A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
- Conditions
- SARS-CoV-2 Infection, COVID-19
- Interventions
- Biological: BNT162b2 20mcgBiological: BNT162b2 30mcgOther: Placebo
- Registration Number
- NCT04816643
- Lead Sponsor
- BioNTech SE
- Brief Summary
This is a Phase 1/2/3 study in healthy children.
Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants \<6 months of age may subsequently be evaluated.
- Detailed Description
Phase 1 Dose-Finding
Is the open-label dose-finding portion of the study that will evaluate safety, tolerability, and immunogenicity of BNT162b2 administered on a 2-dose (separated by approximately 21 days) schedule in up to 3 age groups (participants ≥5 to \<12 years, ≥2 to \<5 years, and ≥6 months to \<2 years of age).
Dose finding is being initiated in this study in participants ≥5 to \<12 years of age based on the acceptable blinded safety assessment of the 30-µg dose in 12- to 15-year-olds in the C4591001 study.
The purpose of Phase 1 is to identify preferred dose level(s) of BNT162b2 from up to 3 different dose levels in each age group.
Dependent upon safety and/or immunogenicity data generated during the course of this study, it is possible that dose levels may not be started, may be terminated early, and/or may be added with dose levels below the lowest stated dose.
Update as part of protocol amendment 6: All participants will receive a third dose of BNT162b2. For participants ≥6 months to \<5 years, the third dose will occur at least 8 weeks after the second dose. In participants ≥5 to \<12 years, the third dose will occur at least 6 months after the second dose. The interval between the second and third doses will be based on the participant's age at the time of enrollment. The dose level of the third dose of BNT162b2 will be based on age at the time of vaccination: participants \<5 years of age at the time of the third dose will receive the 3-µg dose level, participants ≥5 to \<12 years of age at the time of the third dose will receive the 10-µg dose level, and participants ≥12 years of age at the time of the third dose will receive the 30-µg dose level.
Participants will have blood drawn prior to both Dose 1 and Dose 2 and 7 days after Dose 2 to assess immunogenicity to determine the selected BNT162b2 dose level for Phase 2/3. Participants will also have blood drawn prior to Dose 3 and 1, 6, and 12 months after Dose 3.
Phase 2/3 Selected-Dose
Is the portion of the study that will evaluate the safety, tolerability, and immunogenicity in each age group at the selected dose level from the Phase 1 dose-finding portion of the study. Efficacy will be evaluated within or across age groups in which immunobridging is successful, depending on accrual of a sufficient number of cases in those age groups.
Participants will have blood drawn at baseline prior to Dose 1 and 6 months after Dose 2. Immunobridging to participants 16 to 25 years of age in the C4591001 study will be based on immunogenicity data collected at (1) baseline and 1 month after Dose 2 and (2) baseline and 1 month after Dose 3. The persistence of the immune response will be based on immunogenicity data collected in participants at (1) baseline and 1 and 6 months after Dose 2 and (2) baseline and 1, 6, 12, and 18 months after Dose 3. In addition, efficacy against confirmed COVID-19 and against asymptomatic infection will also be assessed in participants ≥5 to \<12 years of age.
At designated US sites, an additional optional whole blood sample of approximately 10 mL will be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately 60 participants ≥10 years of age. Additional samples will be obtained prior to Dose 3 and 1 month after Dose 3 (original BNT162b2 group only). These samples will be used on an exploratory basis to investigate the postvaccination cell-mediated immune response at these time points.
At the 6-month follow-up visit, all participants will be unblinded. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 as part of the study. Participants who originally received placebo and become eligible for receipt of BNT162b2 or another COVID-19 vaccine according to local or national recommendations prior to the 6 month follow-up visit (Visit 5 or 405) (detailed separately and available in the electronic study reference portal) will have the opportunity to receive BNT162b2 (10 µg or 3 µg) based on age at the time of vaccination.
Update as part of protocol amendment 6: All participants will receive a third dose of BNT162b2. For participants ≥6 months to \<5 years, the third dose will occur at least 8 weeks after the second dose. In participants ≥5 to \<12 years, the third dose will occur at least 6 months after the second dose. The interval between the second and third doses will be based on the participant's age at the time of enrollment. The dose level of the second and third doses of BNT162b2 will be based on age at the time of vaccination: participants \<5 years of age at the time of the second/third dose will receive the 3-µg dose level, participants ≥5 to \<12 years of age at the time of the second/third dose will receive the 10-µg dose level, and participants ≥12 years of age at the time of the second/third dose will receive the 30-µg dose level.
Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing
If testing of troponin I levels in individuals who did not receive BNT162b2 indicates that troponin I level could be a reliable indicator of potential subclinical myocarditis, obtaining serum samples for potential troponin I testing during the period of increased risk of clinical myocarditis may help characterize the absence/presence and frequency of subclinical myocarditis. To assess, an additional group of participants will be included: ≥5 to \<12 years: randomized 2:1 to receive BNT162b2 10 µg or placebo, and ≥12 to \<16 years of age: open-label receipt of BNT162b2 30 µg.
Update as part of protocol amendment 7: All participants will receive a third dose of BNT162b2. For all participants (≥5 to \<12 and ≥12 to \<16 years of age), the third dose will occur at least 5 months after Dose 2.
The dose level of the second and third doses of BNT162b2 will be based on age at the time of vaccination: participants ≥5 to \<12 years of age at the time of the second/third dose will receive the 10-µg dose level, and participants ≥12 years of age at the time of the second/third dose will receive the 30-µg dose level.
Update as part of protocol amendment 8: The Lower-Dose Evaluation portion of the protocol has been removed.
Participation in the study will cease 6 months after the third dose of BNT162b2.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11837
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mid-Dose, ≥5 to <12 Years BNT162b2 20mcg Mid-Dose, (20mcg), 2 doses 21 days apart Mid-Dose, ≥2 to <5 Years BNT162b2 20mcg Mid-Dose, (20mcg), 2 doses 21 days apart High-Dose, ≥5 to <12 Years BNT162b2 30mcg High-Dose (30mcg), 2 doses 21 days apart Placebo, ≥5 to <12 Years Placebo - High-Dose, 12 to <16 Years (Troponin I Testing) BNT162b2 30mcg High-Dose (30mcg), 3 doses Placebo, ≥2 to <5 Years (3-dose regimen) Placebo - High-Dose, ≥2 to <5 Years BNT162b2 30mcg High-Dose, (30mcg), 2 doses 21 days apart Mid-Dose, ≥6 Months to <2 Years BNT162b2 20mcg Mid-Dose, (20mcg), 2 doses 21 days apart High-Dose, ≥6 Months to <2 Years BNT162b2 30mcg High-Dose, (30mcg), 2 doses 21 days apart Placebo, ≥5 to <12 Years (Troponin I Testing) Placebo - Placebo, ≥6 Months to <2 Years (3-dose regimen) Placebo - Placebo, ≥6 Months to <2 Years Placebo - Placebo, ≥2 to <5 Years Placebo -
- Primary Outcome Measures
Name Time Method In Phase 2/3 selected-dose (2-dose series), the difference in percentages of participants with seroresponse in participants ≥2 to <5 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 1 month after the second dose As measured at the central laboratory
Percentage of participants in Phase 1 reporting local reactions for 7 days after Dose 1 and Dose 2 Pain or tenderness at the injection site, redness and swelling as reported on electronic diaries.
Percentage of participants in Phase 1 reporting serious adverse events from Dose 1 through 6 months after the last dose As elicited by investigational site staff
Percentage of participants in Phase 2/3 reporting adverse events from Dose 1 through 1 month after the last dose As elicited by investigational site staff
Percentage of participants in Phase 2/3 reporting serious adverse events from Dose 1 through 6 months after the last dose As elicited by investigational site staff
Percentage of participants in Phase 2/3 reporting systemic events for 7 days after Dose 1 and Dose 2 Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain, decreased appetite, drowsiness, and irritability as reported on electronic diaries
Percentage of participants in Phase 1 reporting adverse events from Dose 1 through 1 month after the last dose As elicited by investigational site staff
In Phase 2/3 selected-dose (2-dose series), the difference in percentages of participants with seroresponse in participants ≥5 to <12 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 1 month after the second dose As measured at the central laboratory
Percentage of participants in Phase 1 reporting systemic events for 7 days after Dose 1 and Dose 2 Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened join pain, decreased appetite drowsiness, and irritability as reported on electronic diaries
Ph 2/3 selected-dose (2-dose series), immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥2 to <5 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in the C4591001 study 1 month after the second dose As measured at the central laboratory
Ph 2/3 selected-dose (2-dose series), immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥6 months to <2 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 in C4591001 study 1 month after the second dose As measured at the central laboratory
Percentage of participants in Phase 2/3 reporting local reaction for 7 days after Dose 1 and Dose 2 Pain or tenderness at the injection site, redness and swelling as reported on electronic diaries.
Ph 2/3 selected-dose (2-dose series), immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥5 to <12 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in the C4591001 study 1 month after the second dose As measured at the central laboratory
In Phase 2/3 selected-dose (2-dose series), the difference in percentages of participants with seroresponse in participants ≥6 months to <2 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 1 month after the second dose As measured at the central laboratory
Ph 2/3 selected-dose (3-dose), immunobridging SARS-CoV-2 serum neutralizing titers after 3 doses in participants ≥6 months to <2 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in C4591001 participants 16 to 25 in study after 2 doses 1 month after the third dose As measured at the central laboratory
In Phase 2/3 selected-dose (3-dose series), the difference in percentages of participants with seroresponse in participants ≥2 to <5 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study 1 month after the third dose As measured at the central laboratory
In Phase 2/3 selected-dose (3-dose series), the difference in percentages of participants with seroresponse in participants ≥6 months to <2 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 1 month after the third dose As measured at the central laboratory
Ph 2/3 selected-dose (3-dose series), immunobridging of SARS-CoV-2 serum neutralizing titers after 3 doses in participants ≥2 to <5 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in C4591001 participants 16 to 25 years after 2 doses 1 month after the third dose As measured at the central laboratory
- Secondary Outcome Measures
Name Time Method In evaluable Phase 2/3 participants at selected dose level in each age group, Geometric Mean Titers of SARS-CoV-2 neutralizing titers with no serological or virological evidence of past SARS-CoV-2 infection At baseline (before Dose 1) and 1, 6, 12 (for the original BNT162b2 group only), and 24 (for the original BNT162b2 group only) months after Dose 2 As measured at the central laboratory
Ratio of confirmed COVID-19 illness, Phase 2/3 selected-dose participants ≥5 to <12 years of age with successful immunobridging, with and without evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group From 7 days after the second dose to prior to third dose Per 1000 person-years of follow-up
Ratio of confirmed COVID-19 illness, Phase 2/3 selected-dose participants ≥6 months to <5 years of age (3-dose series), evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group From 7 days after the third dose 1000 person-years of follow-up
Ratio of confirmed COVID-19 illness, Phase 2/3 selected-dose participants ≥5 to <12 years of age with successful immunobridging, without evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group From 7 days after the second dose to prior to third dose Per 1000 person-years of follow-up
In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs At each time point As measured at the central laboratory
In evaluable Phase 2/3 participants at the dose level selected in each age group, Geometric Mean Fold Ratio in SARS-CoV-2 serum neutralizing titer from before vaccination to each subsequent time point From before Dose 1 to each subsequent time point after Dose 2 As measured at the central laboratory
Ratio of confirmed COVID-19 illness, Phase 2/3 selected-dose participants ≥6 months to <5 years of age (3-dose series), with and without evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group From 7 days after the third dose 1000 person-years of follow-up
Trial Locations
- Locations (135)
Madera Family Medical Group
🇺🇸Madera, California, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
SKY Integrative Medical Center/SKYCRNG
🇺🇸Ridgeland, Mississippi, United States
Stony Brook University
🇺🇸Stony Brook, New York, United States
Louisiana State University Health Sciences Shreveport
🇺🇸Shreveport, Louisiana, United States
FVR, Seinäjoki Clinic
🇫🇮Seinajoki, Finland
MeVac - Meilahti Vaccine Research Center
🇫🇮Helsinki, Finland
FVR, Pori Clinic
🇫🇮Pori, Finland
Kohler & Milstein Research S.A. de C.V.
🇲🇽Merida, Yucatan, Mexico
Centrum Badan Klinicznych JCI
🇵🇱Krakow, Poland
FVR, Kokkola Clinic
🇫🇮Kokkola, Finland
FVR, Turku Clinic
🇫🇮Turku, Finland
CHRISTUS - LATAM HUB Center of excellence and innovation S.C.
🇲🇽Monterrey, Nuevo LEÓN, Mexico
Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion
🇲🇽Merida, Yucatan, Mexico
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
🇵🇱Siemianowice Slaskie, Poland
Hospital de Antequera
🇪🇸Antequera, Málaga, Spain
Aventiv Research Inc.
🇺🇸Columbus, Ohio, United States
Centricity Research Columbus Ohio Multispecialty
🇺🇸Columbus, Ohio, United States
Helios Clinical Research - HOU
🇺🇸Houston, Texas, United States
Van Tran Family Practice
🇺🇸Houston, Texas, United States
DM Clinical Research
🇺🇸Houston, Texas, United States
Pediatric Associates
🇺🇸Houston, Texas, United States
Village Health Partners (Patient Seen Address)
🇺🇸Frisco, Texas, United States
Cedar Health Research
🇺🇸Dallas, Texas, United States
Bay Colony Pediatrics
🇺🇸Dickinson, Texas, United States
ACRC Trials (Administrative Site)
🇺🇸Plano, Texas, United States
Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
🇺🇸Charlottesville, Virginia, United States
Virginia Research Center
🇺🇸Midlothian, Virginia, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Texas Children's Hospital - Clinical Research Center
🇺🇸Houston, Texas, United States
Pediatric Research of Charlottesville, LLC
🇺🇸Charlottesville, Virginia, United States
Proactive Clinical Research, LLC
🇺🇸Edinburg, Texas, United States
West Houston Clinical Research Services
🇺🇸Houston, Texas, United States
FVR, Tampere Clinic
🇫🇮Tampere, Finland
Osrodek Badan Klinicznych Appletreeclinics
🇵🇱Lodz, Poland
EBA Centelles
🇪🇸Centelles, Barcelona, Spain
FVR, Oulu Clinic
🇫🇮Oulu, Pohjois-pohjanmaa, Finland
Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Franci
🇧🇷Curitiba, Paraná, Brazil
FVR, Espoo Clinic
🇫🇮Espoo, Finland
EAP Centelles
🇪🇸Centelles, Barcelona, Spain
Hospital Universitari General de Catalunya
🇪🇸Sant Cugat del Valles, Barcelona, Spain
Hospital Universitario HM Monteprincipe
🇪🇸Boadilla del Monte, Madrid, Spain
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.
🇧🇷Sao Paulo, Brazil
IN-VIVO Bydgoszcz
🇵🇱Bydgoszcz, Poland
GRAVITA Diagnostyka i Leczenie nieplodnosci
🇵🇱Lodz, Poland
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario HM Puerta del Sur
🇪🇸Madrid, Madrid, Comunidad DE, Spain
Duke Vaccine And Trials Unit
🇺🇸Durham, North Carolina, United States
Cincinnati Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda
🇧🇷Natal, RIO Grande DO Norte, Brazil
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
University of Alabama at Birmingham - School of Medicine
🇺🇸Birmingham, Alabama, United States
Children's Hospital & Medical Center
🇺🇸Omaha, Nebraska, United States
Clinical Research Associates Inc
🇺🇸Nashville, Tennessee, United States
J. Lewis Research, Inc. / Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Santa Casa De Misericórdia de Belo Horizonte
🇧🇷Belo Horizonte, MG, Brazil
SCPMG/Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University
🇺🇸Palo Alto, California, United States
Matrix Clinical Research
🇺🇸Los Angeles, California, United States
Kaiser Permanente Oakland
🇺🇸Oakland, California, United States
Lucile Packard Children's Hospital Stanford
🇺🇸Palo Alto, California, United States
Center for Clinical Trials, LLC
🇺🇸Paramount, California, United States
Center for Clinical Trials
🇺🇸Paramount, California, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Stanford Health Care Investigational Drug Service
🇺🇸Stanford, California, United States
Kaiser Permanente Santa Clara
🇺🇸Santa Clara, California, United States
Stanford Health Care
🇺🇸Stanford, California, United States
Bayview Research Group, LLC
🇺🇸Valley Village, California, United States
Emerson Clinical Research Institute - Washington - Connecticut Avenue
🇺🇸Washington, District of Columbia, United States
Meridian Clinical Research, LLC
🇺🇸Binghamton, New York, United States
Emerson Clinical Research Institute
🇺🇸Washington, District of Columbia, United States
Acevedo Clinical Research Associates
🇺🇸Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
Emory Children's Center Illness POD
🇺🇸Atlanta, Georgia, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Alliance for Multispecialty Research, LLC
🇺🇸Wichita, Kansas, United States
Kentucky Pediatric/ Adult Research
🇺🇸Bardstown, Kentucky, United States
Michigan Center of Medical Research
🇺🇸Bingham Farms, Michigan, United States
Quinn Healthcare/SKYCRNG
🇺🇸Ridgeland, Mississippi, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Velocity Clinical Research, Lincoln
🇺🇸Lincoln, Nebraska, United States
Children's Physician's Clinic, Spring Valley
🇺🇸Omaha, Nebraska, United States
Rutgers University
🇺🇸New Brunswick, New Jersey, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Meridian Clinical Research LLC
🇺🇸Binghamton, New York, United States
Advanced Specialty Care
🇺🇸Commack, New York, United States
Clinical Research Center
🇺🇸East Setauket, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Atrium Health-STRIVE Vaccine Research Clinic
🇺🇸Charlotte, North Carolina, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Teen Health Connection (study visits)
🇺🇸Charlotte, North Carolina, United States
Duke University - Main Hospital and Clinics
🇺🇸Durham, North Carolina, United States
Atrium Health-STRIVE Vaccine Research Clinic (study visits)
🇺🇸Matthews, North Carolina, United States
PriMed Clinical Research
🇺🇸Dayton, Ohio, United States
Senders Pediatrics
🇺🇸South Euclid, Ohio, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
AHN Erie Health + Wellness Pavillion: West
🇺🇸Erie, Pennsylvania, United States
Velocity Clinical Research-Providence
🇺🇸East Greenwich, Rhode Island, United States
Coastal Pediatric Research
🇺🇸Summerville, South Carolina, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC
🇧🇷Salvador, Bahia, Brazil
Tampere Vaccine Research Clinic
🇫🇮Tampere, Pirkanmaa, Finland
FVR, Helsinki East Clinic
🇫🇮Helsinki, Finland
FVR, Järvenpää Clinic
🇫🇮Jarvenpaa, Uusimaa, Finland
FVR, Helsinki South Clinic
🇫🇮Helsinki, Finland
MICS Centrum Medyczne Torun
🇵🇱Torun, Kujawsko-pomorskie, Poland
Sociedad de Metabolismo y Corazón S.C.
🇲🇽Veracruz, Mexico
Rodzinne Centrum Medyczne LUBMED
🇵🇱Lubon, Poland
Hospital Clinico Universitario Santiago de Compostela
🇪🇸Santiago de Compostela, A Coruña, Spain
Provita 001
🇵🇱Warszawa, Poland
CHUS - Hospital Clinico Universitario
🇪🇸Santiago de Compostela, A Coruna, Spain
Hospital Sant Joan de Deu
🇪🇸Esplugues De Llobregrat, Barcelona, Spain
Grupo Pediatrico Uncibay
🇪🇸Malaga, Málaga, Spain
Instituto Hispalense de Pediatria
🇪🇸Sevilla, Spain
Hospital HM Puerta del Sur
🇪🇸Mostoles, Spain
Yale Center for Clinical Investigation
🇺🇸New Haven, Connecticut, United States
Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
Novak Center for Children's Health
🇺🇸Louisville, Kentucky, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Kaiser Permanente Sacramento
🇺🇸Sacramento, California, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
ARC Clinical Research at Four Points
🇺🇸Austin, Texas, United States
ARC Clinical Research at Wilson Parke
🇺🇸Austin, Texas, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States