A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
NCT ID: NCT04816643
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
11837 participants
INTERVENTIONAL
2021-03-24
2023-12-08
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Low/Mid-Dose, ≥5 to <12 Years
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Biological/Vaccine: BNT162b2 10mcg
BNT162b2 Low/Mid-Dose (10mcg) level
Mid-Dose, ≥5 to <12 Years
Mid-Dose, (20mcg), 2 doses 21 days apart
BNT162b2 20mcg
BNT162b2 Mid-Dose (20mcg) level
High-Dose, ≥5 to <12 Years
High-Dose (30mcg), 2 doses 21 days apart
BNT162b2 30mcg
BNT162b2 High-Dose (30mcg) level
Low/Mid-Dose, ≥2 to < 5 Years
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Biological/Vaccine: BNT162b2 10mcg
BNT162b2 Low/Mid-Dose (10mcg) level
Mid-Dose, ≥2 to <5 Years
Mid-Dose, (20mcg), 2 doses 21 days apart
BNT162b2 20mcg
BNT162b2 Mid-Dose (20mcg) level
High-Dose, ≥2 to <5 Years
High-Dose, (30mcg), 2 doses 21 days apart
BNT162b2 30mcg
BNT162b2 High-Dose (30mcg) level
Low/Mid-Dose, ≥6 Months to <2 Years
Low/Mid-Dose, (10mcg), 2 doses 21 days apart
Biological/Vaccine: BNT162b2 10mcg
BNT162b2 Low/Mid-Dose (10mcg) level
Mid-Dose, ≥6 Months to <2 Years
Mid-Dose, (20mcg), 2 doses 21 days apart
BNT162b2 20mcg
BNT162b2 Mid-Dose (20mcg) level
High-Dose, ≥6 Months to <2 Years
High-Dose, (30mcg), 2 doses 21 days apart
BNT162b2 30mcg
BNT162b2 High-Dose (30mcg) level
Placebo, ≥6 Months to <2 Years
Placebo
Intramuscular injection
Placebo, ≥2 to <5 Years
Placebo
Intramuscular injection
Placebo, ≥5 to <12 Years
Placebo
Intramuscular injection
Low-Dose, ≥6 Months to <2 Years
Low-Dose (3mcg), 2 doses 21 doses apart
Biological/Vaccine: BNT162b2 3mcg
BNT162b2 Low-Dose (3mcg) level
Low-Dose, ≥2 to <5 Years
Low-Dose (3mcg), 2 doses 21 days apart
Biological/Vaccine: BNT162b2 3mcg
BNT162b2 Low-Dose (3mcg) level
High-Dose, 12 to <16 Years (Troponin I Testing)
High-Dose (30mcg), 3 doses
BNT162b2 30mcg
BNT162b2 High-Dose (30mcg) level
Low/Mid-Dose, ≥5 to <12 Years (Troponin I Testing)
Low/Mid-Dose (10mcg), 3 doses
Biological/Vaccine: BNT162b2 10mcg
BNT162b2 Low/Mid-Dose (10mcg) level
Placebo, ≥5 to <12 Years (Troponin I Testing)
Placebo
Intramuscular injection
Low-Dose, ≥6 Months to <2 Years (3-dose regimen)
Low-Dose (3mcg), 3 doses
Biological/Vaccine: BNT162b2 3mcg
BNT162b2 Low-Dose (3mcg) level
Low-Dose, ≥2 to <5 Years (3-dose regimen)
Low-Dose (3mcg), 3 doses
Biological/Vaccine: BNT162b2 3mcg
BNT162b2 Low-Dose (3mcg) level
Placebo, ≥6 Months to <2 Years (3-dose regimen)
Placebo
Intramuscular injection
Placebo, ≥2 to <5 Years (3-dose regimen)
Placebo
Intramuscular injection
Interventions
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Biological/Vaccine: BNT162b2 10mcg
BNT162b2 Low/Mid-Dose (10mcg) level
BNT162b2 20mcg
BNT162b2 Mid-Dose (20mcg) level
BNT162b2 30mcg
BNT162b2 High-Dose (30mcg) level
Placebo
Intramuscular injection
Biological/Vaccine: BNT162b2 3mcg
BNT162b2 Low-Dose (3mcg) level
Eligibility Criteria
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Inclusion Criteria
2. Participants' parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in the therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
4. Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation.
5. Negative urine pregnancy test for female participants who are biologically capable of having children.
6. Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children.
7. The participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written).
Exclusion Criteria
2. Phase 1 only: Known infection with HIV, HCV, or HBV.
3. Receipt of medications intended to prevent COVID-19.
4. Previous or current diagnosis of MIS-C.
5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results
6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
7. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
8. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
10. Female who is pregnant or breastfeeding.
11. Previous vaccination with any coronavirus vaccine.
12. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
13. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study.
14. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
15. Previous participation in other studies involving study intervention containing LNPs.
16. Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
6 Months
15 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
BioNTech SE
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
SCPMG/Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Matrix Clinical Research
Los Angeles, California, United States
Madera Family Medical Group
Madera, California, United States
Kaiser Permanente Oakland
Oakland, California, United States
Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University
Palo Alto, 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
Kaiser Permanente Sacramento
Sacramento, California, United States
Kaiser Permanente Santa Clara
Santa Clara, California, United States
Stanford Health Care Investigational Drug Service
Stanford, California, United States
Stanford Health Care
Stanford, California, United States
Bayview Research Group, LLC
Valley Village, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Yale Center for Clinical Investigation
New Haven, Connecticut, United States
Emerson Clinical Research Institute - Washington - Connecticut Avenue
Washington D.C., District of Columbia, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States
Meridian Clinical Research, LLC
Washington D.C., District of Columbia, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Emory Children's Center Illness POD
Atlanta, Georgia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Meridian Clinical Research, LLC
Macon, 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
Newton, Kansas, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Novak Center for Children's Health
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Michigan Center of Medical Research
Bingham Farms, Michigan, United States
Quinn Healthcare/SKYCRNG
Ridgeland, Mississippi, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Meridian Clinical Research, LLC
Hastings, Nebraska, United States
Velocity Clinical Research, Lincoln
Lincoln, Nebraska, United States
Children's Hospital & Medical Center
Omaha, Nebraska, United States
Children's Physician's Clinic, Spring Valley
Omaha, Nebraska, United States
Rutgers University
New Brunswick, New Jersey, United States
Meridian Clinical Research LLC
Binghamton, New York, United States
Meridian Clinical Research, LLC
Binghamton, 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
Rochester Clinical Research, Inc.
Rochester, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Stony Brook University
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Atrium Health-STRIVE Vaccine Research Clinic
Charlotte, North Carolina, United States
Teen Health Connection (study visits)
Charlotte, North Carolina, United States
Duke University - Main Hospital and Clinics
Durham, North Carolina, United States
Duke Vaccine And Trials Unit
Durham, North Carolina, United States
Atrium Health-STRIVE Vaccine Research Clinic (study visits)
Matthews, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Aventiv Research Inc.
Columbus, Ohio, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States
PriMed Clinical Research
Dayton, Ohio, 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
Charleston, South Carolina, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, United States
Coastal Pediatric Research
Summerville, South Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Clinical Research Associates Inc
Nashville, Tennessee, United States
ARC Clinical Research at Four Points
Austin, Texas, United States
ARC Clinical Research at Wilson Parke
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Cedar Health Research
Dallas, Texas, United States
Bay Colony Pediatrics
Dickinson, Texas, United States
Proactive Clinical Research, LLC
Edinburg, Texas, United States
Village Health Partners (Patient Seen Address)
Frisco, Texas, United States
Helios Clinical Research - HOU
Houston, Texas, United States
Van Tran Family Practice
Houston, Texas, United States
Texas Children's Hospital - Clinical Research Center
Houston, Texas, United States
West Houston Clinical Research Services
Houston, Texas, United States
DM Clinical Research
Houston, Texas, United States
Pediatric Associates
Houston, Texas, United States
ACRC Trials (Administrative Site)
Plano, Texas, 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
Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
Charlottesville, Virginia, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Virginia Research Center
Midlothian, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC
Salvador, Estado de Bahia, Brazil
Santa Casa De Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Franci
Curitiba, Paraná, Brazil
CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda
Natal, Rio Grande do Norte, Brazil
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.
São Paulo, , Brazil
FVR, Oulu Clinic
Oulu, North Ostrobothnia, Finland
Tampere Vaccine Research Clinic
Tampere, Pirkanmaa, Finland
FVR, Helsinki East Clinic
Helsinki, Southwest Finland, Finland
FVR, Helsinki East Clinic
Helsinki, Uusimaa, Finland
FVR, Järvenpää Clinic
Järvenpää, Uusimaa, Finland
FVR, Espoo Clinic
Espoo, , Finland
FVR, Helsinki South Clinic
Helsinki, , Finland
MeVac - Meilahti Vaccine Research Center
Helsinki, , Finland
FVR, Helsinki East Clinic
Helsinki, , Finland
FVR, Kokkola Clinic
Kokkola, , Finland
FVR, Pori Clinic
Pori, , Finland
FVR, Seinäjoki Clinic
Seinäjoki, , Finland
FVR, Tampere Clinic
Tampere, , Finland
FVR, Turku Clinic
Turku, , Finland
CHRISTUS - LATAM HUB Center of excellence and innovation S.C.
Monterrey, Nuevo León, Mexico
Kohler & Milstein Research S.A. de C.V.
Mérida, Yucatán, Mexico
Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion
Mérida, Yucatán, Mexico
Sociedad de Metabolismo y Corazón S.C.
Veracruz, , Mexico
MICS Centrum Medyczne Torun
Torun, Kuyavian-Pomeranian Voivodeship, Poland
IN-VIVO Bydgoszcz
Bydgoszcz, , Poland
Centrum Badan Klinicznych JCI
Krakow, , Poland
Osrodek Badan Klinicznych Appletreeclinics
Lodz, , Poland
GRAVITA Diagnostyka i Leczenie nieplodnosci
Lodz, , Poland
Rodzinne Centrum Medyczne LUBMED
Luboń, , Poland
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
Siemianowice Śląskie, , Poland
Provita 001
Warsaw, , Poland
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruna, Spain
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
EAP Centelles
Centelles, Barcelona, Spain
EBA Centelles
Centelles, Barcelona, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregrat, Barcelona, Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, Spain
Hospital Universitario HM Puerta del Sur
Madrid, Madrid, Comunidad de, Spain
Hospital de Antequera
Antequera, Malaga, Spain
Hospital de Antequera
Antequera, Málaga, Spain
Grupo Pediatrico Uncibay
Málaga, Málaga, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital HM Puerta del Sur
Móstoles, , Spain
Instituto Hispalense de Pediatria
Seville, , Spain
Countries
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References
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Pather S, Charpentier N, van den Ouweland F, Rizzi R, Finlayson A, Salisch N, Muik A, Lindemann C, Khanim R, Abduljawad S, Smith ER, Gurwith M, Chen RT; Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG). A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine. Vaccine. 2024 Sep 17;42(22):126165. doi: 10.1016/j.vaccine.2024.126165. Epub 2024 Aug 27.
Simoes EAF, Klein NP, Sabharwal C, Gurtman A, Kitchin N, Ukkonen B, Korbal P, Zou J, Xie X, Sarwar UN, Xu X, Lockhart S, Cunliffe L, Lu C, Ma H, Swanson KA, Koury K, Shi PY, Cooper D, Tureci Ӧ, Jansen KU, Sahin U, Gruber WC. Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5- to 11-Year Olds. J Pediatric Infect Dis Soc. 2023 Apr 28;12(4):234-238. doi: 10.1093/jpids/piad015.
Munoz FM, Sher LD, Sabharwal C, Gurtman A, Xu X, Kitchin N, Lockhart S, Riesenberg R, Sexter JM, Czajka H, Paulsen GC, Maldonado Y, Walter EB, Talaat KR, Englund JA, Sarwar UN, Hansen C, Iwamoto M, Webber C, Cunliffe L, Ukkonen B, Martinez SN, Pahud BA, Munjal I, Domachowske JB, Swanson KA, Ma H, Koury K, Mather S, Lu C, Zou J, Xie X, Shi PY, Cooper D, Tureci O, Sahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age. N Engl J Med. 2023 Feb 16;388(7):621-634. doi: 10.1056/NEJMoa2211031.
Walter EB, Talaat KR, Sabharwal C, Gurtman A, Lockhart S, Paulsen GC, Barnett ED, Munoz FM, Maldonado Y, Pahud BA, Domachowske JB, Simoes EAF, Sarwar UN, Kitchin N, Cunliffe L, Rojo P, Kuchar E, Ramet M, Munjal I, Perez JL, Frenck RW Jr, Lagkadinou E, Swanson KA, Ma H, Xu X, Koury K, Mather S, Belanger TJ, Cooper D, Tureci O, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2022 Jan 6;386(1):35-46. doi: 10.1056/NEJMoa2116298. Epub 2021 Nov 9.
Related Links
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Other Identifiers
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2020-005442-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C4591007
Identifier Type: -
Identifier Source: org_study_id