Back to results

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

Primary Purpose

Meningitis, Meningococcal Infection

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

MenACWY-CRM197

DTaP (Diptheria, Tetanus, Pertussis) Vaccine

Hib (Haemophilus influenza b) Vaccine

IPV (Inactivated Polio Vaccine) Vaccine

Pneumococcal conjugate Vaccine

MMR (Measles, Mumps, and Rubella) Vaccine

Varicella Vaccine

Hepatitis A Virus

About this trial

This is an interventional prevention trial for Meningitis focused on measuring vaccine, infants, healthy, meningitis, meningococcal

Eligibility Criteria

55 Days - 89 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615
43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd
81 Cholla Pediatrics 2167 West Orange Grove Road
55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200
21 Northwest Arkansas Pediatric Clinic 3383 N. MANA Court Suite 101
30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100
14 The Children's Clinic of Jonesboro 800 S. Church Suite 400
170 Little Rock Children's Clinic P.A. 9600 Lile Dr., Ste 360
3 Arkansas Pediatric Clinic 500 S. University Suite 200
179 Associated Pharmaceutical Research Center, Inc 8615 Knott Avenue Suite 5
160 San Fernando Valley Research Associates, Inc. 7111 Winnetka Ave. #14
157 Universal Biopharma Research Institute Inc./Alta Family Health Clinic 888 N. Alta Ave.
1 Premier Health Research Center, LLC 11525 Brookshire Ave Suite 400
68 Sierra Medical Research 5150 N. Sixth, Suite 156
129 Citrus Vally Family Practice 1400 Hacienda Blvd
114 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120
59 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120
153 Health Care Partners Medical Group Health Care Partners Medical Group 4401 Atlantic Ave.
94 Health Care Partners Medical Group 1025 W. Olympic Blvd.
67 Madera Family Medical Group 1111 West 4th Street
121 Kaiser Permanente (Oakland) 3505 Broadway 6th floor
63 Kaiser Permanente Vaccine Study Center One Kaiser Plaza 16th Floor
42 Children's Hospital of Orange County 455 S. Main Street
12 Center For Clinical Trials, LLC. 16660 Paramount Blvd Suite 301
122 Kaiser Permanente (Pleasanton) 7601 Stoneridge Drive, MOB North 2nd Floor
57 UC Davis Medical Center 2516 Stockton Blvd Ticon II
123 Kaiser Permanente (San Francisco) 2200 O'Farrell Street 6th floor room 636
166 Buena Salud Pediatrics 2880 Story Road
20 White Memorial Pediatric Medical Group UCLA Center for Vaccine Research 1124 West Carson Street Liu Research Building (Room 132)
152 Health Care Partners Medical Group 3565 Del Amo Blvd Research Dept.
40 Center for Clinical Trials of San Gabriel 1300 S Sunset Avenue Suite 101
54 1st International Research Centers 10370 Steeke Street
29 Norwich Pediatric Group 92 New London Turnpike
99 Altamonte Pediatric Associates 101 N Country Club Rd.
60 Orlando Health Pediatric Faculty Practice 32 West Sturtevant St, MP-141
34 Pediatric Partners Pediatrics 3401 PGA Blvd Ste 300
88 Physician Care Clinical Research 1918 Robinhood Street
162 North Georgia Clinical Research Center 1575 Chattanooga Avenue Suite 1
11 Pediatrics and Adolescent Medicine, PA 2155 Post Oak Tritt Road Suite 100
101 Pediatrics and Adolescent Medicine, PA 120 Stonebridge Parkway, Suite 410
132 Kaiser Permanente Pediatric - Mapunapuna 2828 Paa Street, 2nd Floor
131 Kaiser Permanente Waipio 1st Floor 94-1480 Moaniani Street
Northern Illinois Research Associates 625 E. Bethany Ste. 3
95 Heartland Research Associates 510 West Radio Lane
92 Heartland Research Associates LLC 700 Medical Center Dr. Suite 210
178 Pediatric Care 6725 Southwest Twenty-Ninth Street
51 Kentucky Pediatric/Adult Research 201 S. 5th Street
84 Michael W. Simon M.D. 185 Pasadena Drive Suite 220
106 University Child Health Specialists 230 East Broadway
24 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite 2
76 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite2
15 University of Louisville 571 South Floyd Suite 321 L
108 Physicians to Children and Adolescents 102 West Depot Street
86 Willis-Knighton Physician Network 7847 Youree Drive
22 Roslindale Pediatric Assoc, P.C 1153 Centre St Suite 31
23 Pediatric Associates of Fall River 829 South Main Street
126 North Andover Pediatrics Associates 800 Turnpike Street
9 Woburn Pediatric Associates 7 Alfred Street Baldwin Park II
168 Southwestern Medical Clinic 2002 South 11th Street
26 Southwestern Medical Clinic 5515 Cleveland Avenue Suite 1
89 Aspen Medical Group 1020 Bandana Blvd West Ste 214
80 Craig A. Spiegel, M.D 12255 DePaul Drive Sutie 380
69 Clinical Research Center of Nevada 1012 East Sahara Avenue
173 Maimonides Medical Center 948 48th Street 1st Floor
70 Summer Pediatrics 4811 Buckley Road
16 Winthrop University Hospital Department of Pediatrics 120 Mineola Blvd Suite 210
77 SUNY Upstate Medical University 750 East Adams Street Suite 5400
56 Cary Pediatrics 1001 Crescent Green Dr.
103 Durham Pediatrics 2609 North Duke Street, Suite 1000
104 Regional Pediatrics 4022 Freedom Lake Drive
13 Duke Health Center 4020 N. Roxboro Road
48 Capitol Pediatrics and Adolescent Center 3801 Computer Drive Suite 200
91 Triangle Medical Research 5816 Creedmoor Rd. Suite 104
73 Piedmont Medical Research Assoc 1901 S Hawthorne Rd Ste 306
87 Innovis Health 1702 South University Drive Suite 1
97 Children's Hospital Medical Center of Akron One Perkins Square
120 Akron Children's Hospital Pediatrics 62 Conservatory Drive, #A
36 Dr. Senders and Associates, Pediatrics 2054 South Green Road
79 Dayton Clinical Research 1100 Salem Ave
37 Pediatric Associates of Fairfield, Inc. 5900 Boymel Drive
4 Ohio Pediatrics, INC 7371 Brandt Pike Suite C
102 Ohio Pediatrics, INC 1775 Delco Park Drive
28 Pediatric Associates of Youngstown 4308 Belmont Avenue
100 Pediatric Associates of Youngstown 727 East Western Reserve Road
25 Oklahoma State University-CHS C/O Pediatrics 635 West 11th Street
83 The Portland Clinic LLP 15950 SW Millikan Lane Research Dept.
7 Cyn3rgy Research 24850 SE Stark Street Suite 180
113 Children's Health Care-West 4671 West Lake Road
109 UPMC/Community Medicine Inc. 90 Shenango Street
107 Pennridge Pediatric Associates 270 Main Street
110 Pediatric Alliance Southwestern - Squirrel Hill 4070 Beechwood Blvd
112 Pediatric Alliance, Southwestern 850 Clairton Blvd
118 Pediatric Alliance, PC Arcadia Division 9000 Perry Highway Suite 120
5 Primary Physicians Research, Inc 1580 McLaughlin Run Road
49 Pennridge Pediatric Associates 711 Lawn Avenue
41 Palmetto Pediatrics, PA Pediatrics 2781 Tricom Street
71 Holston Medical Group 105 W. Stone Dr. Suite 2A
72 Holston Medical Group 2033 Meadowview Lane
165 Focus Research Group 201 Signature Place Suite C
52 Heritage Medical Associates 2325 Crestmoor Road
90 Premier Medical Group Alpha Clinical Research 279 Clear Sky Court
64 Amarillo Childrens Clinical Research #17 Care Circle
19 University of North Texas Health Science Center 3500 Camp Bowie Blvd
175 Sealy Center for Vaccine Development, Clinical Trials 301 University Blvd. Children's Hospital Room 3.270F L#20412
96 West Houston Clinical Research Service 2026 Wirt Road
50 San Antonio Metropolitan Health District 332 West Commerce Room 307
31 Southwest Children's Research Associates, P. A. 5282 Medical Drive Suite 311
47 Dynamed Clinical Research 13406 Medical Complex Dr Suite 200
75 Pediatric Care 1596 S. 500 W., 1st Floor
82 Dixie Pediatrics 1240 E 100 S STE 14 St.
115 Wee Care(Layton) 1580 West Antelope Drive
116 Wee Care(Kaysville) 934 South Main Street, Suite 8
181 Jean Brown Research 164 East 5900 South Suite A-112
74 Utah Valley Pediatrics North University 7407 North Cedar St.
117 Wee Care(Roy) 5991 South 3500 West, Suite 100
66 J. Lewis Research Inc. 2295 Foothill Drive
61 Foothill Family Clinic South 6360 South 300 East Suite 100
151 Family First Pediatrics c/o Pharmaceutical Research Organization 1268 W. South Jordan Parkway Suite 201
44 Wee Care Pediatrics (Syracuse) 1792 West 1700 South Suite 102
Jordan Ridge Kids & Teens 8822 S. Redwood Road Suite S103
85 Pediatric Research of Charlottesville, LLC 1011 East Jefferson St. Suite 3
158 Huguenot Pediatrics, PC 1407 Huguenot Rd.
46 Virginia Commonwealth University 1001 East Marshall Street P008
93 Advanced Pediatrics 100 East Street SE Suite 301
2 Rockwood Clinical Research Center 400 East Fifth Avenue
38 Rockwood Clinic, P.S. 9001 N. Country Homes Blvd.
124 The Vancouver Clinic/NE 87th Avenue 700 NE 87th Avenue
125 The Vancouver Clinic/Columbia Tech Center 501 SE 172th Avenue
167 The Vancouver Clinic/Salmon Creek 2525 NE 139th Street
163 Wenatchee Valley Medical Center Clinical Research Department 820 North Chelan Avenue
304 Department of Pediatrics, Chang Gung Children's Hospital 12F, L Building, #5, Fu-Shin St.
301 Department of Pediatrics, National Taiwan University Hospital, 15F,Children's Hospital, No. 8 Chung Shan S. Rd,
302 Department of Pediatrics, Mackay Memorial Hospital No. 92, Sec. 2, ChangShan Road,
303 Department of Pediatrics, Taiwan Adventist Hospital 424, Sec 2, Pa-Te Road,
401 Clínica Pediátrica Calle 20 Ave 0 y 2 Costado Oeste del Hospital Nacional de Niños - segundo piso,
402 Centro Integral Medico 25 m Oeste e la Junta de Protección Social,
404 Instituto de Atención Pediátrica (IAP) Del Restaurante La Bastilla, 50m Sur, Paseo Colón
403 Centro Médico San Vicente 125m Este de la entrada Principal de Emergencia del Hospital
507 Clínica Médica Privada Edificio Multimédica, 2 calle 25-19 Zona 15
508 Unidad de Crecimiento y Desarrollo, Clínica del Niño Sano, Hospital Roosevelt 6ª Avenida 3-10 Zona 11, Ingreso Principal Hospital Roosevelt
502 Clínica Privada 6a Avenida 3-22 Zona 10, Centro Médico II, Ofic. 601
503 Clínica para Niños 6a Avenida 6-63 Zona 10, Edificio Sixtino, Oficina 305, Tercer Nivel,
506 Health Center 4ª Avenida 16-72 Zona 10,
504 Clínica Periférica El Amparo II, 38 Calle 31-89, Zona 7 Colonia El Amparo II,
501 Hospital Infantil de Infectología y Rehabilitación 9ª. Avenida 7-01 Zona 11 Colonia Roosevelt,
601 Hospital Materno Infantil José Domingo De Obaldía, Centro para la Investigación y Desarrollo de Estudios Clínicos Vía Panamericana, San Pablo viejo, David,
602 Centro Pediátrico América, Consultorio América Segundo Piso Consultorio No. 223, Vía España, Carrasquilla, Frente al Hospital de Especialidades Pediátricas
603 Policentro Luis H. Moreno, Parque Lefevre
704 Hospital Nacional Docente Madre Niño San Bartolomé Av. Alfonso Ugarte 825,
701 Instituto de Investigación Nutricional - Anexo Huáscar, SJL Manzana 122, Lote 21, Grupo 15
703 Hospital María Auxiliadora Av. Miguel Iglesias 968, San Juan de Miraflores,
705 Hospital Nacional Cayetano Heredia Av. Honorio Delgado No. 262, Urbanización Ingeniería, San Martín de Porres
708 Hospital Nacional Guillermo Almenara Irigoyen Av. Grau No. 800, La Victoria, Lima 13

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

MenACWY-CRM197 + Routine Vaccines (Non-Detailed)

Routine Vaccines (Non-Detailed)

MenACWY-CRM197 + Routine Vaccines (Detailed)

Routine Vaccines (Detailed)

MenACWY-CRM197 + Routine Vaccines (All)

Routine Vaccines (All)

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT00806195

First Posted

December 9, 2008

Last Updated

May 13, 2013

Sponsor

Novartis

Collaborators

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00806195

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

Collaborators

Novartis Vaccines

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningitis, Meningococcal Infection

Keywords

vaccine, infants, healthy, meningitis, meningococcal

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7744 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MenACWY-CRM197 + Routine Vaccines (Non-Detailed)

Arm Type

Experimental

Arm Description

Arm Title

Routine Vaccines (Non-Detailed)

Arm Type

Active Comparator

Arm Description

Arm Title

MenACWY-CRM197 + Routine Vaccines (Detailed)

Arm Type

Experimental

Arm Description

Arm Title

Routine Vaccines (Detailed)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

MenACWY-CRM197 + Routine Vaccines (All)

Arm Type

Experimental

Arm Description

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.

Arm Title

Routine Vaccines (All)

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

MenACWY-CRM197

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

DTaP (Diptheria, Tetanus, Pertussis) Vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Hib (Haemophilus influenza b) Vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

IPV (Inactivated Polio Vaccine) Vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Pneumococcal conjugate Vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

MMR (Measles, Mumps, and Rubella) Vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Varicella Vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Hepatitis A Virus

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination

Description

Time Frame

15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age

Secondary Outcome Measure Information:

Title

Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period

Description

Time Frame

Day 1 (2 months of age) to 18 months of age

Title

Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination

Description

Time Frame

15 minutes to Day 7

Title

Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination

Description

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.

Time Frame

Day 1 (2 months of age) to 18 months of age

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Days

Maximum Age & Unit of Time

89 Days

Accepts Healthy Volunteers

Eligibility Criteria

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): 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.

Facility Information:

Facility Name

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

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36305

Country

United States

Facility Name

81 Cholla Pediatrics 2167 West Orange Grove Road

City

Tuscon

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

Facility Name

55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200

City

Benton

State/Province

Arkansas

ZIP/Postal Code

72019

Country

United States

Facility Name

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

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72903

Country

United States

Facility Name

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

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

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

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

3 Arkansas Pediatric Clinic 500 S. University Suite 200

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

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

City

Buena Park

State/Province

California

ZIP/Postal Code

90620

Country

United States

Facility Name

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

City

Canoga Park

State/Province

California

ZIP/Postal Code

91306

Country

United States

Facility Name

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

City

Dinuba

State/Province

California

ZIP/Postal Code

93618

Country

United States

Facility Name

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

City

Downey

State/Province

California

ZIP/Postal Code

90241-4982

Country

United States

Facility Name

68 Sierra Medical Research 5150 N. Sixth, Suite 156

City

Fresno

State/Province

California

ZIP/Postal Code

93710

Country

United States

Facility Name

129 Citrus Vally Family Practice 1400 Hacienda Blvd

City

La Puente

State/Province

California

ZIP/Postal Code

91744

Country

United States

Facility Name

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

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

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

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

153 Health Care Partners Medical Group Health Care Partners Medical Group 4401 Atlantic Ave.

City

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

Facility Name

94 Health Care Partners Medical Group 1025 W. Olympic Blvd.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90015

Country

United States

Facility Name

67 Madera Family Medical Group 1111 West 4th Street

City

Madera

State/Province

California

ZIP/Postal Code

93637

Country

United States

Facility Name

121 Kaiser Permanente (Oakland) 3505 Broadway 6th floor

City

Oakland

State/Province

California

ZIP/Postal Code

94611

Country

United States

Facility Name

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

City

Oakland

State/Province

California

ZIP/Postal Code

94611

Country

United States

Facility Name

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

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

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

City

Paramount

State/Province

California

ZIP/Postal Code

90723

Country

United States

Facility Name

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

City

Pleasanton

State/Province

California

ZIP/Postal Code

94588

Country

United States

Facility Name

57 UC Davis Medical Center 2516 Stockton Blvd Ticon II

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

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

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

166 Buena Salud Pediatrics 2880 Story Road

City

San Jose

State/Province

California

ZIP/Postal Code

95127

Country

United States

Facility Name

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

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

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

City

Torrance

State/Province

California

ZIP/Postal Code

90503

Country

United States

Facility Name

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

City

West Covina

State/Province

California

ZIP/Postal Code

91790

Country

United States

Facility Name

54 1st International Research Centers 10370 Steeke Street

City

Thornton

State/Province

Colorado

ZIP/Postal Code

80229

Country

United States

Facility Name

29 Norwich Pediatric Group 92 New London Turnpike

City

Norwich

State/Province

Connecticut

ZIP/Postal Code

06360

Country

United States

Facility Name

99 Altamonte Pediatric Associates 101 N Country Club Rd.

City

Lake Mary

State/Province

Florida

ZIP/Postal Code

32746

Country

United States

Facility Name

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

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

34 Pediatric Partners Pediatrics 3401 PGA Blvd Ste 300

City

Palm Beach Gardens

State/Province

Florida

ZIP/Postal Code

33410

Country

United States

Facility Name

88 Physician Care Clinical Research 1918 Robinhood Street

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34231

Country

United States

Facility Name

162 North Georgia Clinical Research Center 1575 Chattanooga Avenue Suite 1

City

Dalton

State/Province

Georgia

ZIP/Postal Code

30721

Country

United States

Facility Name

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

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30062

Country

United States

Facility Name

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

City

Woodstock

State/Province

Georgia

ZIP/Postal Code

30189

Country

United States

Facility Name

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

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96819

Country

United States

Facility Name

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

City

Waipahu

State/Province

Hawaii

ZIP/Postal Code

96797

Country

United States

Facility Name

Northern Illinois Research Associates 625 E. Bethany Ste. 3

City

Dekalb

State/Province

Illinois

ZIP/Postal Code

60115

Country

United States

Facility Name

95 Heartland Research Associates 510 West Radio Lane

City

Arkansas City

State/Province

Kansas

ZIP/Postal Code

67005

Country

United States

Facility Name

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

City

Newton

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

178 Pediatric Care 6725 Southwest Twenty-Ninth Street

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66614

Country

United States

Facility Name

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

City

Bardstown

State/Province

Kentucky

ZIP/Postal Code

40004

Country

United States

Facility Name

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

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

106 University Child Health Specialists 230 East Broadway

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

24 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite 2

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40291

Country

United States

Facility Name

76 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite2

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40291

Country

United States

Facility Name

15 University of Louisville 571 South Floyd Suite 321 L

City

Ouisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

108 Physicians to Children and Adolescents 102 West Depot Street

City

Springfield

State/Province

Kentucky

ZIP/Postal Code

40069

Country

United States

Facility Name

86 Willis-Knighton Physician Network 7847 Youree Drive

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71105

Country

United States

Facility Name

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

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02130

Country

United States

Facility Name

23 Pediatric Associates of Fall River 829 South Main Street

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02724

Country

United States

Facility Name

126 North Andover Pediatrics Associates 800 Turnpike Street

City

North Andover

State/Province

Massachusetts

ZIP/Postal Code

01845

Country

United States

Facility Name

9 Woburn Pediatric Associates 7 Alfred Street Baldwin Park II

City

Woburn

State/Province

Massachusetts

ZIP/Postal Code

01801

Country

United States

Facility Name

168 Southwestern Medical Clinic 2002 South 11th Street

City

Niles

State/Province

Michigan

ZIP/Postal Code

49120

Country

United States

Facility Name

26 Southwestern Medical Clinic 5515 Cleveland Avenue Suite 1

City

Stevensville

State/Province

Michigan

ZIP/Postal Code

49127

Country

United States

Facility Name

89 Aspen Medical Group 1020 Bandana Blvd West Ste 214

City

St. Paul

State/Province

Minnesota

ZIP/Postal Code

55108

Country

United States

Facility Name

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

City

Bridgeton

State/Province

Missouri

ZIP/Postal Code

63044

Country

United States

Facility Name

69 Clinical Research Center of Nevada 1012 East Sahara Avenue

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89104

Country

United States

Facility Name

173 Maimonides Medical Center 948 48th Street 1st Floor

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11219

Country

United States

Facility Name

70 Summer Pediatrics 4811 Buckley Road

City

Liverpool

State/Province

New York

ZIP/Postal Code

13088

Country

United States

Facility Name

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

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

77 SUNY Upstate Medical University 750 East Adams Street Suite 5400

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

56 Cary Pediatrics 1001 Crescent Green Dr.

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27511

Country

United States

Facility Name

103 Durham Pediatrics 2609 North Duke Street, Suite 1000

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

104 Regional Pediatrics 4022 Freedom Lake Drive

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

13 Duke Health Center 4020 N. Roxboro Road

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

48 Capitol Pediatrics and Adolescent Center 3801 Computer Drive Suite 200

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

91 Triangle Medical Research 5816 Creedmoor Rd. Suite 104

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

73 Piedmont Medical Research Assoc 1901 S Hawthorne Rd Ste 306

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

87 Innovis Health 1702 South University Drive Suite 1

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

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

City

Akron

State/Province

Ohio

ZIP/Postal Code

44308

Country

United States

Facility Name

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

City

Barberton

State/Province

Ohio

ZIP/Postal Code

44203

Country

United States

Facility Name

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

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44121

Country

United States

Facility Name

79 Dayton Clinical Research 1100 Salem Ave

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45406

Country

United States

Facility Name

37 Pediatric Associates of Fairfield, Inc. 5900 Boymel Drive

City

Fairfield

State/Province

Ohio

ZIP/Postal Code

45014

Country

United States

Facility Name

4 Ohio Pediatrics, INC 7371 Brandt Pike Suite C

City

Huber Heights

State/Province

Ohio

ZIP/Postal Code

45424-3200

Country

United States

Facility Name

102 Ohio Pediatrics, INC 1775 Delco Park Drive

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45420

Country

United States

Facility Name

28 Pediatric Associates of Youngstown 4308 Belmont Avenue

City

Youngstown

State/Province

Ohio

ZIP/Postal Code

44505

Country

United States

Facility Name

100 Pediatric Associates of Youngstown 727 East Western Reserve Road

City

Youngstown

State/Province

Ohio

ZIP/Postal Code

44514

Country

United States

Facility Name

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

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74127

Country

United States

Facility Name

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

City

Beaverton

State/Province

Oregon

ZIP/Postal Code

97006

Country

United States

Facility Name

7 Cyn3rgy Research 24850 SE Stark Street Suite 180

City

Gresham

State/Province

Oregon

ZIP/Postal Code

97030

Country

United States

Facility Name

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

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16505

Country

United States

Facility Name

109 UPMC/Community Medicine Inc. 90 Shenango Street

City

Greenville

State/Province

Pennsylvania

ZIP/Postal Code

16125

Country

United States

Facility Name

107 Pennridge Pediatric Associates 270 Main Street

City

Harleysville,

State/Province

Pennsylvania

ZIP/Postal Code

19438

Country

United States

Facility Name

110 Pediatric Alliance Southwestern - Squirrel Hill 4070 Beechwood Blvd

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15217

Country

United States

Facility Name

112 Pediatric Alliance, Southwestern 850 Clairton Blvd

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

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

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15237

Country

United States

Facility Name

5 Primary Physicians Research, Inc 1580 McLaughlin Run Road

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

49 Pennridge Pediatric Associates 711 Lawn Avenue

City

Sellersville

State/Province

Pennsylvania

ZIP/Postal Code

18960

Country

United States

Facility Name

41 Palmetto Pediatrics, PA Pediatrics 2781 Tricom Street

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

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

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

72 Holston Medical Group 2033 Meadowview Lane

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

165 Focus Research Group 201 Signature Place Suite C

City

Lebanon

State/Province

Tennessee

ZIP/Postal Code

37087

Country

United States

Facility Name

52 Heritage Medical Associates 2325 Crestmoor Road

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

90 Premier Medical Group Alpha Clinical Research 279 Clear Sky Court

City

Ste C Clarksville

State/Province

Tennessee

ZIP/Postal Code

37043

Country

United States

Facility Name

64 Amarillo Childrens Clinical Research #17 Care Circle

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79124

Country

United States

Facility Name

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

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

Facility Name

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

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555-0351

Country

United States

Facility Name

96 West Houston Clinical Research Service 2026 Wirt Road

City

Houston

State/Province

Texas

ZIP/Postal Code

77055

Country

United States

Facility Name

50 San Antonio Metropolitan Health District 332 West Commerce Room 307

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78205

Country

United States

Facility Name

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

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

47 Dynamed Clinical Research 13406 Medical Complex Dr Suite 200

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

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

City

Bountiful

State/Province

Utah

ZIP/Postal Code

84010

Country

United States

Facility Name

82 Dixie Pediatrics 1240 E 100 S STE 14 St.

City

George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

115 Wee Care(Layton) 1580 West Antelope Drive

City

Layton

State/Province

Utah

ZIP/Postal Code

84041

Country

United States

Facility Name

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

City

Layton

State/Province

Utah

ZIP/Postal Code

84041

Country

United States

Facility Name

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

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

74 Utah Valley Pediatrics North University 7407 North Cedar St.

City

Provo

State/Province

Utah

ZIP/Postal Code

84604

Country

United States

Facility Name

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

City

Roy

State/Province

Utah

ZIP/Postal Code

84067

Country

United States

Facility Name

66 J. Lewis Research Inc. 2295 Foothill Drive

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

Country

United States

Facility Name

61 Foothill Family Clinic South 6360 South 300 East Suite 100

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84121

Country

United States

Facility Name

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

City

South Jordan

State/Province

Utah

ZIP/Postal Code

84095

Country

United States

Facility Name

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

City

Syracuse

State/Province

Utah

ZIP/Postal Code

84075

Country

United States

Facility Name

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

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

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

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22902

Country

United States

Facility Name

158 Huguenot Pediatrics, PC 1407 Huguenot Rd.

City

Midlothian

State/Province

Virginia

ZIP/Postal Code

23113

Country

United States

Facility Name

46 Virginia Commonwealth University 1001 East Marshall Street P008

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Facility Name

93 Advanced Pediatrics 100 East Street SE Suite 301

City

Vienna

State/Province

Virginia

ZIP/Postal Code

22180

Country

United States

Facility Name

2 Rockwood Clinical Research Center 400 East Fifth Avenue

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

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

City

Spokane

State/Province

Washington

ZIP/Postal Code

99218

Country

United States

Facility Name

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

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98664

Country

United States

Facility Name

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

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98684

Country

United States

Facility Name

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

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98686

Country

United States

Facility Name

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

City

Wenatchee

State/Province

Washington

ZIP/Postal Code

98801

Country

United States

Facility Name

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

City

Kweishan, Taoyuan 333

State/Province

Taiwan

Country

China

Facility Name

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

City

Taipei

State/Province

Taiwan

ZIP/Postal Code

100

Country

China

Facility Name

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

City

Taipei

State/Province

Taiwan

ZIP/Postal Code

104

Country

China

Facility Name

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

City

Taipei

State/Province

Taiwan

Country

China

Facility Name

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

City

San José

Country

Costa Rica

Facility Name

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

City

San José

Country

Costa Rica

Facility Name

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

City

San José

Country

Costa Rica

Facility Name

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

City

San Vicente de Paul, Heredia

Country

Costa Rica

Facility Name

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

City

Vista Hermosa I

State/Province

Guatemala CP 01015

Country

Guatemala

Facility Name

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

City

Guatemala City

State/Province

Guatemala CP. 01011

Country

Guatemala

Facility Name

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

City

Guatemala City,

State/Province

Guatemala CP01010

Country

Guatemala

Facility Name

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

City

Guatemala City

State/Province

Guatemala CP01010

Country

Guatemala

Facility Name

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

City

Guatemala City

State/Province

Guatemala CP01010

Country

Guatemala

Facility Name

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

City

Guatemala City

State/Province

Guatemala. CP 01007

Country

Guatemala

Facility Name

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

City

Guatemala City,

ZIP/Postal Code

CP 01011

Country

Guatemala

Facility Name

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

City

Chiriquí

Country

Panama

Facility Name

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

City

Ciudad de Panamá

Country

Panama

Facility Name

603 Policentro Luis H. Moreno, Parque Lefevre

City

Via Cincuentenario

Country

Panama

Facility Name

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

City

Cercado de Lima

State/Province

Lima 01

Country

Peru

Facility Name

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

City

Huascar, San Juan de Lurigancho

State/Province

Lima 36

Country

Peru

Facility Name

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

City

Lima 29

Country

Peru

Facility Name

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

City

Lima 31

Country

Peru

Facility Name

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

City

Lima

Country

Peru

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs