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6).

Trial Locations (117)

13057

Child Health Care Associates, East Syracuse

22015

PI-Coor Clinical Research, LLC, Burke

22902

Pediatric Associates of Charlottesville, PLC, Charlottesville

22903

Pediatric Associates of Charlottesville, PLC - West Satellite, Charlottesville

22911

Pediatric Associates of Charlottesville, PLC - North Satellite, Charlottesville

27609

PMG Research of Raleigh, LLC -, Raleigh

PMG Research of Raleigh, LLC, Raleigh

27612

PMG Research of Raleigh, LLC, Raleigh

27704

Duke University Medical Center - Duke Health Center, Durham

Durham Pediatrics, Durham

27705

Duke Health Center, Durham

29401

Charleston Pediatrics, Charleston

29464

PMG Research of Charleson, Mt. Pleasant

29621

Radiant Research, Inc., Anderson

30062

Pediatrics and Adolescent Medicine, PA, Marietta

30189

Pediatrics and Adolescent Medicine, Woodstock

30322

Emory University School of Medicine Department of Pediatrics, Atlanta

Emory University School of Medicine, Atlanta

30342

Radiant Research, Inc, Atlanta

30721

North Georgia Clinical Research Center dba Whites Pediatrics, Dalton

33606

University of South Florida, Tampa

35209

Radiant Research, Inc., Birmingham

36526

Costal Clinical Research, Inc., Daphne

37203

Clinical Research Associates, Inc., Nashville

37620

Internal Medicine & Pediatric Associates of Bristol, PC, Bristol

PMG Research of Bristol, Bristol

40004

Kentucky Pediatric/Adult Research, Bardstown

40202

University of Louisville Pediatrics: Children and Youth Project, Louisville

40207

Brownsboro Park Pediatrics, Louisville

40291

Bluegrass Clinical Research, Inc., Louisville

43212

Radiant Research, Columbus

44121

Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics, Cleveland

Senders Pediatrics, Cleveland

44122

Rapid Medical Research, Inc., Cleveland

44311

Radiant Research, Inc, Akron

45206

Cincinnati Center for Clinical Research, Satellite Site - Clinic, Cincinnati

45414

Ohio Pediatric Research Association, Dayton

Ohio Pediatrics, Inc., Dayton

45420

Ohio Pediatric Research, Kettering

45424

Ohio Pediatrics, Inc., Huber Heights

49127

Southwestern Medical Clinic Lakeland Healthcare Affiliate, Stevensville

51503

Clinical Research Advantage, Inc./ Ridge Family Practice, PC, Council Bluffs

53566

Monroe Clinic, Monroe

54601

Gundersen Clinic, LTD, La Crosse

55108

Allina Health Bandana Square Clinic, Saint Paul

Aspen Medical Group/ Odyssey Research, Saint Paul

Aspen Medical Group, Saint Paul

58103

Innovis Health, Fargo

58104

Odyssey Research, Fargo

60115

Northern Illinois Research Associates, DeKalb

63104

Saint Louis University, St Louis

63141

Mercy Health Research, St Louis

Radiant Research, Inc., St Louis

Sundance Clinical Research, LLC, St Louis

64114

The Center for Pharmaceutical Research, PC, Kansas City

67010

Heartland Research Associates, LLC, Augusta

67207

Heartland Research Associates, LLC, Wichita

67208

Via Christi Clinic, P.A., Wichita

68025

Clinical Research Advantage, Inc. / Prairie Fields Family Medicine, PC, Fremont

68114

Quality Clinical Research, Inc., Omaha

68131

Creighton Pediatric Infectious Diseases Creighton University Medical Center, Omaha

68504

Midwest Children's Health Research Institute, Lincoln

72205

Arkansas Pediatric Clinic, Little Rock

72401

The Children's Clinic of Jonesboro, PA, Jonesboro

73036

Christopher Brad Redden, ARNP Healthcare One Urgent Care and Family Practice, El Reno

73069

Lynn Institute of Norman (LION), Norman

73112

Lynn Health Science Institute, Oklahoma City

74127

Oklahoma State University - Center for Health Sciences - Pediatric Research, Tulsa

75231

Radiant Research, Inc., Dallas

77030

Advances in Health Research, Inc, Houston

77055

West Houston Clinical Research Service, Houston

77065

Pediatric Healthcare of Northwest Houston, Houston

77070

Pediatric Healthcare of Northwest Houston, Houston

77081

Texas Center for Drug Development, Inc., Houston

77375

Pediatric Healthcare of Northwest Houston, PA, Tomball

Pediatric Healthcare of Northwest Houston, Tomball

78212

Child Care Associates, San Antonio

78229

Clinical Trials of Texas, Inc., San Antonio

Radiant Research, Inc., San Antonio

78254

First Steps Pediatrics, San Antonio

78745

Tekton Research, Inc., Austin

80239

Radiant Research, Inc., Denver

80907

Lynn Institute of the Rockies, Colorado Springs

80909

Colorado Springs Family Practice, Colorado Springs

83642

Advanced Clinical Research, Meridian

84088

Advanced Clinical Research, West Jordan

84095

J. Lewis Research, Inc. - Jordan River Family Medicine, South Jordan

84109

J. Lewis Resarch Incorporated, Foothill Family Clinic, Salt Lake City

84121

J. Lewis Research Inc. - Foothill Family Clinic South, Salt Lake City

84123

Radiant Research, Inc., Murray

84124

Jean Brown Research, Salt Lake City

85203

Clinical Research Advantage, Inc./Mesa Family Medical Center, PC, Mesa

85213

Clinical Research Advantage, Inc./Desert, Mesa

85224

Clinical Research Advantage Inc/ East Valley Family Physicians, PLC, Chandler

Radiant Research, Inc., Chandler

85710

Radiant Research, Inc., Tucson

85712

Radiant Research, Inc., Tucson

89014

Clinical Research Center of Nevada, Henderson

89105

Clinical Research Center of Nevada, Las Vegas

90723

Bayview Research Group, LLC, Paramount

Center for Clinical Trials, LLC, Paramount

91607

Bayview Research Group, LLC, Valley Village

92103

California Research Foundation, San Diego

92350

Loma Linda University, Loma Linda

92354

Loma Linda University Health Care Pediatric Clinic, Loma Linda

Loma Linda University Medical Center, Loma Linda

92557

Loma Linda University Health Care - Moreno Valley Pediatrics, Moreno Valley

92647

Pediatric Care Medical Group, Huntington Beach

93726

Kaiser Permanente Fresno, Fresno

94545

Kaiser Permanente Hayward, Hayward

95815

Kaiser Permanente Sacramento, Sacramento

98664

The Vancouver Clinic, Vancouver

98686

The Vancouver Clinic, Vancouver

06360

Norwich Pediatric Group, P.C., Norwich

45229-3039

Cincinnati Childrens Hospital Medical Center Gamble Program for Clinical Studies, Cincinnati

02920

Office of Richard Ohnmacht, Cranston

02886

Omega Medical Research, Warwick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01461980 - A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age | Biotech Hunter | Biotech Hunter