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

A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants

Study Overview

• Status: Completed
• Conditions: Meningitis; Meningococcal Infection
• Intervention / Treatment: Biological: MenACWY-CRM197; Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine; Biological: Hib (Haemophilus influenza b) Vaccine; Biological: IPV (Inactivated Polio Vaccine) Vaccine; Biological: Pneumococcal conjugate Vaccine; Biological: MMR (Measles, Mumps, and Rubella) Vaccine; Biological: Varicella Vaccine; Biological: Hepatitis A Virus

• Study Type: Interventional
• Enrollment (Actual): 7744
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Taiwan
    • Kweishan, Taoyuan 333, Taiwan, China
      • 304 Department of Pediatrics, Chang Gung Children's Hospital 12F, L Building, #5, Fu-Shin St.
    • Taipei, Taiwan, China, 100
      • 301 Department of Pediatrics, National Taiwan University Hospital, 15F,Children's Hospital, No. 8 Chung Shan S. Rd,
    • Taipei, Taiwan, China, 104
      • 302 Department of Pediatrics, Mackay Memorial Hospital No. 92, Sec. 2, ChangShan Road,
    • Taipei, Taiwan, China
      • 303 Department of Pediatrics, Taiwan Adventist Hospital 424, Sec 2, Pa-Te Road,
• Costa Rica
  • San José, Costa Rica
    • 401 Clínica Pediátrica Calle 20 Ave 0 y 2 Costado Oeste del Hospital Nacional de Niños - segundo piso,
  • San José, Costa Rica
    • 402 Centro Integral Medico 25 m Oeste e la Junta de Protección Social,
  • San José, Costa Rica
    • 404 Instituto de Atención Pediátrica (IAP) Del Restaurante La Bastilla, 50m Sur, Paseo Colón
  • San Vicente de Paul, Heredia, Costa Rica
    • 403 Centro Médico San Vicente 125m Este de la entrada Principal de Emergencia del Hospital
• Guatemala
  • Guatemala City,, Guatemala, CP 01011
    • 501 Hospital Infantil de Infectología y Rehabilitación 9ª. Avenida 7-01 Zona 11 Colonia Roosevelt,
  • Guatemala CP 01015
    • Vista Hermosa I, Guatemala CP 01015, Guatemala
      • 507 Clínica Médica Privada Edificio Multimédica, 2 calle 25-19 Zona 15
  • Guatemala CP. 01011
    • Guatemala City, Guatemala CP. 01011, Guatemala
      • 508 Unidad de Crecimiento y Desarrollo, Clínica del Niño Sano, Hospital Roosevelt 6ª Avenida 3-10 Zona 11, Ingreso Principal Hospital Roosevelt
  • Guatemala CP01010
    • Guatemala City, Guatemala CP01010, Guatemala
      • 503 Clínica para Niños 6a Avenida 6-63 Zona 10, Edificio Sixtino, Oficina 305, Tercer Nivel,
    • Guatemala City, Guatemala CP01010, Guatemala
      • 506 Health Center 4ª Avenida 16-72 Zona 10,
    • Guatemala City,, Guatemala CP01010, Guatemala
      • 502 Clínica Privada 6a Avenida 3-22 Zona 10, Centro Médico II, Ofic. 601
  • Guatemala. CP 01007
    • Guatemala City, Guatemala. CP 01007, Guatemala
      • 504 Clínica Periférica El Amparo II, 38 Calle 31-89, Zona 7 Colonia El Amparo II,
• Panama
  • Chiriquí, Panama
    • 601 Hospital Materno Infantil José Domingo De Obaldía, Centro para la Investigación y Desarrollo de Estudios Clínicos Vía Panamericana, San Pablo viejo, David,
  • Ciudad de Panamá, Panama
    • 602 Centro Pediátrico América, Consultorio América Segundo Piso Consultorio No. 223, Vía España, Carrasquilla, Frente al Hospital de Especialidades Pediátricas
  • Via Cincuentenario, Panama
    • 603 Policentro Luis H. Moreno, Parque Lefevre
• Peru
  • Lima, Peru
    • 708 Hospital Nacional Guillermo Almenara Irigoyen Av. Grau No. 800, La Victoria, Lima 13
  • Lima 29, Peru
    • 703 Hospital María Auxiliadora Av. Miguel Iglesias 968, San Juan de Miraflores,
  • Lima 31, Peru
    • 705 Hospital Nacional Cayetano Heredia Av. Honorio Delgado No. 262, Urbanización Ingeniería, San Martín de Porres
  • Lima 01
    • Cercado de Lima, Lima 01, Peru
      • 704 Hospital Nacional Docente Madre Niño San Bartolomé Av. Alfonso Ugarte 825,
  • Lima 36
    • Huascar, San Juan de Lurigancho, Lima 36, Peru
      • 701 Instituto de Investigación Nutricional - Anexo Huáscar, SJL Manzana 122, Lote 21, Grupo 15
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • 6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615
    • Dothan, Alabama, United States, 36305
      • 43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd
  • Arizona
    • Tuscon, Arizona, United States, 85741
      • 81 Cholla Pediatrics 2167 West Orange Grove Road
  • Arkansas
    • Benton, Arkansas, United States, 72019
      • 55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200
    • Fayetteville, Arkansas, United States, 72703
      • 21 Northwest Arkansas Pediatric Clinic 3383 N. MANA Court Suite 101
    • Fort Smith, Arkansas, United States, 72903
      • 30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100
    • Jonesboro, Arkansas, United States, 72401
      • 14 The Children's Clinic of Jonesboro 800 S. Church Suite 400
    • Little Rock, Arkansas, United States, 72205
      • 170 Little Rock Children's Clinic P.A. 9600 Lile Dr., Ste 360
    • Little Rock, Arkansas, United States, 72205
      • 3 Arkansas Pediatric Clinic 500 S. University Suite 200
  • California
    • Buena Park, California, United States, 90620
      • 179 Associated Pharmaceutical Research Center, Inc 8615 Knott Avenue Suite 5
    • Canoga Park, California, United States, 91306
      • 160 San Fernando Valley Research Associates, Inc. 7111 Winnetka Ave. #14
    • Dinuba, California, United States, 93618
      • 157 Universal Biopharma Research Institute Inc./Alta Family Health Clinic 888 N. Alta Ave.
    • Downey, California, United States, 90241-4982
      • 1 Premier Health Research Center, LLC 11525 Brookshire Ave Suite 400
    • Fresno, California, United States, 93710
      • 68 Sierra Medical Research 5150 N. Sixth, Suite 156
    • La Puente, California, United States, 91744
      • 129 Citrus Vally Family Practice 1400 Hacienda Blvd
    • Loma Linda, California, United States, 92354
      • 114 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120
    • Loma Linda, California, United States, 92354
      • 59 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120
    • Long Beach, California, United States, 90807
      • 153 Health Care Partners Medical Group Health Care Partners Medical Group 4401 Atlantic Ave.
    • Los Angeles, California, United States, 90015
      • 94 Health Care Partners Medical Group 1025 W. Olympic Blvd.
    • Madera, California, United States, 93637
      • 67 Madera Family Medical Group 1111 West 4th Street
    • Oakland, California, United States, 94611
      • 121 Kaiser Permanente (Oakland) 3505 Broadway 6th floor
    • Oakland, California, United States, 94611
      • 63 Kaiser Permanente Vaccine Study Center One Kaiser Plaza 16th Floor
    • Orange, California, United States, 92868
      • 42 Children's Hospital of Orange County 455 S. Main Street
    • Paramount, California, United States, 90723
      • 12 Center For Clinical Trials, LLC. 16660 Paramount Blvd Suite 301
    • Pleasanton, California, United States, 94588
      • 122 Kaiser Permanente (Pleasanton) 7601 Stoneridge Drive, MOB North 2nd Floor
    • Sacramento, California, United States, 95817
      • 57 UC Davis Medical Center 2516 Stockton Blvd Ticon II
    • San Francisco, California, United States, 94115
      • 123 Kaiser Permanente (San Francisco) 2200 O'Farrell Street 6th floor room 636
    • San Jose, California, United States, 95127
      • 166 Buena Salud Pediatrics 2880 Story Road
    • Torrance, California, United States, 90502
      • 20 White Memorial Pediatric Medical Group UCLA Center for Vaccine Research 1124 West Carson Street Liu Research Building (Room 132)
    • Torrance, California, United States, 90503
      • 152 Health Care Partners Medical Group 3565 Del Amo Blvd Research Dept.
    • West Covina, California, United States, 91790
      • 40 Center for Clinical Trials of San Gabriel 1300 S Sunset Avenue Suite 101
  • Colorado
    • Thornton, Colorado, United States, 80229
      • 54 1st International Research Centers 10370 Steeke Street
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • 29 Norwich Pediatric Group 92 New London Turnpike
  • Florida
    • Lake Mary, Florida, United States, 32746
      • 99 Altamonte Pediatric Associates 101 N Country Club Rd.
    • Orlando, Florida, United States, 32806
      • 60 Orlando Health Pediatric Faculty Practice 32 West Sturtevant St, MP-141
    • Palm Beach Gardens, Florida, United States, 33410
      • 34 Pediatric Partners Pediatrics 3401 PGA Blvd Ste 300
    • Sarasota, Florida, United States, 34231
      • 88 Physician Care Clinical Research 1918 Robinhood Street
  • Georgia
    • Dalton, Georgia, United States, 30721
      • 162 North Georgia Clinical Research Center 1575 Chattanooga Avenue Suite 1
    • Marietta, Georgia, United States, 30062
      • 11 Pediatrics and Adolescent Medicine, PA 2155 Post Oak Tritt Road Suite 100
    • Woodstock, Georgia, United States, 30189
      • 101 Pediatrics and Adolescent Medicine, PA 120 Stonebridge Parkway, Suite 410
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • 132 Kaiser Permanente Pediatric - Mapunapuna 2828 Paa Street, 2nd Floor
    • Waipahu, Hawaii, United States, 96797
      • 131 Kaiser Permanente Waipio 1st Floor 94-1480 Moaniani Street
  • Illinois
    • Dekalb, Illinois, United States, 60115
      • Northern Illinois Research Associates 625 E. Bethany Ste. 3
  • Kansas
    • Arkansas City, Kansas, United States, 67005
      • 95 Heartland Research Associates 510 West Radio Lane
    • Newton, Kansas, United States, 67114
      • 92 Heartland Research Associates LLC 700 Medical Center Dr. Suite 210
    • Topeka, Kansas, United States, 66614
      • 178 Pediatric Care 6725 Southwest Twenty-Ninth Street
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • 51 Kentucky Pediatric/Adult Research 201 S. 5th Street
    • Lexington, Kentucky, United States, 40503
      • 84 Michael W. Simon M.D. 185 Pasadena Drive Suite 220
    • Louisville, Kentucky, United States, 40202
      • 106 University Child Health Specialists 230 East Broadway
    • Louisville, Kentucky, United States, 40291
      • 24 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite 2
    • Louisville, Kentucky, United States, 40291
      • 76 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite2
    • Ouisville, Kentucky, United States, 40202
      • 15 University of Louisville 571 South Floyd Suite 321 L
    • Springfield, Kentucky, United States, 40069
      • 108 Physicians to Children and Adolescents 102 West Depot Street
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • 86 Willis-Knighton Physician Network 7847 Youree Drive
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • 22 Roslindale Pediatric Assoc, P.C 1153 Centre St Suite 31
    • Fall River, Massachusetts, United States, 02724
      • 23 Pediatric Associates of Fall River 829 South Main Street
    • North Andover, Massachusetts, United States, 01845
      • 126 North Andover Pediatrics Associates 800 Turnpike Street
    • Woburn, Massachusetts, United States, 01801
      • 9 Woburn Pediatric Associates 7 Alfred Street Baldwin Park II
  • Michigan
    • Niles, Michigan, United States, 49120
      • 168 Southwestern Medical Clinic 2002 South 11th Street
    • Stevensville, Michigan, United States, 49127
      • 26 Southwestern Medical Clinic 5515 Cleveland Avenue Suite 1
  • Minnesota
    • St. Paul, Minnesota, United States, 55108
      • 89 Aspen Medical Group 1020 Bandana Blvd West Ste 214
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • 80 Craig A. Spiegel, M.D 12255 DePaul Drive Sutie 380
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • 69 Clinical Research Center of Nevada 1012 East Sahara Avenue
  • New York
    • Brooklyn, New York, United States, 11219
      • 173 Maimonides Medical Center 948 48th Street 1st Floor
    • Liverpool, New York, United States, 13088
      • 70 Summer Pediatrics 4811 Buckley Road
    • Mineola, New York, United States, 11501
      • 16 Winthrop University Hospital Department of Pediatrics 120 Mineola Blvd Suite 210
    • Syracuse, New York, United States, 13210
      • 77 SUNY Upstate Medical University 750 East Adams Street Suite 5400
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • 56 Cary Pediatrics 1001 Crescent Green Dr.
    • Durham, North Carolina, United States, 27704
      • 103 Durham Pediatrics 2609 North Duke Street, Suite 1000
    • Durham, North Carolina, United States, 27704
      • 104 Regional Pediatrics 4022 Freedom Lake Drive
    • Durham, North Carolina, United States, 27704
      • 13 Duke Health Center 4020 N. Roxboro Road
    • Raleigh, North Carolina, United States, 27609
      • 48 Capitol Pediatrics and Adolescent Center 3801 Computer Drive Suite 200
    • Raleigh, North Carolina, United States, 27612
      • 91 Triangle Medical Research 5816 Creedmoor Rd. Suite 104
    • Winston-Salem, North Carolina, United States, 27103
      • 73 Piedmont Medical Research Assoc 1901 S Hawthorne Rd Ste 306
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • 87 Innovis Health 1702 South University Drive Suite 1
  • Ohio
    • Akron, Ohio, United States, 44308
      • 97 Children's Hospital Medical Center of Akron One Perkins Square
    • Barberton, Ohio, United States, 44203
      • 120 Akron Children's Hospital Pediatrics 62 Conservatory Drive, #A
    • Cleveland, Ohio, United States, 44121
      • 36 Dr. Senders and Associates, Pediatrics 2054 South Green Road
    • Dayton, Ohio, United States, 45406
      • 79 Dayton Clinical Research 1100 Salem Ave
    • Fairfield, Ohio, United States, 45014
      • 37 Pediatric Associates of Fairfield, Inc. 5900 Boymel Drive
    • Huber Heights, Ohio, United States, 45424-3200
      • 4 Ohio Pediatrics, INC 7371 Brandt Pike Suite C
    • Kettering, Ohio, United States, 45420
      • 102 Ohio Pediatrics, INC 1775 Delco Park Drive
    • Youngstown, Ohio, United States, 44505
      • 28 Pediatric Associates of Youngstown 4308 Belmont Avenue
    • Youngstown, Ohio, United States, 44514
      • 100 Pediatric Associates of Youngstown 727 East Western Reserve Road
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
      • 25 Oklahoma State University-CHS C/O Pediatrics 635 West 11th Street
  • Oregon
    • Beaverton, Oregon, United States, 97006
      • 83 The Portland Clinic LLP 15950 SW Millikan Lane Research Dept.
    • Gresham, Oregon, United States, 97030
      • 7 Cyn3rgy Research 24850 SE Stark Street Suite 180
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16505
      • 113 Children's Health Care-West 4671 West Lake Road
    • Greenville, Pennsylvania, United States, 16125
      • 109 UPMC/Community Medicine Inc. 90 Shenango Street
    • Harleysville,, Pennsylvania, United States, 19438
      • 107 Pennridge Pediatric Associates 270 Main Street
    • Pittsburgh, Pennsylvania, United States, 15217
      • 110 Pediatric Alliance Southwestern - Squirrel Hill 4070 Beechwood Blvd
    • Pittsburgh, Pennsylvania, United States, 15236
      • 112 Pediatric Alliance, Southwestern 850 Clairton Blvd
    • Pittsburgh, Pennsylvania, United States, 15237
      • 118 Pediatric Alliance, PC Arcadia Division 9000 Perry Highway Suite 120
    • Pittsburgh, Pennsylvania, United States, 15241
      • 5 Primary Physicians Research, Inc 1580 McLaughlin Run Road
    • Sellersville, Pennsylvania, United States, 18960
      • 49 Pennridge Pediatric Associates 711 Lawn Avenue
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • 41 Palmetto Pediatrics, PA Pediatrics 2781 Tricom Street
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • 71 Holston Medical Group 105 W. Stone Dr. Suite 2A
    • Kingsport, Tennessee, United States, 37660
      • 72 Holston Medical Group 2033 Meadowview Lane
    • Lebanon, Tennessee, United States, 37087
      • 165 Focus Research Group 201 Signature Place Suite C
    • Nashville, Tennessee, United States, 37215
      • 52 Heritage Medical Associates 2325 Crestmoor Road
    • Ste C Clarksville, Tennessee, United States, 37043
      • 90 Premier Medical Group Alpha Clinical Research 279 Clear Sky Court
  • Texas
    • Amarillo, Texas, United States, 79124
      • 64 Amarillo Childrens Clinical Research #17 Care Circle
    • Fort Worth, Texas, United States, 76107
      • 19 University of North Texas Health Science Center 3500 Camp Bowie Blvd
    • Galveston, Texas, United States, 77555-0351
      • 175 Sealy Center for Vaccine Development, Clinical Trials 301 University Blvd. Children's Hospital Room 3.270F L#20412
    • Houston, Texas, United States, 77055
      • 96 West Houston Clinical Research Service 2026 Wirt Road
    • San Antonio, Texas, United States, 78205
      • 50 San Antonio Metropolitan Health District 332 West Commerce Room 307
    • San Antonio, Texas, United States, 78229
      • 31 Southwest Children's Research Associates, P. A. 5282 Medical Drive Suite 311
    • Tomball, Texas, United States, 77375
      • 47 Dynamed Clinical Research 13406 Medical Complex Dr Suite 200
  • Utah
    • Bountiful, Utah, United States, 84010
      • 75 Pediatric Care 1596 S. 500 W., 1st Floor
    • George, Utah, United States, 84790
      • 82 Dixie Pediatrics 1240 E 100 S STE 14 St.
    • Layton, Utah, United States, 84041
      • 115 Wee Care(Layton) 1580 West Antelope Drive
    • Layton, Utah, United States, 84041
      • 116 Wee Care(Kaysville) 934 South Main Street, Suite 8
    • Murray, Utah, United States, 84107
      • 181 Jean Brown Research 164 East 5900 South Suite A-112
    • Provo, Utah, United States, 84604
      • 74 Utah Valley Pediatrics North University 7407 North Cedar St.
    • Roy, Utah, United States, 84067
      • 117 Wee Care(Roy) 5991 South 3500 West, Suite 100
    • Salt Lake City, Utah, United States, 84109
      • 66 J. Lewis Research Inc. 2295 Foothill Drive
    • Salt Lake City, Utah, United States, 84121
      • 61 Foothill Family Clinic South 6360 South 300 East Suite 100
    • South Jordan, Utah, United States, 84095
      • 151 Family First Pediatrics c/o Pharmaceutical Research Organization 1268 W. South Jordan Parkway Suite 201
    • Syracuse, Utah, United States, 84075
      • 44 Wee Care Pediatrics (Syracuse) 1792 West 1700 South Suite 102
    • West Jordan, Utah, United States, 84088
      • Jordan Ridge Kids & Teens 8822 S. Redwood Road Suite S103
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • 85 Pediatric Research of Charlottesville, LLC 1011 East Jefferson St. Suite 3
    • Midlothian, Virginia, United States, 23113
      • 158 Huguenot Pediatrics, PC 1407 Huguenot Rd.
    • Richmond, Virginia, United States, 23219
      • 46 Virginia Commonwealth University 1001 East Marshall Street P008
    • Vienna, Virginia, United States, 22180
      • 93 Advanced Pediatrics 100 East Street SE Suite 301
  • Washington
    • Spokane, Washington, United States, 99202
      • 2 Rockwood Clinical Research Center 400 East Fifth Avenue
    • Spokane, Washington, United States, 99218
      • 38 Rockwood Clinic, P.S. 9001 N. Country Homes Blvd.
    • Vancouver, Washington, United States, 98664
      • 124 The Vancouver Clinic/NE 87th Avenue 700 NE 87th Avenue
    • Vancouver, Washington, United States, 98684
      • 125 The Vancouver Clinic/Columbia Tech Center 501 SE 172th Avenue
    • Vancouver, Washington, United States, 98686
      • 167 The Vancouver Clinic/Salmon Creek 2525 NE 139th Street
    • Wenatchee, Washington, United States, 98801
      • 163 Wenatchee Valley Medical Center Clinical Research Department 820 North Chelan Avenue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy 2-month-old infants (aged 55 - 89 days); babies must have been born after a full-term pregnancy with an estimated gestation age ≥37 weeks and a birth weight ≥2.5 kg
• for whom a parent/legal representative has given written informed consent after the nature of the study has been explained;
• who are available for all visits scheduled in the study;
• who are in good health as determined by medical history and physical assessment.

Exclusion Criteria:

• who previously received any meningococcal vaccine or D, T, P, IPV or OPV, H influenzae type b (Hib) or Pneumococcus; prior doses of BCG (one) and/or HBV (two) are permitted
• who have a previous confirmed or suspected disease caused by N meningitidis, C diphtheriae, C tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B pertussis (history of laboratory confirmed, or clinical condition of paroxysmal cough for a period of longer than or equal to 2 weeks associated with apnea or whooping);
• who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis (serogroups A, C, W135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection at any time since birth;
• who have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
• who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (axillary temperature ≥ 38.0°C [100.4°F]) within the previous 3 days;
• who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac disease, renal failure, severe malnutrition, or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome);

• who have a known or suspected autoimmune disease or persistent impairment/alteration of immune function resulting from (for example):

  1. receipt of any immunosuppressive therapy at any time since birth
  2. receipt of immunostimulants at any time since birth
  3. receipt of any systemic corticosteroid since birth;
• who have a suspected or known HIV infection or HIV related disease;
• who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
• who have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
• who have any history of seizure;
• who with their parents/legal representatives are planning to leave the area of the study site before the end of the study period;
• who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
• who have received any investigational agents or vaccines since birth or who expect to receive an investigational agent or vaccine prior to the completion of the study.
• who are relatives of site research staff working on this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MenACWY-CRM197 + Routine Vaccines (Non-Detailed); Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - infants who only provided SAEs (Serious Adverse Events) and medically attended AEs (Adverse Events).	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.
ACTIVE_COMPARATOR: Routine Vaccines (Non-Detailed); Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Non-Detailed - subjects who only provided SAEs and medically attended AEs.	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.
EXPERIMENTAL: MenACWY-CRM197 + Routine Vaccines (Detailed); Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.	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.
ACTIVE_COMPARATOR: Routine Vaccines (Detailed); Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.	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.
EXPERIMENTAL: MenACWY-CRM197 + Routine Vaccines (All); Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.	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.
ACTIVE_COMPARATOR: Routine Vaccines (All); Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life. Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines. All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination	To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.	15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period	To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.	Day 1 (2 months of age) to 18 months of age
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination	To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.	15 minutes to Day 7
Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination	Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.	Day 1 (2 months of age) to 18 months of age

Collaborators and Investigators

• Sponsor: Novartis
• Collaborators: Novartis Vaccines

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: December 9, 2008
• First Submitted That Met QC Criteria: December 9, 2008
• First Posted (ESTIMATE): December 10, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 9, 2013
• Last Update Submitted That Met QC Criteria: May 13, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: vaccine; infants; meningitis; healthy; meningococcal
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningitis; Meningococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: V59P23