MeningitisPhase 3NCT00806195
Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
A Phase 3 study testing MenACWY-CRM197, DTaP (Diptheria, Tetanus, Pertussis) Vaccine and Hib (Haemophilus influenza b) Vaccine in people with Meningitis and Meningococcal Infection, run by Novartis at 153 sites in 6 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 55 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal Infection
- What is being tested?
- MenACWY-CRM197, DTaP (Diptheria, Tetanus, Pertussis) Vaccine and Hib (Haemophilus influenza b) Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,744 participants
- Where
- 153 sitesin 6 countries
- Study dates
- Dec 2008to Nov 2011
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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);
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- who have a known or suspected autoimmune disease or persistent impairment/alteration of immune function resulting from (for example):
- receipt of any immunosuppressive therapy at any time since birth
- receipt of immunostimulants at any time since birth
- 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.
Trial locations and contacts
153 sites in 6 countries.
153 sites in 6 countries
United States130 sites
97 Children's Hospital Medical Center of Akron One Perkins Square
Akron, Ohio, 44308
64 Amarillo Childrens Clinical Research #17 Care Circle
Amarillo, Texas, 79124
95 Heartland Research Associates 510 West Radio Lane
Arkansas City, Kansas, 67005
120 Akron Children's Hospital Pediatrics 62 Conservatory Drive, #A
Barberton, Ohio, 44203
51 Kentucky Pediatric/Adult Research 201 S. 5th Street
Bardstown, Kentucky, 40004
83 The Portland Clinic LLP 15950 SW Millikan Lane Research Dept.
Beaverton, Oregon, 97006
55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200
Benton, Arkansas, 72019
6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615
Birmingham, Alabama, 35205
22 Roslindale Pediatric Assoc, P.C 1153 Centre St Suite 31
Boston, Massachusetts, 02130
75 Pediatric Care 1596 S. 500 W., 1st Floor
Bountiful, Utah, 84010
80 Craig A. Spiegel, M.D 12255 DePaul Drive Sutie 380
Bridgeton, Missouri, 63044
173 Maimonides Medical Center 948 48th Street 1st Floor
Brooklyn, New York, 11219
179 Associated Pharmaceutical Research Center, Inc 8615 Knott Avenue Suite 5
Buena Park, California, 90620
160 San Fernando Valley Research Associates, Inc. 7111 Winnetka Ave. #14
Canoga Park, California, 91306
56 Cary Pediatrics 1001 Crescent Green Dr.
Cary, North Carolina, 27511
41 Palmetto Pediatrics, PA Pediatrics 2781 Tricom Street
Charleston, South Carolina, 29406
85 Pediatric Research of Charlottesville, LLC 1011 East Jefferson St. Suite 3
Charlottesville, Virginia, 22902
36 Dr. Senders and Associates, Pediatrics 2054 South Green Road
Cleveland, Ohio, 44121
162 North Georgia Clinical Research Center 1575 Chattanooga Avenue Suite 1
Dalton, Georgia, 30721
79 Dayton Clinical Research 1100 Salem Ave
Dayton, Ohio, 45406
Northern Illinois Research Associates 625 E. Bethany Ste. 3
DeKalb, Illinois, 60115
157 Universal Biopharma Research Institute Inc./Alta Family Health Clinic 888 N. Alta Ave.
Dinuba, California, 93618
43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd
Dothan, Alabama, 36305
1 Premier Health Research Center, LLC 11525 Brookshire Ave Suite 400
Downey, California, 90241-4982
103 Durham Pediatrics 2609 North Duke Street, Suite 1000
Durham, North Carolina, 27704
104 Regional Pediatrics 4022 Freedom Lake Drive
Durham, North Carolina, 27704
13 Duke Health Center 4020 N. Roxboro Road
Durham, North Carolina, 27704
113 Children's Health Care-West 4671 West Lake Road
Erie, Pennsylvania, 16505
37 Pediatric Associates of Fairfield, Inc. 5900 Boymel Drive
Fairfield, Ohio, 45014
23 Pediatric Associates of Fall River 829 South Main Street
Fall River, Massachusetts, 02724
87 Innovis Health 1702 South University Drive Suite 1
Fargo, North Dakota, 58103
21 Northwest Arkansas Pediatric Clinic 3383 N. MANA Court Suite 101
Fayetteville, Arkansas, 72703
30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100
Fort Smith, Arkansas, 72903
19 University of North Texas Health Science Center 3500 Camp Bowie Blvd
Fort Worth, Texas, 76107
68 Sierra Medical Research 5150 N. Sixth, Suite 156
Fresno, California, 93710
175 Sealy Center for Vaccine Development, Clinical Trials 301 University Blvd. Children's Hospital Room 3.270F L#20412
Galveston, Texas, 77555-0351
82 Dixie Pediatrics 1240 E 100 S STE 14 St.
George, Utah, 84790
109 UPMC/Community Medicine Inc. 90 Shenango Street
Greenville, Pennsylvania, 16125
7 Cyn3rgy Research 24850 SE Stark Street Suite 180
Gresham, Oregon, 97030
107 Pennridge Pediatric Associates 270 Main Street
Harleysville, Pennsylvania, 19438
132 Kaiser Permanente Pediatric - Mapunapuna 2828 Paa Street, 2nd Floor
Honolulu, Hawaii, 96819
96 West Houston Clinical Research Service 2026 Wirt Road
Houston, Texas, 77055
4 Ohio Pediatrics, INC 7371 Brandt Pike Suite C
Huber Heights, Ohio, 45424-3200
14 The Children's Clinic of Jonesboro 800 S. Church Suite 400
Jonesboro, Arkansas, 72401
102 Ohio Pediatrics, INC 1775 Delco Park Drive
Kettering, Ohio, 45420
71 Holston Medical Group 105 W. Stone Dr. Suite 2A
Kingsport, Tennessee, 37660
72 Holston Medical Group 2033 Meadowview Lane
Kingsport, Tennessee, 37660
129 Citrus Vally Family Practice 1400 Hacienda Blvd
La Puente, California, 91744
99 Altamonte Pediatric Associates 101 N Country Club Rd.
Lake Mary, Florida, 32746
69 Clinical Research Center of Nevada 1012 East Sahara Avenue
Las Vegas, Nevada, 89104
115 Wee Care(Layton) 1580 West Antelope Drive
Layton, Utah, 84041
116 Wee Care(Kaysville) 934 South Main Street, Suite 8
Layton, Utah, 84041
165 Focus Research Group 201 Signature Place Suite C
Lebanon, Tennessee, 37087
84 Michael W. Simon M.D. 185 Pasadena Drive Suite 220
Lexington, Kentucky, 40503
170 Little Rock Children's Clinic P.A. 9600 Lile Dr., Ste 360
Little Rock, Arkansas, 72205
3 Arkansas Pediatric Clinic 500 S. University Suite 200
Little Rock, Arkansas, 72205
70 Summer Pediatrics 4811 Buckley Road
Liverpool, New York, 13088
114 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120
Loma Linda, California, 92354
59 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120
Loma Linda, California, 92354
153 Health Care Partners Medical Group Health Care Partners Medical Group 4401 Atlantic Ave.
Long Beach, California, 90807
94 Health Care Partners Medical Group 1025 W. Olympic Blvd.
Los Angeles, California, 90015
106 University Child Health Specialists 230 East Broadway
Louisville, Kentucky, 40202
24 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite 2
Louisville, Kentucky, 40291
76 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite2
Louisville, Kentucky, 40291
67 Madera Family Medical Group 1111 West 4th Street
Madera, California, 93637
11 Pediatrics and Adolescent Medicine, PA 2155 Post Oak Tritt Road Suite 100
Marietta, Georgia, 30062
158 Huguenot Pediatrics, PC 1407 Huguenot Rd.
Midlothian, Virginia, 23113
16 Winthrop University Hospital Department of Pediatrics 120 Mineola Blvd Suite 210
Mineola, New York, 11501
181 Jean Brown Research 164 East 5900 South Suite A-112
Murray, Utah, 84107
52 Heritage Medical Associates 2325 Crestmoor Road
Nashville, Tennessee, 37215
92 Heartland Research Associates LLC 700 Medical Center Dr. Suite 210
Newton, Kansas, 67114
168 Southwestern Medical Clinic 2002 South 11th Street
Niles, Michigan, 49120
126 North Andover Pediatrics Associates 800 Turnpike Street
North Andover, Massachusetts, 01845
29 Norwich Pediatric Group 92 New London Turnpike
Norwich, Connecticut, 06360
121 Kaiser Permanente (Oakland) 3505 Broadway 6th floor
Oakland, California, 94611
63 Kaiser Permanente Vaccine Study Center One Kaiser Plaza 16th Floor
Oakland, California, 94611
42 Children's Hospital of Orange County 455 S. Main Street
Orange, California, 92868
60 Orlando Health Pediatric Faculty Practice 32 West Sturtevant St, MP-141
Orlando, Florida, 32806
15 University of Louisville 571 South Floyd Suite 321 L
Ouisville, Kentucky, 40202
34 Pediatric Partners Pediatrics 3401 PGA Blvd Ste 300
Palm Beach Gardens, Florida, 33410
12 Center For Clinical Trials, LLC. 16660 Paramount Blvd Suite 301
Paramount, California, 90723
110 Pediatric Alliance Southwestern - Squirrel Hill 4070 Beechwood Blvd
Pittsburgh, Pennsylvania, 15217
112 Pediatric Alliance, Southwestern 850 Clairton Blvd
Pittsburgh, Pennsylvania, 15236
118 Pediatric Alliance, PC Arcadia Division 9000 Perry Highway Suite 120
Pittsburgh, Pennsylvania, 15237
5 Primary Physicians Research, Inc 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, 15241
122 Kaiser Permanente (Pleasanton) 7601 Stoneridge Drive, MOB North 2nd Floor
Pleasanton, California, 94588
74 Utah Valley Pediatrics North University 7407 North Cedar St.
Provo, Utah, 84604
48 Capitol Pediatrics and Adolescent Center 3801 Computer Drive Suite 200
Raleigh, North Carolina, 27609
91 Triangle Medical Research 5816 Creedmoor Rd. Suite 104
Raleigh, North Carolina, 27612
46 Virginia Commonwealth University 1001 East Marshall Street P008
Richmond, Virginia, 23219
117 Wee Care(Roy) 5991 South 3500 West, Suite 100
Roy, Utah, 84067
57 UC Davis Medical Center 2516 Stockton Blvd Ticon II
Sacramento, California, 95817
89 Aspen Medical Group 1020 Bandana Blvd West Ste 214
Saint Paul, Minnesota, 55108
66 J. Lewis Research Inc. 2295 Foothill Drive
Salt Lake City, Utah, 84109
61 Foothill Family Clinic South 6360 South 300 East Suite 100
Salt Lake City, Utah, 84121
50 San Antonio Metropolitan Health District 332 West Commerce Room 307
San Antonio, Texas, 78205
31 Southwest Children's Research Associates, P. A. 5282 Medical Drive Suite 311
San Antonio, Texas, 78229
123 Kaiser Permanente (San Francisco) 2200 O'Farrell Street 6th floor room 636
San Francisco, California, 94115
166 Buena Salud Pediatrics 2880 Story Road
San Jose, California, 95127
88 Physician Care Clinical Research 1918 Robinhood Street
Sarasota, Florida, 34231
49 Pennridge Pediatric Associates 711 Lawn Avenue
Sellersville, Pennsylvania, 18960
86 Willis-Knighton Physician Network 7847 Youree Drive
Shreveport, Louisiana, 71105
151 Family First Pediatrics c/o Pharmaceutical Research Organization 1268 W. South Jordan Parkway Suite 201
South Jordan, Utah, 84095
2 Rockwood Clinical Research Center 400 East Fifth Avenue
Spokane, Washington, 99202
38 Rockwood Clinic, P.S. 9001 N. Country Homes Blvd.
Spokane, Washington, 99218
108 Physicians to Children and Adolescents 102 West Depot Street
Springfield, Kentucky, 40069
90 Premier Medical Group Alpha Clinical Research 279 Clear Sky Court
Ste C Clarksville, Tennessee, 37043
26 Southwestern Medical Clinic 5515 Cleveland Avenue Suite 1
Stevensville, Michigan, 49127
77 SUNY Upstate Medical University 750 East Adams Street Suite 5400
Syracuse, New York, 13210
44 Wee Care Pediatrics (Syracuse) 1792 West 1700 South Suite 102
Syracuse, Utah, 84075
54 1st International Research Centers 10370 Steeke Street
Thornton, Colorado, 80229
47 Dynamed Clinical Research 13406 Medical Complex Dr Suite 200
Tomball, Texas, 77375
178 Pediatric Care 6725 Southwest Twenty-Ninth Street
Topeka, Kansas, 66614
20 White Memorial Pediatric Medical Group UCLA Center for Vaccine Research 1124 West Carson Street Liu Research Building (Room 132)
Torrance, California, 90502
152 Health Care Partners Medical Group 3565 Del Amo Blvd Research Dept.
Torrance, California, 90503
25 Oklahoma State University-CHS C/O Pediatrics 635 West 11th Street
Tulsa, Oklahoma, 74127
81 Cholla Pediatrics 2167 West Orange Grove Road
Tuscon, Arizona, 85741
124 The Vancouver Clinic/NE 87th Avenue 700 NE 87th Avenue
Vancouver, Washington, 98664
125 The Vancouver Clinic/Columbia Tech Center 501 SE 172th Avenue
Vancouver, Washington, 98684
167 The Vancouver Clinic/Salmon Creek 2525 NE 139th Street
Vancouver, Washington, 98686
93 Advanced Pediatrics 100 East Street SE Suite 301
Vienna, Virginia, 22180
131 Kaiser Permanente Waipio 1st Floor 94-1480 Moaniani Street
Waipahu, Hawaii, 96797
163 Wenatchee Valley Medical Center Clinical Research Department 820 North Chelan Avenue
Wenatchee, Washington, 98801
40 Center for Clinical Trials of San Gabriel 1300 S Sunset Avenue Suite 101
West Covina, California, 91790
Jordan Ridge Kids & Teens 8822 S. Redwood Road Suite S103
West Jordan, Utah, 84088
73 Piedmont Medical Research Assoc 1901 S Hawthorne Rd Ste 306
Winston-Salem, North Carolina, 27103
9 Woburn Pediatric Associates 7 Alfred Street Baldwin Park II
Woburn, Massachusetts, 01801
101 Pediatrics and Adolescent Medicine, PA 120 Stonebridge Parkway, Suite 410
Woodstock, Georgia, 30189
28 Pediatric Associates of Youngstown 4308 Belmont Avenue
Youngstown, Ohio, 44505
100 Pediatric Associates of Youngstown 727 East Western Reserve Road
Youngstown, Ohio, 44514
Guatemala7 sites
501 Hospital Infantil de Infectología y Rehabilitación 9ª. Avenida 7-01 Zona 11 Colonia Roosevelt,
Guatemala City, Departamento de Guatemala, CP 01011
508 Unidad de Crecimiento y Desarrollo, Clínica del Niño Sano, Hospital Roosevelt 6ª Avenida 3-10 Zona 11, Ingreso Principal Hospital Roosevelt
Guatemala City, Guatemala CP. 01011
502 Clínica Privada 6a Avenida 3-22 Zona 10, Centro Médico II, Ofic. 601
Guatemala City, Guatemala Cp01010
503 Clínica para Niños 6a Avenida 6-63 Zona 10, Edificio Sixtino, Oficina 305, Tercer Nivel,
Guatemala City, Guatemala Cp01010
506 Health Center 4ª Avenida 16-72 Zona 10,
Guatemala City, Guatemala Cp01010
504 Clínica Periférica El Amparo II, 38 Calle 31-89, Zona 7 Colonia El Amparo II,
Guatemala City, Guatemala. CP 01007
507 Clínica Médica Privada Edificio Multimédica, 2 calle 25-19 Zona 15
Vista Hermosa I, Guatemala CP 01015
Peru5 sites
701 Instituto de Investigación Nutricional - Anexo Huáscar, SJL Manzana 122, Lote 21, Grupo 15
Huascar, San Juan de Lurigancho, Lima 36
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
704 Hospital Nacional Docente Madre Niño San Bartolomé Av. Alfonso Ugarte 825,
Lima Cercado, Lima 01
China4 sites
304 Department of Pediatrics, Chang Gung Children's Hospital 12F, L Building, #5, Fu-Shin St.
Kweishan, Taoyuan 333, Taiwan
301 Department of Pediatrics, National Taiwan University Hospital, 15F,Children's Hospital, No. 8 Chung Shan S. Rd,
Taipei, Taiwan, 100
302 Department of Pediatrics, Mackay Memorial Hospital No. 92, Sec. 2, ChangShan Road,
Taipei, Taiwan, 104
303 Department of Pediatrics, Taiwan Adventist Hospital 424, Sec 2, Pa-Te Road,
Taipei, Taiwan
Costa Rica4 sites
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 José, Costa Rica
403 Centro Médico San Vicente 125m Este de la entrada Principal de Emergencia del Hospital
San Vicente de Paul, Heredia, Costa Rica
Panama3 sites
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
About this study
Official title: 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
- Conditions
- Meningitis, Meningococcal Infection
- Being tested
- MenACWY-CRM197, DTaP (Diptheria, Tetanus, Pertussis) Vaccine, Hib (Haemophilus influenza b) Vaccine, IPV (Inactivated Polio Vaccine) Vaccine, Pneumococcal conjugate Vaccine
- Keywords
- vaccine, infants, healthy, meningitis, meningococcal
- Medical subject headings
- Meningitis, Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenACWY-CRM197Biological
Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.
DTaP (Diptheria, Tetanus, Pertussis) VaccineBiological
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Hib (Haemophilus influenza b) VaccineBiological
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
IPV (Inactivated Polio Vaccine) VaccineBiological
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Pneumococcal conjugate VaccineBiological
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
MMR (Measles, Mumps, and Rubella) VaccineBiological
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
Varicella VaccineBiological
One vaccination of Varicella vaccine was administered at 12 months of age.
Hepatitis A VirusBiological
One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
| Study group | Role | What they receive |
|---|---|---|
| MenACWY-CRM197 + Routine Vaccines (Non-Detailed) | Experimental | 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). Receives: 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 |
| Routine Vaccines (Non-Detailed) | Active comparator | 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. Receives: 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 |
| MenACWY-CRM197 + Routine Vaccines (Detailed) | Experimental | 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. Receives: 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 |
| Routine Vaccines (Detailed) | Active comparator | 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. Receives: 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 |
| MenACWY-CRM197 + Routine Vaccines (All) | Experimental | 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. Receives: 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 |
| Routine Vaccines (All) | Active comparator | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Day 1 (2 months of age) to 18 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,744 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806195
- Sponsor's protocol ID
- V59P23
- Status last verified
- May 2013
- First submitted
- 9 Dec 2008
- Last updated
- 9 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov