A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
SARS-CoV-2 Infection, COVID-19
About this trial
This is an interventional prevention trial for SARS-CoV-2 Infection, COVID-19 focused on measuring COVID-19, Coronavirus Vaccine, SARS-CoV-2, RNA Vaccine, mRNA Vaccine
Eligibility Criteria
Inclusion Criteria
- Male or female participants ≥6 months to <12 years of age, at the time of randomization, at Visit 1 for the dose-finding/selected-dose evaluation and for participants ≥12 to <18 years of age, at the time of randomization, at Visit 1 for the lower-dose evaluation. For the obtaining-serum-samples-for-potential-troponin I-testing portion of the study: Male or female participants between ≥5 and <16 years of age.
- 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.
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.
- 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.
- Negative urine pregnancy test for female participants who are biologically capable of having children.
- 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.
- 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
- Phase 1 only: Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
- Phase 1 only: Known infection with HIV, HCV, or HBV.
- Receipt of medications intended to prevent COVID-19.
- Previous or current diagnosis of MIS-C.
- 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
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- 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.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Female who is pregnant or breastfeeding.
- Previous vaccination with any coronavirus vaccine.
- 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.
- 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.
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- Previous participation in other studies involving study intervention containing LNPs.
- 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.
Sites / Locations
- University of Alabama at Birmingham - School of Medicine
- Phoenix Children's Hospital
- Kaiser Permanente Los Angeles Medical Center
- SCPMG/Kaiser Permanente Los Angeles Medical Center
- Matrix Clinical Research
- Madera Family Medical Group
- Kaiser Permanente Oakland
- Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University
- Lucile Packard Children's Hospital Stanford
- Center for Clinical Trials, LLC
- Center for Clinical Trials
- Peninsula Research Associates
- Kaiser Permanente Sacramento
- Kaiser Permanente Santa Clara
- Stanford Health Care Investigational Drug Service
- Stanford Health Care
- Bayview Research Group, LLC
- Children's Hospital Colorado
- Yale Center for Clinical Investigation
- Children's National Medical Center
- Emerson Clinical Research Institute
- Meridian Clinical Research, LLC
- Clinical Neuroscience Solutions, Inc.
- Acevedo Clinical Research Associates
- Clinical Neuroscience Solutions
- Emory Children's Center Illness POD
- Emory University School of Medicine
- Atlanta Center for Medical Research
- Meridian Clinical Research, LLC
- Rophe Adult and Pediatric Medicine/SKYCRNG
- Clinical Research Prime
- Solaris Clinical Research
- Alliance for Multispecialty Research, LLC
- Alliance for Multispecialty Research, LLC
- Kentucky Pediatric/ Adult Research
- Novak Center for Children's Health
- Ochsner Clinic Foundation
- Louisiana State University Health Sciences Shreveport
- Johns Hopkins Bayview Medical Center
- Boston Medical Center
- Michigan Center of Medical Research
- Quinn Healthcare/SKYCRNG
- SKY Integrative Medical Center/SKYCRNG
- Clinical Research Professionals
- Children's Mercy Hospital
- Meridian Clinical Research, LLC
- Velocity Clinical Research, Lincoln
- Children's Hospital & Medical Center
- Children's Physician's Clinic, Spring Valley
- Rutgers University
- Meridian Clinical Research LLC
- Meridian Clinical Research, LLC
- Meridian Clinical Research LLC
- Advanced Specialty Care
- Clinical Research Center
- Rochester Clinical Research, Inc.
- University of Rochester Medical Center
- Stony Brook University
- SUNY Upstate Medical University
- Atrium Health-STRIVE Vaccine Research Clinic
- Teen Health Connection (study visits)
- Duke University - Main Hospital and Clinics
- Atrium Health-STRIVE Vaccine Research Clinic (study visits)
- Cincinnati Children's Hospital Medical Center
- Cincinnati Childrens Hospital Medical Center
- Aventiv Research Inc.
- Centricity Research Columbus Ohio Multispecialty
- PriMed Clinical Research
- PriMed Clinical Research
- Senders Pediatrics
- Cyn3rgy Research
- AHN Erie Health + Wellness Pavillion: West
- Velocity Clinical Research-Providence
- Coastal Pediatric Research
- Tribe Clinical Research, LLC
- Coastal Pediatric Research
- St. Jude Children's Research Hospital
- Clinical Research Associates Inc
- ARC Clinical Research at Four Points
- ARC Clinical Research at Wilson Parke
- Driscoll Children's Hospital
- Cedar Health Research
- Bay Colony Pediatrics
- Proactive Clinical Research, LLC
- Village Health Partners (Patient Seen Address)
- Helios Clinical Research - HOU
- Van Tran Family Practice
- Texas Children's Hospital - Clinical Research Center
- West Houston Clinical Research Services
- DM Clinical Research
- Pediatric Associates
- ACRC Trials (Administrative Site)
- J. Lewis Research, Inc. / Foothill Family Clinic
- J. Lewis Research, Inc. / Foothill Family Clinic South
- Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
- Pediatric Research of Charlottesville, LLC
- Virginia Research Center
- Seattle Children's Hospital
- Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC
- Santa Casa De Misericórdia de Belo Horizonte
- Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Franci
- CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda
- CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.
- Tampere Vaccine Research Clinic
- FVR, Oulu Clinic
- FVR, Helsinki East Clinic
- FVR, Järvenpää Clinic
- FVR, Helsinki East Clinic
- FVR, Espoo Clinic
- FVR, Helsinki South Clinic
- MeVac - Meilahti Vaccine Research Center
- FVR, Helsinki East Clinic
- FVR, Kokkola Clinic
- FVR, Pori Clinic
- FVR, Seinäjoki Clinic
- FVR, Tampere Clinic
- FVR, Turku Clinic
- CHRISTUS - LATAM HUB Center of excellence and innovation S.C.
- Kohler & Milstein Research S.A. de C.V.
- Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion
- Sociedad de Metabolismo y Corazón S.C.
- MICS Centrum Medyczne Torun
- IN-VIVO Bydgoszcz
- Centrum Badan Klinicznych JCI
- Osrodek Badan Klinicznych Appletreeclinics
- GRAVITA Diagnostyka i Leczenie nieplodnosci
- Rodzinne Centrum Medyczne LUBMED
- Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
- Provita 001
- CHUS - Hospital Clinico Universitario
- Hospital Clinico Universitario Santiago de Compostela
- EAP Centelles
- EBA Centelles
- Hospital Sant Joan de Deu
- Hospital Sant Joan de Deu
- Hospital Universitari General de Catalunya
- Hospital Universitario HM Puerta del Sur
- Hospital Universitario HM Monteprincipe
- Hospital de Antequera
- Hospital de Antequera
- Grupo Pediatrico Uncibay
- Hospital Universitario 12 de Octubre
- Hospital HM Puerta del Sur
- Instituto Hispalense de Pediatria
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Arm 19
Arm 20
Arm 21
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Low/Mid-Dose, ≥5 to <12 Years
Mid-Dose, ≥5 to <12 Years
High-Dose, ≥5 to <12 Years
Low/Mid-Dose, ≥2 to < 5 Years
Mid-Dose, ≥2 to <5 Years
High-Dose, ≥2 to <5 Years
Low/Mid-Dose, ≥6 Months to <2 Years
Mid-Dose, ≥6 Months to <2 Years
High-Dose, ≥6 Months to <2 Years
Placebo, ≥6 Months to <2 Years
Placebo, ≥2 to <5 Years
Placebo, ≥5 to <12 Years
Low-Dose, ≥6 Months to <2 Years
Low-Dose, ≥2 to <5 Years
High-Dose, 12 to <16 Years (Troponin I Testing)
Low/Mid-Dose, ≥5 to <12 Years (Troponin I Testing)
Placebo, ≥5 to <12 Years (Troponin I Testing)
Low-Dose, ≥6 Months to <2 Years (3-dose regimen)
Low-Dose, ≥2 to <5 Years (3-dose regimen)
Placebo, ≥6 Months to <2 Years (3-dose regimen)
Placebo, ≥2 to <5 Years (3-dose regimen)
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Mid-Dose, (20mcg), 2 doses 21 days apart
High-Dose (30mcg), 2 doses 21 days apart
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Mid-Dose, (20mcg), 2 doses 21 days apart
High-Dose, (30mcg), 2 doses 21 days apart
Low/Mid-Dose, (10mcg), 2 doses 21 days apart
Mid-Dose, (20mcg), 2 doses 21 days apart
High-Dose, (30mcg), 2 doses 21 days apart
Low-Dose (3mcg), 2 doses 21 doses apart
Low-Dose (3mcg), 2 doses 21 days apart
High-Dose (30mcg), 3 doses
Low/Mid-Dose (10mcg), 3 doses
Low-Dose (3mcg), 3 doses
Low-Dose (3mcg), 3 doses