Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers

PHASE3CompletedINTERVENTIONAL
Enrollment

1,630

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

July 31, 2010

Study Completion Date

October 31, 2010

Conditions
Meningococcal Infections
Interventions
BIOLOGICAL

MenACWY-CRM + MMRV

One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.

BIOLOGICAL

MMRV

one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age

BIOLOGICAL

MenACWY-CRM

Two injections of MenACWY-CRM at 7-9 months and 12 months of age; one injection of MMRV (Measles, Mumps, Rubella and Varicella) at 13.5 months of age

Trial Locations (90)

10467

Site 77 - Montefiore Medical Center 111 East 210th Street Rosenthall Building; 4th Floor, The Bronx

11501

Site 76 - Winthrop University Hospital Winthrop Pediatric Associates 120 Mineola Boulevard, Suite 210, Mineola

13210

Site 91 - SUNY Upstate Medical University 750 East Adams St,; Suite 5400, Syracuse

15090

Site 14 - CCP - Pittsburgh Pediatrics 6000 Brooktree Road Suite 207, Wexford

15217

Site 18 - Squirrel Hill Office 4070 Beechwood Blvd, Pittsburgh

15220

Site 21 - Pediatric Alliance Greentree Div. 969 Greentree Road Suite 100, Pittsburgh

15227

Site 20 - South Hill Pediatrics 4411 Stilley Road, Pittsburgh

15236

Site 17 - Pediatric Alliance, Southwestern, 850 Clairton Blvd, Pittsburgh

15237

Site 83 - Pediatric Alliance, PC Arcadia Division 9000 Perry Hwy; Suite 120, Pittsburgh

15241

Site 12 - Pediatric Alliance St. Clair 1580 McLaughlin Run Road, Pittsburgh

15401

Site 16 - Laurel Pediatrics 140 Wayland Smith Drive, Uniontown

15650

Site 19 - Pediatric Associates of Latrobe 210 Welson Street, Latrobe

16125

Site 15 - UPMC/ Community Medicine, Inc 90 Shenango Street, Greenville

16505

Site 13 - Children's Health Care- West 4671 West Lake Road, Erie

19026

Site 32 - Drexel Hill Pediatrics 5030 State Rd.; Suite 2-900, Drexel Hill

23219

Site 67 - Virginia Commonwealth Univ. 1001 East Marshall Street Room P008, Richmond

25701

Site 98 - University Physicians Internal Medicine 1600 Medical Center Drive, Huntington

27704

Site 28 - Duke Health Center at Roxboro Road 4020 North Roxboro Road, Durham

Site 29 - Regional Pediatrics 4022 Freedom Lake Drive, Durham

Site 30 - Durham Pediatrics 2609 North Duke Street Suite 100, Durham

32806

Site 47 - Department of Clinical Trials 1401Lucerne Terrace; MP141, Orlando

35205

Site 85 - Birmingham Pediatric Associates, 806 St. Vincent's Drive, Birmingham

36037

Site 00 - Veritas Research LLC/ Stabler Clinic, 300 North College Street,, Greenville

36106

Site 42 - Drug Research and Analysis Corporation, 1758 Parkplace, Suite 200, Montgomery

36305

Site 86 - Southeastern Pediatrics Associate, 364 Honeysuckle Road, Dothan

37043

Site 81 - Alpha Clinical Research, LLC 279 Clear Sky Court; Suite C, Clarksville

37075

Site 11 - Focus Research Group 242 West Main, Hendersonville

38305

Site 38 - Jackson Clinic 2683 Highway 45 Bypass North, Jackson

39216

Site 73 - University of MS Medical Ctr Pediatric Clinical Research 2500 North State St; 2 East-H255, Jackson

40004

Site 25 - Kentucky Pediatric/ Adult Research 201 South 5th Street Suite 102, Bardstown

40069

Site 68 - Physicians to Children/ Adolescents 102 West Depot Street, Springfield

40202

Site 74 - University of Louisville University Child Health Specialists 230 East Broadway, Louisville

Site 87 - University of Louisville Children & Youth Project 555 South Floyd Street, Louisville

40272

Site 88 - University of Louisville Univ. of Child Health Specialist So 9702 Stonestreet Road; Suite 100, Louisville

40291

Site 57 - Bluegrass Clinical Research, Inc. 5512 Bardstown Rd; Suite 2, Louisville

41017

Site 52 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 2865 Chancellor Drive, Crestview Hills

42303

Site 84 - Springs Medical Research, PLLC 2200 East Parrish Avenue Suite 101, Owensboro

44121

Site 62 - Dr. Senders and Assoc., Pediatrics 2054 South Green Road, Cleveland

44515

Site 82 - Austintown Pediatrics 107 Javit Court, Austintown

45229

Site 51 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 3333 Burnet Avenue; MLC 6014, Cincinnati

45406

Site 97 - Dayton Clinical Research 1100 Salem Avenue, Dayton

45415

Site 35 - Caro Pediatric Center 111 Turner Road, Dayton

45420

Site 27 - Ohio Pediatrics 1775 Delco Park Drive, Kettering

45424

Site 26 - Ohio Pediatrics 7371 Brandt Pike; Suite C, Huber Heights

49120

Site 96 - Southwestern Medical Clinic, PC 2002 South 11th Street, Niles

49127

Site 89 - Southwestern Medical Clinic 5515 Cleveland Ave.; Suite 1, Stevensville

53566

Site 64 - Monroe Medical Foundation Monroe Clinic 515 22nd Avenue, Monroe

54601

Site 92 - Gundersen Clinic, Ltd. 1836 South Ave.; Mailstop C03-006B, La Crosse

68123

Site 79 - Children's Physicians Bellevue 11507 S. 42nd Street, Bellevue

68131

Site 66 - Creighton University Department of Pediatrics 601 N. 30th St.; Suite 6820, Omaha

68132

Site 78 - Children's Physicians Dundee 119 North 51st Street, Omaha

70121

Site 63 - Ochsner Clinic Foundations, 1315 Jefferson Highway, New Orleans

71037

Site 93 - ACC Pediatric Research 1025 Highway 80 East, East Haughton

72034

Site 94 - Central Arkansas Pediatrics, 2425 Dave Ward Dr.; Suite 601, Conway

72205

Site 49 - Arkansas Pediatric Clinical Research, 500 S. University; Suite 200, Little Rock

72401

Site 80 - The Children's Clinic of Jonesboro, 800 S. Church St; Suite 400; 4th Fl, Jonesboro

72712

Site 56 - Children's Investigational Research Program, LLC, 2719 SE I Street, Bentonville

74127

Site 90 - OK State Univ-Ctr for Health Scienc Houston Parke Physicians 635 W. 11th StreetOklahoma State University - Center for Health Sciences, Tulsa

76107

Site 69 - University of North Texas Health Science Center 855 Montgomery Street, Fort Worth

77070

Site 36 - Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200, Houston

80233

Site 40 - 1st Allergy and Asthma Center 3260 E. 104th Ave.; Suite C, Thornton

Site 41 - 1st Immunology & Clinical Research 3260 East 104th Avenue, Thornton

84041

Site 43 - Wee Care Pediatrics 1580 W. Antelope Drive; Suite 100, Layton

Site 45 - Wee Care Pediatrics 934 South Main St.; Suite 8, Layton

84067

Site 44 - Wee Care Pediatrics 5991 South 3500 West; Suite 100 Rock Run Plaza, Roy

84095

Site 53 - Copperview Medical Center 3556 West 9800 South Suite 101, South Jordan

90502

Site 24 - UCLA Center for Vaccine Research 1124 W Carson St., Torrance

90723

Site 58 - Center for Clinical Trials, LLC 16660 Paramount Boulevard Suite 301, Paramount

Site 59 - Center for Clinical Trials, LLC 16415 S. Colorado Avevue Suite 308, Paramount

92350

Site 70 - Loma Linda University, Department of Pediatrics, 11175 Campus Street; CP A1120, Loma Linda

92557

Site 71 - LLUHC Moreno Valley Pediatrics, 11401 Heacock Street, Moreno Valley

92868

Site 72 - Children's Hospital of Orange Co. 455 South Main Street, Orange

93726

Site 08 - Kaiser Permanente Pediatric Clinic 4785 N. First Street 3rd Floor, Fresno

94015

Site 05 - Kaiser Permanente Pediatric Clinic 395 Hickory Blvd. 2nd Floor; Room 265, Daly City

94063

Site 04 - Kaiser Permanente Pediatric Clinic, 610 Walnut Street, Room 110, Redwood City

94589

Site 07 - Kaiser Permanente Pediatric Clinic 975 Sereno Drive; 1st Floor MOB Pediatric Station 1, Vallejo

94596

Site 02 - Kaiser Permanente Pediatric Clinic, 1425 S. Main Street; MOB2, 4th Floor; Station 2, Walnut Creek

94618

Site 34 - Children's Hospital and Research Center Oakland (CHRCO), Infectious Diseases Department, 747 52nd Street, Oakland

94801

Site 37 - Kaiser Permanente Pediatric Clinic 901 Nevin Ave. Room 1E24, Richmond

95403

Site 50 - Kaiser Permanente Pediatric Clinic 3925 Old Redwood Hwy, Santa Rosa

95661

Site 09 - Kaiser Permanente Pediatric Clinic 1840 Sierra Gardens Vaccine Studies, Roseville

95815

Site 03 - Kaiser Permanente Pediatric Clinic, Point West Medical Offices, 1650 Response Road, Sacramento

95817

Site 48 - Pediatric Infectious Diseases Admin 2516 Stockton Blvd.; Ticon II, Sacramento

95823

Site 10 - Kaiser Permanente Pediatric Clinic 6600 Bruceville Road Pediatric Station C, Sacramento

97030

Site 31 - Calcagno Research and Development 24850 SE Stark Street Suite 150, Gresham

98105

Site 55 - Children's Hosp. & Regional Med Ctr 4800 Sand Point Way NE; MS 5441, Seattle

99202

Site 06 - Rockwood Clinic, P.S. 400 East Fifth Avenue, Spokane

99218

Site 46 - Rockwood Clinic North 9001 N. Country Homes Blvd, Spokane

06360

Site 60 - Norwich Pediatric Group, PC 92 New London Turnpike, Norwich

02724

Site 39 - Pediatric Associates of Fall River, 829 S. Main Street, Fall River

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY

NCT00626327 - Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers | Biotech Hunter | Biotech Hunter