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

NCT ID: NCT00806195

Last Updated: 2013-07-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

7744 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Meningitis Meningococcal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

MenACWY-CRM197

Intervention Type BIOLOGICAL

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) Vaccine

Intervention Type BIOLOGICAL

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

Hib (Haemophilus influenza b) Vaccine

Intervention Type BIOLOGICAL

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

IPV (Inactivated Polio Vaccine) Vaccine

Intervention Type BIOLOGICAL

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

Pneumococcal conjugate Vaccine

Intervention Type BIOLOGICAL

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

MMR (Measles, Mumps, and Rubella) Vaccine

Intervention Type BIOLOGICAL

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

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.

Group Type ACTIVE_COMPARATOR

DTaP (Diptheria, Tetanus, Pertussis) Vaccine

Intervention Type BIOLOGICAL

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

Hib (Haemophilus influenza b) Vaccine

Intervention Type BIOLOGICAL

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

IPV (Inactivated Polio Vaccine) Vaccine

Intervention Type BIOLOGICAL

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

Pneumococcal conjugate Vaccine

Intervention Type BIOLOGICAL

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

MMR (Measles, Mumps, and Rubella) Vaccine

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

MenACWY-CRM197

Intervention Type BIOLOGICAL

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) Vaccine

Intervention Type BIOLOGICAL

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

Hib (Haemophilus influenza b) Vaccine

Intervention Type BIOLOGICAL

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

IPV (Inactivated Polio Vaccine) Vaccine

Intervention Type BIOLOGICAL

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

Pneumococcal conjugate Vaccine

Intervention Type BIOLOGICAL

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

MMR (Measles, Mumps, and Rubella) Vaccine

Intervention Type BIOLOGICAL

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

Varicella Vaccine

Intervention Type BIOLOGICAL

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

Hepatitis A Virus

Intervention Type BIOLOGICAL

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

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.

Group Type ACTIVE_COMPARATOR

DTaP (Diptheria, Tetanus, Pertussis) Vaccine

Intervention Type BIOLOGICAL

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

Hib (Haemophilus influenza b) Vaccine

Intervention Type BIOLOGICAL

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

IPV (Inactivated Polio Vaccine) Vaccine

Intervention Type BIOLOGICAL

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

Pneumococcal conjugate Vaccine

Intervention Type BIOLOGICAL

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

MMR (Measles, Mumps, and Rubella) Vaccine

Intervention Type BIOLOGICAL

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

Varicella Vaccine

Intervention Type BIOLOGICAL

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

Hepatitis A Virus

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

MenACWY-CRM197

Intervention Type BIOLOGICAL

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) Vaccine

Intervention Type BIOLOGICAL

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

Hib (Haemophilus influenza b) Vaccine

Intervention Type BIOLOGICAL

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

IPV (Inactivated Polio Vaccine) Vaccine

Intervention Type BIOLOGICAL

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

Pneumococcal conjugate Vaccine

Intervention Type BIOLOGICAL

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

MMR (Measles, Mumps, and Rubella) Vaccine

Intervention Type BIOLOGICAL

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

Varicella Vaccine

Intervention Type BIOLOGICAL

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

Hepatitis A Virus

Intervention Type BIOLOGICAL

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

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.

Group Type ACTIVE_COMPARATOR

DTaP (Diptheria, Tetanus, Pertussis) Vaccine

Intervention Type BIOLOGICAL

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

Hib (Haemophilus influenza b) Vaccine

Intervention Type BIOLOGICAL

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

IPV (Inactivated Polio Vaccine) Vaccine

Intervention Type BIOLOGICAL

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

Pneumococcal conjugate Vaccine

Intervention Type BIOLOGICAL

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

MMR (Measles, Mumps, and Rubella) Vaccine

Intervention Type BIOLOGICAL

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

Varicella Vaccine

Intervention Type BIOLOGICAL

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

Hepatitis A Virus

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type BIOLOGICAL

DTaP (Diptheria, Tetanus, Pertussis) Vaccine

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

Intervention Type 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.

Intervention Type BIOLOGICAL

IPV (Inactivated Polio Vaccine) Vaccine

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

Intervention Type BIOLOGICAL

Pneumococcal conjugate Vaccine

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

Intervention Type BIOLOGICAL

MMR (Measles, Mumps, and Rubella) Vaccine

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

Intervention Type BIOLOGICAL

Varicella Vaccine

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

Intervention Type BIOLOGICAL

Hepatitis A Virus

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

55 Days

Maximum Eligible Age

89 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Birmingham, Alabama, United States

Site Status

43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd

Dothan, Alabama, United States

Site Status

81 Cholla Pediatrics 2167 West Orange Grove Road

Tuscon, Arizona, United States

Site Status

55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200

Benton, Arkansas, United States

Site Status

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

Fayetteville, Arkansas, United States

Site Status

30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100

Fort Smith, Arkansas, United States

Site Status

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

Jonesboro, Arkansas, United States

Site Status

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

Little Rock, Arkansas, United States

Site Status

3 Arkansas Pediatric Clinic 500 S. University Suite 200

Little Rock, Arkansas, United States

Site Status

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

Buena Park, California, United States

Site Status

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

Canoga Park, California, United States

Site Status

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

Dinuba, California, United States

Site Status

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

Downey, California, United States

Site Status

68 Sierra Medical Research 5150 N. Sixth, Suite 156

Fresno, California, United States

Site Status

129 Citrus Vally Family Practice 1400 Hacienda Blvd

La Puente, California, United States

Site Status

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

Loma Linda, California, United States

Site Status

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

Loma Linda, California, United States

Site Status

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

Long Beach, California, United States

Site Status

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

Los Angeles, California, United States

Site Status

67 Madera Family Medical Group 1111 West 4th Street

Madera, California, United States

Site Status

121 Kaiser Permanente (Oakland) 3505 Broadway 6th floor

Oakland, California, United States

Site Status

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

Oakland, California, United States

Site Status

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

Orange, California, United States

Site Status

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

Paramount, California, United States

Site Status

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

Pleasanton, California, United States

Site Status

57 UC Davis Medical Center 2516 Stockton Blvd Ticon II

Sacramento, California, United States

Site Status

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

San Francisco, California, United States

Site Status

166 Buena Salud Pediatrics 2880 Story Road

San Jose, California, United States

Site Status

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

Torrance, California, United States

Site Status

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

Torrance, California, United States

Site Status

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

West Covina, California, United States

Site Status

54 1st International Research Centers 10370 Steeke Street

Thornton, Colorado, United States

Site Status

29 Norwich Pediatric Group 92 New London Turnpike

Norwich, Connecticut, United States

Site Status

99 Altamonte Pediatric Associates 101 N Country Club Rd.

Lake Mary, Florida, United States

Site Status

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

Orlando, Florida, United States

Site Status

34 Pediatric Partners Pediatrics 3401 PGA Blvd Ste 300

Palm Beach Gardens, Florida, United States

Site Status

88 Physician Care Clinical Research 1918 Robinhood Street

Sarasota, Florida, United States

Site Status

162 North Georgia Clinical Research Center 1575 Chattanooga Avenue Suite 1

Dalton, Georgia, United States

Site Status

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

Marietta, Georgia, United States

Site Status

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

Woodstock, Georgia, United States

Site Status

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

Honolulu, Hawaii, United States

Site Status

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

Waipahu, Hawaii, United States

Site Status

Northern Illinois Research Associates 625 E. Bethany Ste. 3

DeKalb, Illinois, United States

Site Status

95 Heartland Research Associates 510 West Radio Lane

Arkansas City, Kansas, United States

Site Status

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

Newton, Kansas, United States

Site Status

178 Pediatric Care 6725 Southwest Twenty-Ninth Street

Topeka, Kansas, United States

Site Status

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

Bardstown, Kentucky, United States

Site Status

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

Lexington, Kentucky, United States

Site Status

106 University Child Health Specialists 230 East Broadway

Louisville, Kentucky, United States

Site Status

24 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite 2

Louisville, Kentucky, United States

Site Status

76 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite2

Louisville, Kentucky, United States

Site Status

15 University of Louisville 571 South Floyd Suite 321 L

Ouisville, Kentucky, United States

Site Status

108 Physicians to Children and Adolescents 102 West Depot Street

Springfield, Kentucky, United States

Site Status

86 Willis-Knighton Physician Network 7847 Youree Drive

Shreveport, Louisiana, United States

Site Status

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

Boston, Massachusetts, United States

Site Status

23 Pediatric Associates of Fall River 829 South Main Street

Fall River, Massachusetts, United States

Site Status

126 North Andover Pediatrics Associates 800 Turnpike Street

North Andover, Massachusetts, United States

Site Status

9 Woburn Pediatric Associates 7 Alfred Street Baldwin Park II

Woburn, Massachusetts, United States

Site Status

168 Southwestern Medical Clinic 2002 South 11th Street

Niles, Michigan, United States

Site Status

26 Southwestern Medical Clinic 5515 Cleveland Avenue Suite 1

Stevensville, Michigan, United States

Site Status

89 Aspen Medical Group 1020 Bandana Blvd West Ste 214

Saint Paul, Minnesota, United States

Site Status

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

Bridgeton, Missouri, United States

Site Status

69 Clinical Research Center of Nevada 1012 East Sahara Avenue

Las Vegas, Nevada, United States

Site Status

173 Maimonides Medical Center 948 48th Street 1st Floor

Brooklyn, New York, United States

Site Status

70 Summer Pediatrics 4811 Buckley Road

Liverpool, New York, United States

Site Status

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

Mineola, New York, United States

Site Status

77 SUNY Upstate Medical University 750 East Adams Street Suite 5400

Syracuse, New York, United States

Site Status

56 Cary Pediatrics 1001 Crescent Green Dr.

Cary, North Carolina, United States

Site Status

103 Durham Pediatrics 2609 North Duke Street, Suite 1000

Durham, North Carolina, United States

Site Status

104 Regional Pediatrics 4022 Freedom Lake Drive

Durham, North Carolina, United States

Site Status

13 Duke Health Center 4020 N. Roxboro Road

Durham, North Carolina, United States

Site Status

48 Capitol Pediatrics and Adolescent Center 3801 Computer Drive Suite 200

Raleigh, North Carolina, United States

Site Status

91 Triangle Medical Research 5816 Creedmoor Rd. Suite 104

Raleigh, North Carolina, United States

Site Status

73 Piedmont Medical Research Assoc 1901 S Hawthorne Rd Ste 306

Winston-Salem, North Carolina, United States

Site Status

87 Innovis Health 1702 South University Drive Suite 1

Fargo, North Dakota, United States

Site Status

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

Akron, Ohio, United States

Site Status

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

Barberton, Ohio, United States

Site Status

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

Cleveland, Ohio, United States

Site Status

79 Dayton Clinical Research 1100 Salem Ave

Dayton, Ohio, United States

Site Status

37 Pediatric Associates of Fairfield, Inc. 5900 Boymel Drive

Fairfield, Ohio, United States

Site Status

4 Ohio Pediatrics, INC 7371 Brandt Pike Suite C

Huber Heights, Ohio, United States

Site Status

102 Ohio Pediatrics, INC 1775 Delco Park Drive

Kettering, Ohio, United States

Site Status

28 Pediatric Associates of Youngstown 4308 Belmont Avenue

Youngstown, Ohio, United States

Site Status

100 Pediatric Associates of Youngstown 727 East Western Reserve Road

Youngstown, Ohio, United States

Site Status

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

Tulsa, Oklahoma, United States

Site Status

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

Beaverton, Oregon, United States

Site Status

7 Cyn3rgy Research 24850 SE Stark Street Suite 180

Gresham, Oregon, United States

Site Status

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

Erie, Pennsylvania, United States

Site Status

109 UPMC/Community Medicine Inc. 90 Shenango Street

Greenville, Pennsylvania, United States

Site Status

107 Pennridge Pediatric Associates 270 Main Street

Harleysville, Pennsylvania, United States

Site Status

110 Pediatric Alliance Southwestern - Squirrel Hill 4070 Beechwood Blvd

Pittsburgh, Pennsylvania, United States

Site Status

112 Pediatric Alliance, Southwestern 850 Clairton Blvd

Pittsburgh, Pennsylvania, United States

Site Status

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

Pittsburgh, Pennsylvania, United States

Site Status

5 Primary Physicians Research, Inc 1580 McLaughlin Run Road

Pittsburgh, Pennsylvania, United States

Site Status

49 Pennridge Pediatric Associates 711 Lawn Avenue

Sellersville, Pennsylvania, United States

Site Status

41 Palmetto Pediatrics, PA Pediatrics 2781 Tricom Street

Charleston, South Carolina, United States

Site Status

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

Kingsport, Tennessee, United States

Site Status

72 Holston Medical Group 2033 Meadowview Lane

Kingsport, Tennessee, United States

Site Status

165 Focus Research Group 201 Signature Place Suite C

Lebanon, Tennessee, United States

Site Status

52 Heritage Medical Associates 2325 Crestmoor Road

Nashville, Tennessee, United States

Site Status

90 Premier Medical Group Alpha Clinical Research 279 Clear Sky Court

Ste C Clarksville, Tennessee, United States

Site Status

64 Amarillo Childrens Clinical Research #17 Care Circle

Amarillo, Texas, United States

Site Status

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

Fort Worth, Texas, United States

Site Status

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

Galveston, Texas, United States

Site Status

96 West Houston Clinical Research Service 2026 Wirt Road

Houston, Texas, United States

Site Status

50 San Antonio Metropolitan Health District 332 West Commerce Room 307

San Antonio, Texas, United States

Site Status

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

San Antonio, Texas, United States

Site Status

47 Dynamed Clinical Research 13406 Medical Complex Dr Suite 200

Tomball, Texas, United States

Site Status

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

Bountiful, Utah, United States

Site Status

82 Dixie Pediatrics 1240 E 100 S STE 14 St.

George, Utah, United States

Site Status

115 Wee Care(Layton) 1580 West Antelope Drive

Layton, Utah, United States

Site Status

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

Layton, Utah, United States

Site Status

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

Murray, Utah, United States

Site Status

74 Utah Valley Pediatrics North University 7407 North Cedar St.

Provo, Utah, United States

Site Status

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

Roy, Utah, United States

Site Status

66 J. Lewis Research Inc. 2295 Foothill Drive

Salt Lake City, Utah, United States

Site Status

61 Foothill Family Clinic South 6360 South 300 East Suite 100

Salt Lake City, Utah, United States

Site Status

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

South Jordan, Utah, United States

Site Status

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

Syracuse, Utah, United States

Site Status

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

West Jordan, Utah, United States

Site Status

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

Charlottesville, Virginia, United States

Site Status

158 Huguenot Pediatrics, PC 1407 Huguenot Rd.

Midlothian, Virginia, United States

Site Status

46 Virginia Commonwealth University 1001 East Marshall Street P008

Richmond, Virginia, United States

Site Status

93 Advanced Pediatrics 100 East Street SE Suite 301

Vienna, Virginia, United States

Site Status

2 Rockwood Clinical Research Center 400 East Fifth Avenue

Spokane, Washington, United States

Site Status

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

Spokane, Washington, United States

Site Status

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

Vancouver, Washington, United States

Site Status

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

Vancouver, Washington, United States

Site Status

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

Vancouver, Washington, United States

Site Status

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

Wenatchee, Washington, United States

Site Status

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

Kweishan, Taoyuan 333, Taiwan, China

Site Status

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

Taipei, Taiwan, China

Site Status

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

Taipei, Taiwan, China

Site Status

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

Taipei, Taiwan, China

Site Status

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

San José, Costa Rica, Costa Rica

Site Status

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

San José, Costa Rica, Costa Rica

Site Status

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

San José, Costa Rica, Costa Rica

Site Status

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

San Vicente de Paul, Heredia, Costa Rica, Costa Rica

Site Status

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

Guatemala City, Departamento de Guatemala, Guatemala

Site Status

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

Vista Hermosa I, Guatemala CP 01015, Guatemala

Site Status

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, Guatemala

Site Status

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

Guatemala City, Guatemala Cp01010, Guatemala

Site Status

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

Guatemala City, Guatemala Cp01010, Guatemala

Site Status

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

Guatemala City, Guatemala Cp01010, Guatemala

Site Status

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

Guatemala City, Guatemala. CP 01007, Guatemala

Site Status

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

Chiriquí, , Panama

Site Status

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

Panama City, , Panama

Site Status

603 Policentro Luis H. Moreno, Parque Lefevre

Via Cincuentenario, , Panama

Site Status

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

Lima Cercado, Lima 01, Peru

Site Status

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

Huascar, San Juan de Lurigancho, Lima 36, Peru

Site Status

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

Lima, , Peru

Site Status

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

Lima, , Peru

Site Status

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

Lima, , Peru

Site Status

Countries

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United States China Costa Rica Guatemala Panama Peru

Other Identifiers

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V59P23

Identifier Type: -

Identifier Source: org_study_id

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