Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

7,744

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

March 31, 2011

Study Completion Date

November 30, 2011

Conditions
MeningitisMeningococcal Infection
Interventions
BIOLOGICAL

MenACWY-CRM197

Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.

BIOLOGICAL

DTaP (Diptheria, Tetanus, Pertussis) Vaccine

Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.

BIOLOGICAL

Hib (Haemophilus influenza b) Vaccine

Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.

BIOLOGICAL

IPV (Inactivated Polio Vaccine) Vaccine

Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.

BIOLOGICAL

Pneumococcal conjugate Vaccine

Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.

BIOLOGICAL

MMR (Measles, Mumps, and Rubella) Vaccine

One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.

BIOLOGICAL

Varicella Vaccine

One vaccination of Varicella vaccine was administered at 12 months of age.

BIOLOGICAL

Hepatitis A Virus

One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.

Trial Locations (153)

100

301 Department of Pediatrics, National Taiwan University Hospital, 15F,Children's Hospital, No. 8 Chung Shan S. Rd,, Taipei

104

302 Department of Pediatrics, Mackay Memorial Hospital No. 92, Sec. 2, ChangShan Road,, Taipei

11219

173 Maimonides Medical Center 948 48th Street 1st Floor, Brooklyn

11501

16 Winthrop University Hospital Department of Pediatrics 120 Mineola Blvd Suite 210, Mineola

13088

70 Summer Pediatrics 4811 Buckley Road, Liverpool

13210

77 SUNY Upstate Medical University 750 East Adams Street Suite 5400, Syracuse

15217

110 Pediatric Alliance Southwestern - Squirrel Hill 4070 Beechwood Blvd, Pittsburgh

15236

112 Pediatric Alliance, Southwestern 850 Clairton Blvd, Pittsburgh

15237

118 Pediatric Alliance, PC Arcadia Division 9000 Perry Highway Suite 120, Pittsburgh

15241

5 Primary Physicians Research, Inc 1580 McLaughlin Run Road, Pittsburgh

16125

109 UPMC/Community Medicine Inc. 90 Shenango Street, Greenville

16505

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

18960

49 Pennridge Pediatric Associates 711 Lawn Avenue, Sellersville

19438

107 Pennridge Pediatric Associates 270 Main Street, Harleysville

22180

93 Advanced Pediatrics 100 East Street SE Suite 301, Vienna

22902

85 Pediatric Research of Charlottesville, LLC 1011 East Jefferson St. Suite 3, Charlottesville

23113

158 Huguenot Pediatrics, PC 1407 Huguenot Rd., Midlothian

23219

46 Virginia Commonwealth University 1001 East Marshall Street P008, Richmond

27103

73 Piedmont Medical Research Assoc 1901 S Hawthorne Rd Ste 306, Winston-Salem

27511

56 Cary Pediatrics 1001 Crescent Green Dr., Cary

27609

48 Capitol Pediatrics and Adolescent Center 3801 Computer Drive Suite 200, Raleigh

27612

91 Triangle Medical Research 5816 Creedmoor Rd. Suite 104, Raleigh

27704

103 Durham Pediatrics 2609 North Duke Street, Suite 1000, Durham

104 Regional Pediatrics 4022 Freedom Lake Drive, Durham

13 Duke Health Center 4020 N. Roxboro Road, Durham

29406

41 Palmetto Pediatrics, PA Pediatrics 2781 Tricom Street, Charleston

30062

11 Pediatrics and Adolescent Medicine, PA 2155 Post Oak Tritt Road Suite 100, Marietta

30189

101 Pediatrics and Adolescent Medicine, PA 120 Stonebridge Parkway, Suite 410, Woodstock

30721

162 North Georgia Clinical Research Center 1575 Chattanooga Avenue Suite 1, Dalton

32746

99 Altamonte Pediatric Associates 101 N Country Club Rd., Lake Mary

32806

60 Orlando Health Pediatric Faculty Practice 32 West Sturtevant St, MP-141, Orlando

33410

34 Pediatric Partners Pediatrics 3401 PGA Blvd Ste 300, Palm Beach Gardens

34231

88 Physician Care Clinical Research 1918 Robinhood Street, Sarasota

35205

6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615, Birmingham

36305

43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd, Dothan

37043

90 Premier Medical Group Alpha Clinical Research 279 Clear Sky Court, Ste C Clarksville

37087

165 Focus Research Group 201 Signature Place Suite C, Lebanon

37215

52 Heritage Medical Associates 2325 Crestmoor Road, Nashville

37660

71 Holston Medical Group 105 W. Stone Dr. Suite 2A, Kingsport

72 Holston Medical Group 2033 Meadowview Lane, Kingsport

40004

51 Kentucky Pediatric/Adult Research 201 S. 5th Street, Bardstown

40069

108 Physicians to Children and Adolescents 102 West Depot Street, Springfield

40202

106 University Child Health Specialists 230 East Broadway, Louisville

15 University of Louisville 571 South Floyd Suite 321 L, Ouisville

40291

24 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite 2, Louisville

76 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite2, Louisville

40503

84 Michael W. Simon M.D. 185 Pasadena Drive Suite 220, Lexington

44121

36 Dr. Senders and Associates, Pediatrics 2054 South Green Road, Cleveland

44203

120 Akron Children's Hospital Pediatrics 62 Conservatory Drive, #A, Barberton

44308

97 Children's Hospital Medical Center of Akron One Perkins Square, Akron

44505

28 Pediatric Associates of Youngstown 4308 Belmont Avenue, Youngstown

44514

100 Pediatric Associates of Youngstown 727 East Western Reserve Road, Youngstown

45014

37 Pediatric Associates of Fairfield, Inc. 5900 Boymel Drive, Fairfield

45406

79 Dayton Clinical Research 1100 Salem Ave, Dayton

45420

102 Ohio Pediatrics, INC 1775 Delco Park Drive, Kettering

49120

168 Southwestern Medical Clinic 2002 South 11th Street, Niles

49127

26 Southwestern Medical Clinic 5515 Cleveland Avenue Suite 1, Stevensville

55108

89 Aspen Medical Group 1020 Bandana Blvd West Ste 214, Saint Paul

58103

87 Innovis Health 1702 South University Drive Suite 1, Fargo

60115

Northern Illinois Research Associates 625 E. Bethany Ste. 3, DeKalb

63044

80 Craig A. Spiegel, M.D 12255 DePaul Drive Sutie 380, Bridgeton

66614

178 Pediatric Care 6725 Southwest Twenty-Ninth Street, Topeka

67005

95 Heartland Research Associates 510 West Radio Lane, Arkansas City

67114

92 Heartland Research Associates LLC 700 Medical Center Dr. Suite 210, Newton

71105

86 Willis-Knighton Physician Network 7847 Youree Drive, Shreveport

72019

55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200, Benton

72205

170 Little Rock Children's Clinic P.A. 9600 Lile Dr., Ste 360, Little Rock

3 Arkansas Pediatric Clinic 500 S. University Suite 200, Little Rock

72401

14 The Children's Clinic of Jonesboro 800 S. Church Suite 400, Jonesboro

72703

21 Northwest Arkansas Pediatric Clinic 3383 N. MANA Court Suite 101, Fayetteville

72903

30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100, Fort Smith

74127

25 Oklahoma State University-CHS C/O Pediatrics 635 West 11th Street, Tulsa

76107

19 University of North Texas Health Science Center 3500 Camp Bowie Blvd, Fort Worth

77055

96 West Houston Clinical Research Service 2026 Wirt Road, Houston

77375

47 Dynamed Clinical Research 13406 Medical Complex Dr Suite 200, Tomball

78205

50 San Antonio Metropolitan Health District 332 West Commerce Room 307, San Antonio

78229

31 Southwest Children's Research Associates, P. A. 5282 Medical Drive Suite 311, San Antonio

79124

64 Amarillo Childrens Clinical Research #17 Care Circle, Amarillo

80229

54 1st International Research Centers 10370 Steeke Street, Thornton

84010

75 Pediatric Care 1596 S. 500 W., 1st Floor, Bountiful

84041

115 Wee Care(Layton) 1580 West Antelope Drive, Layton

116 Wee Care(Kaysville) 934 South Main Street, Suite 8, Layton

84067

117 Wee Care(Roy) 5991 South 3500 West, Suite 100, Roy

84075

44 Wee Care Pediatrics (Syracuse) 1792 West 1700 South Suite 102, Syracuse

84088

Jordan Ridge Kids & Teens 8822 S. Redwood Road Suite S103, West Jordan

84095

151 Family First Pediatrics c/o Pharmaceutical Research Organization 1268 W. South Jordan Parkway Suite 201, South Jordan

84107

181 Jean Brown Research 164 East 5900 South Suite A-112, Murray

84109

66 J. Lewis Research Inc. 2295 Foothill Drive, Salt Lake City

84121

61 Foothill Family Clinic South 6360 South 300 East Suite 100, Salt Lake City

84604

74 Utah Valley Pediatrics North University 7407 North Cedar St., Provo

84790

82 Dixie Pediatrics 1240 E 100 S STE 14 St., George

85741

81 Cholla Pediatrics 2167 West Orange Grove Road, Tuscon

89104

69 Clinical Research Center of Nevada 1012 East Sahara Avenue, Las Vegas

90015

94 Health Care Partners Medical Group 1025 W. Olympic Blvd., Los Angeles

90502

20 White Memorial Pediatric Medical Group UCLA Center for Vaccine Research 1124 West Carson Street Liu Research Building (Room 132), Torrance

90503

152 Health Care Partners Medical Group 3565 Del Amo Blvd Research Dept., Torrance

90620

179 Associated Pharmaceutical Research Center, Inc 8615 Knott Avenue Suite 5, Buena Park

90723

12 Center For Clinical Trials, LLC. 16660 Paramount Blvd Suite 301, Paramount

90807

153 Health Care Partners Medical Group Health Care Partners Medical Group 4401 Atlantic Ave., Long Beach

91306

160 San Fernando Valley Research Associates, Inc. 7111 Winnetka Ave. #14, Canoga Park

91744

129 Citrus Vally Family Practice 1400 Hacienda Blvd, La Puente

91790

40 Center for Clinical Trials of San Gabriel 1300 S Sunset Avenue Suite 101, West Covina

92354

114 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120, Loma Linda

59 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120, Loma Linda

92868

42 Children's Hospital of Orange County 455 S. Main Street, Orange

93618

157 Universal Biopharma Research Institute Inc./Alta Family Health Clinic 888 N. Alta Ave., Dinuba

93637

67 Madera Family Medical Group 1111 West 4th Street, Madera

93710

68 Sierra Medical Research 5150 N. Sixth, Suite 156, Fresno

94115

123 Kaiser Permanente (San Francisco) 2200 O'Farrell Street 6th floor room 636, San Francisco

94588

122 Kaiser Permanente (Pleasanton) 7601 Stoneridge Drive, MOB North 2nd Floor, Pleasanton

94611

121 Kaiser Permanente (Oakland) 3505 Broadway 6th floor, Oakland

63 Kaiser Permanente Vaccine Study Center One Kaiser Plaza 16th Floor, Oakland

95127

166 Buena Salud Pediatrics 2880 Story Road, San Jose

95817

57 UC Davis Medical Center 2516 Stockton Blvd Ticon II, Sacramento

96797

131 Kaiser Permanente Waipio 1st Floor 94-1480 Moaniani Street, Waipahu

96819

132 Kaiser Permanente Pediatric - Mapunapuna 2828 Paa Street, 2nd Floor, Honolulu

97006

83 The Portland Clinic LLP 15950 SW Millikan Lane Research Dept., Beaverton

97030

7 Cyn3rgy Research 24850 SE Stark Street Suite 180, Gresham

98664

124 The Vancouver Clinic/NE 87th Avenue 700 NE 87th Avenue, Vancouver

98684

125 The Vancouver Clinic/Columbia Tech Center 501 SE 172th Avenue, Vancouver

98686

167 The Vancouver Clinic/Salmon Creek 2525 NE 139th Street, Vancouver

98801

163 Wenatchee Valley Medical Center Clinical Research Department 820 North Chelan Avenue, Wenatchee

99202

2 Rockwood Clinical Research Center 400 East Fifth Avenue, Spokane

99218

38 Rockwood Clinic, P.S. 9001 N. Country Homes Blvd., Spokane

90241-4982

1 Premier Health Research Center, LLC 11525 Brookshire Ave Suite 400, Downey

06360

29 Norwich Pediatric Group 92 New London Turnpike, Norwich

02130

22 Roslindale Pediatric Assoc, P.C 1153 Centre St Suite 31, Boston

02724

23 Pediatric Associates of Fall River 829 South Main Street, Fall River

01845

126 North Andover Pediatrics Associates 800 Turnpike Street, North Andover

01801

9 Woburn Pediatric Associates 7 Alfred Street Baldwin Park II, Woburn

45424-3200

4 Ohio Pediatrics, INC 7371 Brandt Pike Suite C, Huber Heights

77555-0351

175 Sealy Center for Vaccine Development, Clinical Trials 301 University Blvd. Children's Hospital Room 3.270F L#20412, Galveston

Unknown

304 Department of Pediatrics, Chang Gung Children's Hospital 12F, L Building, #5, Fu-Shin St., Kweishan, Taoyuan 333

303 Department of Pediatrics, Taiwan Adventist Hospital 424, Sec 2, Pa-Te Road,, Taipei

401 Clínica Pediátrica Calle 20 Ave 0 y 2 Costado Oeste del Hospital Nacional de Niños - segundo piso,, San José

402 Centro Integral Medico 25 m Oeste e la Junta de Protección Social,, San José

404 Instituto de Atención Pediátrica (IAP) Del Restaurante La Bastilla, 50m Sur, Paseo Colón, San José

403 Centro Médico San Vicente 125m Este de la entrada Principal de Emergencia del Hospital, San Vicente de Paul, Heredia

507 Clínica Médica Privada Edificio Multimédica, 2 calle 25-19 Zona 15, Vista Hermosa I

508 Unidad de Crecimiento y Desarrollo, Clínica del Niño Sano, Hospital Roosevelt 6ª Avenida 3-10 Zona 11, Ingreso Principal Hospital Roosevelt, Guatemala City

502 Clínica Privada 6a Avenida 3-22 Zona 10, Centro Médico II, Ofic. 601, Guatemala City

503 Clínica para Niños 6a Avenida 6-63 Zona 10, Edificio Sixtino, Oficina 305, Tercer Nivel,, Guatemala City

506 Health Center 4ª Avenida 16-72 Zona 10,, Guatemala City

504 Clínica Periférica El Amparo II, 38 Calle 31-89, Zona 7 Colonia El Amparo II,, Guatemala City

601 Hospital Materno Infantil José Domingo De Obaldía, Centro para la Investigación y Desarrollo de Estudios Clínicos Vía Panamericana, San Pablo viejo, David,, Chiriquí

602 Centro Pediátrico América, Consultorio América Segundo Piso Consultorio No. 223, Vía España, Carrasquilla, Frente al Hospital de Especialidades Pediátricas, Panama City

603 Policentro Luis H. Moreno, Parque Lefevre, Via Cincuentenario

704 Hospital Nacional Docente Madre Niño San Bartolomé Av. Alfonso Ugarte 825,, Lima Cercado

701 Instituto de Investigación Nutricional - Anexo Huáscar, SJL Manzana 122, Lote 21, Grupo 15, Huascar, San Juan de Lurigancho

703 Hospital María Auxiliadora Av. Miguel Iglesias 968, San Juan de Miraflores,, Lima

705 Hospital Nacional Cayetano Heredia Av. Honorio Delgado No. 262, Urbanización Ingeniería, San Martín de Porres, Lima

708 Hospital Nacional Guillermo Almenara Irigoyen Av. Grau No. 800, La Victoria, Lima 13, Lima

CP 01011

501 Hospital Infantil de Infectología y Rehabilitación 9ª. Avenida 7-01 Zona 11 Colonia Roosevelt,, Guatemala City

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Novartis

INDUSTRY