Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
- Conditions
- Pneumococcal VaccinesPneumococcal Infections
- Interventions
- Biological: Prevnar 13™Biological: V114Biological: RotaTeq™Biological: Pentacel™Biological: RECOMBIVAX HB™Biological: VAQTA™Biological: MMR II™Biological: VARIVAX™Biological: HIBERIX™
- Registration Number
- NCT03893448
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1720
- Is healthy (based on a review of medical history and physical examination) in the clinical judgement of the investigator
- Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
- Has a history of invasive pneumococcal disease (IPD; positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
- Has any contraindication to the concomitant study vaccines being administered in the study.
- Had a recent febrile illness (rectal temperature ≥38.1°C [=100.5°F] or axillary temperature ≥37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study vaccine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V114 RotaTeq™ Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. V114 Pentacel™ Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. V114 RECOMBIVAX HB™ Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. V114 HIBERIX™ Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. Prevnar 13™ Prevnar 13™ Participants receive 4 total 0.5 mL IM vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. V114 V114 Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. V114 MMR II™ Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. Prevnar 13™ RECOMBIVAX HB™ Participants receive 4 total 0.5 mL IM vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. Prevnar 13™ HIBERIX™ Participants receive 4 total 0.5 mL IM vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. V114 VARIVAX™ Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. Prevnar 13™ RotaTeq™ Participants receive 4 total 0.5 mL IM vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. Prevnar 13™ MMR II™ Participants receive 4 total 0.5 mL IM vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. Prevnar 13™ VARIVAX™ Participants receive 4 total 0.5 mL IM vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. V114 VAQTA™ Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. Prevnar 13™ Pentacel™ Participants receive 4 total 0.5 mL IM vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. Prevnar 13™ VAQTA™ Participants receive 4 total 0.5 mL IM vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 One month after Vaccination 3 (Month 7) Anti-PnP serotype-specific IgG response rates for the 15 serotypes contained in V114 were measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
GMC of Anti-PnP IgG Ab One Month After Vaccination 4 One month after Vaccination 4 (Month 13 to Month 16) The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 4 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ Up to 14 days after each vaccination with either V114 or Prevnar 13™ An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of swelling, redness, pain or tenderness, and hard lump.
Percentage of Participants With Solicited Systemic AEs Up to 14 days after each vaccination with either V114 or Prevnar 13™ An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of irritability, drowsiness, appetite lost, and hives or welts.
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) From Day 1 up to 6 months after Vaccination 4 (up to 21 months) An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. Any SAEs that are at least possibly related to vaccination are summarized.
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 One month after Vaccination 3 (Month 7) The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 3 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 One month after Vaccination 3 (Month 7) Antibody responses to diphtheria toxoid, tetanus toxoid, and pertussis antigens were measured using Luminex Assay. The percentage of participants meeting specific criteria are summarized for each serotype. The serotype-specific response rate criteria are as follows: diphtheria toxoid: % ≥0.1 IU/mL; tetanus toxoid: % ≥0.1 IU/mL; pertussis toxin (PT): % ≥ 5 EU/mL; pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL; pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL; pertussis pertactin (PRN): % ≥5 EU/mL; poliovirus 1: % neutralizing antibody (NAb) ≥1:8 dilution; poliovirus 2: % NAb ≥1:8 dilution, poliovirus 3: % NAb ≥1:8 dilution; and Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL.
Hepatitis A Antibody Response Rate One Month After Vaccination 4 One month after Vaccination 4 (Month 13 to Month 16) Antibody response rates to hepatitis A were measured with hepatitis A virus enzyme immunoassay (HAV EIA). The percentage of participants with hepatitis A antigen ≥10 mIU/mL are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 One month after Vaccination 3 (Month 7) Serotype-specific anti-PnP OPA GMTs were measured with multiplex opsonophagocytic assay (MOPA). The GMTs for each serotype are summarized.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 One month after Vaccination 3 (Month 7) Serotype-specific anti-PnP OPA GMTs were measured with MOPA. The percentage of participants meeting ≥0.35 ug/mL are reported for each serotype.
Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 One month after Vaccination 4 (Month 13 to Month 16) Antibody responses to measles were measured with the bulk measles IgG enzyme immunoassay (EIA). Antibody responses to mumps were measured with enzyme-linked immunosorbent assay (ELISA). Antibody responses to rubella were measured with Bulk Rubella IgG EIA. The percentage of participants with measles antigen ≥255 mIU/ML; mumps antigen ≥10 mumps Ab units/mL; and rubella antigen ≥10 IU/mL, are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes One month after Vaccination 3 (Month 7) Serotype-specific anti-PnP IgG response rates for the 2 unique V114 serotypes were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 One month after Vaccination 3 (Month 7) Pertussis antibody GMCs were measured using Luminex Assay.
Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4 One month after Vaccination 4 (Month 13 to Month 16) Antibody responses to varicella-zoster virus were measured with glycoprotein enzyme-linked immunosorbent assay (gpELISA). The percentage of participants with VZV antigen ≥5 gpELISA units/mL are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4 One month after Vaccination 4 (Month 13 to Month 16) Serotype 3-specific anti-PnP GMC were measured with PnECL.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3 One month after Vaccination 3 (Month 7) Serotype 3-specific anti-PnP IgG response rates were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for Serotype 3.
Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4 One month after Vaccination 4 (Month 13 to Month 16) Antibody responses to Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP) were measured with ELISA. The percentage of participants with anti-HiB PRP antigen ≥0.15 ug/mL are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes One month after Vaccination 3 (Month 7) Serotype-specific anti-PnP IgG GMCs for the 2 unique V114 serotypes were measured with PnECL. The GMCs for each serotype are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes One month after Vaccination 4 (Month 13 to Month 16) Serotype-specific anti-PnP GMCs were measured with PnECL. The GMC for each serotype is reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 One month after Vaccination 3 (Month 7) Serotype 3-specific anti-PnP GMC was measured with PnECL.
Trial Locations
- Locations (81)
Kentucky Pediatric/Adult Research Inc ( Site 0136)
🇺🇸Bardstown, Kentucky, United States
Capitol Pediatrics & Adolescent Center ( Site 0223)
🇺🇸Raleigh, North Carolina, United States
Holston Medical Group ( Site 0165)
🇺🇸Kingsport, Tennessee, United States
University of Texas Medical Branch ( Site 0185)
🇺🇸Galveston, Texas, United States
Tufts Medical Center-Floating Hospital for Children ( Site 0129)
🇺🇸Boston, Massachusetts, United States
Senders Pediatrics ( Site 0190)
🇺🇸Cleveland, Ohio, United States
Cooperativa de Facultad Medica Sanacoop ( Site 0077)
🇵🇷Bayamon, Puerto Rico
Ventavia Research Group LLC ( Site 0142)
🇺🇸Houston, Texas, United States
Pediatric Associates ( Site 0209)
🇺🇸Houston, Texas, United States
Houston Clinical Research Network ( Site 0266)
🇺🇸Houston, Texas, United States
Khon Kaen University ( Site 0031)
🇹🇭Muang, Khon Kaen, Thailand
Southeastern Pediatric Associates, P.A. ( Site 0107)
🇺🇸Dothan, Alabama, United States
South Alabama Pediatrics ( Site 0263)
🇺🇸Opp, Alabama, United States
Northwest Arkansas Pediatric Clinic ( Site 0172)
🇺🇸Fayetteville, Arkansas, United States
Children's Clinic of Jonesboro, PA ( Site 0184)
🇺🇸Jonesboro, Arkansas, United States
Advanced Clinical Research - Rancho Paseo ( Site 0163)
🇺🇸Banning, California, United States
Altissima Clinical Research LLC ( Site 0213)
🇺🇸Bellflower, California, United States
Southland Clinical Research Center ( Site 0187)
🇺🇸Bellflower, California, United States
Premier Health Research Center, LLC ( Site 0121)
🇺🇸Downey, California, United States
Kaiser Permanente Vaccine Study Center - Oakland ( Site 0282)
🇺🇸Oakland, California, United States
Kaiser Permanente - San Jose ( Site 0258)
🇺🇸San Jose, California, United States
Kaiser Permanente - Santa Clara ( Site 0244)
🇺🇸Santa Clara, California, United States
Suncoast Research Associates, LLC ( Site 0250)
🇺🇸Miami, Florida, United States
Michael W Simon, MD., Pediatric & Adolescent Medicine ( Site 0276)
🇺🇸Nicholasville, Kentucky, United States
Saltzer Medical Group ( Site 0215)
🇺🇸Nampa, Idaho, United States
ACC Pediatric Research ( Site 0147)
🇺🇸Haughton, Louisiana, United States
Medpharmics, LLC ( Site 0157)
🇺🇸Metairie, Louisiana, United States
Virgo-Carter Pediatrics ( Site 0275)
🇺🇸Silver Spring, Maryland, United States
Pediatric Associates of Fall River ( Site 0183)
🇺🇸Fall River, Massachusetts, United States
Children's Mercy Clinics on Broadway ( Site 0171)
🇺🇸Kansas City, Missouri, United States
MediSync Clinical Research Hattiesburg Clinic ( Site 0259)
🇺🇸Petal, Mississippi, United States
Midwest Children's Health Research Institute, LLC ( Site 0109)
🇺🇸Lincoln, Nebraska, United States
Midwest Children's Health Research Institute, LLC ( Site 0106)
🇺🇸Lincoln, Nebraska, United States
Southwest CARE Center ( Site 0161)
🇺🇸Santa Fe, New Mexico, United States
Advantage Clinical Trials ( Site 0274)
🇺🇸Bronx, New York, United States
Child Health Care Associates ( Site 0242)
🇺🇸East Syracuse, New York, United States
Child Health Care Associates ( Site 0267)
🇺🇸Liverpool, New York, United States
Phramongkutklao Hospital ( Site 0033)
🇹🇭Bangkok, Thailand
Haywood Pediatric and Adolescent Medicine Group ( Site 0248)
🇺🇸Clyde, North Carolina, United States
Pediatric Medical Associates ( Site 0239)
🇺🇸East Norriton, Pennsylvania, United States
Dayton Clinical Research ( Site 0188)
🇺🇸Dayton, Ohio, United States
Cyn3rgy Research ( Site 0246)
🇺🇸Gresham, Oregon, United States
Allegheny Health & Wellness Pavilion West ( Site 0210)
🇺🇸Erie, Pennsylvania, United States
Lockman & Lubell Pediatrics ( Site 0166)
🇺🇸Fort Washington, Pennsylvania, United States
Cheraw Pediatrics ( Site 0280)
🇺🇸Cheraw, South Carolina, United States
CCP- Kid's Way ( Site 0130)
🇺🇸Hermitage, Pennsylvania, United States
Palmetto Pediatrics, PA ( Site 0164)
🇺🇸Charleston, South Carolina, United States
Parkside Pediatric ( Site 0125)
🇺🇸Greenville, South Carolina, United States
DFW Clinical Research ( Site 0111)
🇺🇸Dallas, Texas, United States
Ventavia Research Group LLC ( Site 0139)
🇺🇸Keller, Texas, United States
FMC Science ( Site 0115)
🇺🇸Lampasas, Texas, United States
University of Texas Medical Branch ( Site 0170)
🇺🇸League City, Texas, United States
DCOL Center for Clinical Research ( Site 0247)
🇺🇸Longview, Texas, United States
Pediatric Care ( Site 0138)
🇺🇸Provo, Utah, United States
Dixie Pediatrics ( Site 0260)
🇺🇸Saint George, Utah, United States
Cottonwood Pediatrics ( Site 0153)
🇺🇸Murray, Utah, United States
Wee Care Pediatrics ( Site 0154)
🇺🇸Layton, Utah, United States
Wee Care Pediatrics-Roy ( Site 0174)
🇺🇸Roy, Utah, United States
MultiCare Rockwood Cheney Clinic ( Site 0195)
🇺🇸Cheney, Washington, United States
Wee Care Pediatrics ( Site 0193)
🇺🇸Syracuse, Utah, United States
Multicare / Rockwood Clinic ( Site 0167)
🇺🇸Spokane, Washington, United States
Clinical Research of Puerto Rico ( Site 0075)
🇵🇷Guayama, Puerto Rico
CAIMED Center - Ponce School of Medicine ( Site 0076)
🇵🇷Ponce, Puerto Rico
San Juan Hospital ( Site 0079)
🇵🇷San Juan, Puerto Rico
University of Puerto Rico - Medical Science Campus ( Site 0078)
🇵🇷San Juan, Puerto Rico
Elba Antoniette Perez Vargas MD-Private Practice ( Site 0081)
🇵🇷Trujillo Alto, Puerto Rico
Siriraj Hospital ( Site 0032)
🇹🇭Bangkok, Thailand
Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0060)
🇹🇷Adana, Turkey
Maharaj Nakorn Chiang Mai Hospital ( Site 0030)
🇹🇭Chiang Mai, Thailand
Ankara Universitesi Tip Fakultesi ( Site 0053)
🇹🇷Ankara, Turkey
Ege University Medical Faculty Hospital ( Site 0050)
🇹🇷Izmir, Turkey
Dokuz Eylul University Faculty of Medicine ( Site 0054)
🇹🇷Izmir, Turkey
Erciyes Universitesi Tip Fakultesi ( Site 0057)
🇹🇷Kayseri, Turkey
Children's Health Center ( Site 0272)
🇺🇸Tampa, Florida, United States
Alabama Clinical Therapeutics ( Site 0159)
🇺🇸Birmingham, Alabama, United States
Kaiser Permanente - Sacramento ( Site 0257)
🇺🇸Sacramento, California, United States
Kaiser Permanente Vaccine Study Center - South Sacramento ( Site 0256)
🇺🇸Sacramento, California, United States
Children's Physicians, UNMC ( Site 0252)
🇺🇸Omaha, Nebraska, United States
University of Utah ( Site 0214)
🇺🇸Salt Lake City, Utah, United States
Davita Medical Group ( Site 0141)
🇺🇸Colorado Springs, Colorado, United States
Suncoast Research Associates, LLC ( Site 0249)
🇺🇸North Miami Beach, Florida, United States