Clinical trial NCT04816643: A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
Official title: A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: SARS-CoV-2 Infection, COVID-19
Keywords: COVID-19
Coronavirus Vaccine
SARS-CoV-2
RNA Vaccine
mRNA Vaccine
Lead sponsor: BioNTech SE
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2021-03-25
Enrollment: 11837
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria

1. 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. 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.
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

1. 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.
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.

Primary outcomes:
measure: Percentage of participants in Phase 1 reporting local reactions
timeFrame: for 7 days after Dose 1 and Dose 2
measure: Percentage of participants in Phase 1 reporting systemic events
timeFrame: for 7 days after Dose 1 and Dose 2
measure: Percentage of participants in Phase 1 reporting adverse events
timeFrame: from Dose 1 through 1 month after the last dose
measure: Percentage of participants in Phase 1 reporting serious adverse events
timeFrame: from Dose 1 through 6 months after the last dose
measure: Percentage of participants in Phase 2/3 reporting local reaction
timeFrame: for 7 days after Dose 1 and Dose 2
measure: Percentage of participants in Phase 2/3 reporting systemic events
timeFrame: for 7 days after Dose 1 and Dose 2
measure: Percentage of participants in Phase 2/3 reporting adverse events
timeFrame: from Dose 1 through 1 month after the last dose
measure: Percentage of participants in Phase 2/3 reporting serious adverse events
timeFrame: from Dose 1 through 6 months after the last dose
measure: 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
timeFrame: 1 month after the second dose
measure: 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
timeFrame: 1 month after the second dose
measure: 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
timeFrame: 1 month after the second dose
measure: 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
timeFrame: 1 month after the second dose
measure: 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
timeFrame: 1 month after the second dose
measure: 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
timeFrame: 1 month after the second dose
measure: 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
timeFrame: 1 month after the third dose
measure: 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
timeFrame: 1 month after the third dose
measure: 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
timeFrame: 1 month after the third dose
measure: 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
timeFrame: 1 month after the third dose
Secondary outcomes:
measure: In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs
timeFrame: At each time point
measure: 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
timeFrame: 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
measure: 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
timeFrame: From before Dose 1 to each subsequent time point after Dose 2
measure: 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
timeFrame: From 7 days after the second dose to prior to third dose
measure: 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
timeFrame: From 7 days after the second dose to prior to third dose
measure: 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
timeFrame: From 7 days after the third dose
measure: 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
timeFrame: From 7 days after the third dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - School of Medicine
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: SCPMG/Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland
state: California
city: Palo Alto
country: United States
facility: Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara
state: California
city: Stanford
country: United States
facility: Stanford Health Care Investigational Drug Service
state: California
city: Stanford
country: United States
facility: Stanford Health Care
state: California
city: Valley Village
country: United States
facility: Bayview Research Group, LLC
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation
state: Connecticut
city: Washington
country: United States
facility: Emerson Clinical Research Institute - Washington - Connecticut Avenue
state: District of Columbia
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Emerson Clinical Research Institute
state: District of Columbia
city: Washington
country: United States
facility: Meridian Clinical Research, LLC
state: District of Columbia
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Atlanta
country: United States
facility: Emory Children's Center Illness POD
state: Georgia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Macon
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/ Adult Research
state: Kentucky
city: Louisville
country: United States
facility: Novak Center for Children's Health
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Bingham Farms
country: United States
facility: Michigan Center of Medical Research
state: Michigan
city: Ridgeland
country: United States
facility: Quinn Healthcare/SKYCRNG
state: Mississippi
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Mississippi
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Hastings
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Lincoln
country: United States
facility: Velocity Clinical Research, Lincoln
state: Nebraska
city: Omaha
country: United States
facility: Children's Hospital & Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Children's Physician's Clinic, Spring Valley
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: Binghamton
country: United States
facility: Meridian Clinical Research LLC
state: New York
city: Binghamton
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Binghamton
country: United States
facility: Meridian Clinical Research LLC
state: New York
city: Commack
country: United States
facility: Advanced Specialty Care
state: New York
city: East Setauket
country: United States
facility: Clinical Research Center
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charlotte
country: United States
facility: Atrium Health-STRIVE Vaccine Research Clinic
state: North Carolina
city: Charlotte
country: United States
facility: Teen Health Connection (study visits)
state: North Carolina
city: Durham
country: United States
facility: Duke University - Main Hospital and Clinics
state: North Carolina
city: Durham
country: United States
facility: Duke Vaccine And Trials Unit
state: North Carolina
city: Matthews
country: United States
facility: Atrium Health-STRIVE Vaccine Research Clinic (study visits)
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc.
state: Ohio
city: Columbus
country: United States
facility: Centricity Research Columbus Ohio Multispecialty
state: Ohio
city: Dayton
country: United States
facility: PriMed Clinical Research
state: Ohio
city: Dayton
country: United States
facility: PriMed Clinical Research
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Erie
country: United States
facility: AHN Erie Health + Wellness Pavillion: West
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research-Providence
state: Rhode Island
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Summerville
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates Inc
state: Tennessee
city: Austin
country: United States
facility: ARC Clinical Research at Four Points
state: Texas
city: Austin
country: United States
facility: ARC Clinical Research at Wilson Parke
state: Texas
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: Dickinson
country: United States
facility: Bay Colony Pediatrics
state: Texas
city: Edinburg
country: United States
facility: Proactive Clinical Research, LLC
state: Texas
city: Frisco
country: United States
facility: Village Health Partners (Patient Seen Address)
state: Texas
city: Houston
country: United States
facility: Helios Clinical Research - HOU
state: Texas
city: Houston
country: United States
facility: Van Tran Family Practice
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital - Clinical Research Center
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Services
state: Texas
city: Houston
country: United States
facility: DM Clinical Research
state: Texas
city: Houston
country: United States
facility: Pediatric Associates
state: Texas
city: Plano
country: United States
facility: ACRC Trials (Administrative Site)
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Midlothian
country: United States
facility: Virginia Research Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Salvador
country: Brazil
facility: Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC
state: Bahia
city: Belo Horizonte
country: Brazil
facility: Santa Casa De Misericórdia de Belo Horizonte
state: MG
city: Curitiba
country: Brazil
facility: Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Franci
state: Paraná
city: Natal
country: Brazil
facility: CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda
state: RIO Grande DO Norte
city: Sao Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic
state: Pirkanmaa
city: Oulu
country: Finland
facility: FVR, Oulu Clinic
state: Pohjois-pohjanmaa
city: Helsinki
country: Finland
facility: FVR, Helsinki East Clinic
state: Uusimaa
city: Jarvenpaa
country: Finland
facility: FVR, Järvenpää Clinic
state: Uusimaa
city: Helsinki
country: Finland
facility: FVR, Helsinki East Clinic
state: Varsinais-suomi
city: Espoo
country: Finland
facility: FVR, Espoo Clinic
city: Helsinki
country: Finland
facility: FVR, Helsinki South Clinic
city: Helsinki
country: Finland
facility: MeVac - Meilahti Vaccine Research Center
city: Helsinki
country: Finland
facility: FVR, Helsinki East Clinic
city: Kokkola
country: Finland
facility: FVR, Kokkola Clinic
city: Pori
country: Finland
facility: FVR, Pori Clinic
city: Seinajoki
country: Finland
facility: FVR, Seinäjoki Clinic
city: Tampere
country: Finland
facility: FVR, Tampere Clinic
city: Turku
country: Finland
facility: FVR, Turku Clinic
city: Monterrey
country: Mexico
facility: CHRISTUS - LATAM HUB Center of excellence and innovation S.C.
state: Nuevo LEÓN
city: Merida
country: Mexico
facility: Kohler & Milstein Research S.A. de C.V.
state: Yucatan
city: Merida
country: Mexico
facility: Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion
state: Yucatan
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazón S.C.
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: IN-VIVO Bydgoszcz
city: Krakow
country: Poland
facility: Centrum Badan Klinicznych JCI
city: Lodz
country: Poland
facility: Osrodek Badan Klinicznych Appletreeclinics
city: Lodz
country: Poland
facility: GRAVITA Diagnostyka i Leczenie nieplodnosci
city: Lubon
country: Poland
facility: Rodzinne Centrum Medyczne LUBMED
city: Siemianowice Slaskie
country: Poland
facility: Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
city: Warszawa
country: Poland
facility: Provita 001
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario
state: A Coruna
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario Santiago de Compostela
state: A Coruña
city: Centelles
country: Spain
facility: EAP Centelles
state: Barcelona
city: Centelles
country: Spain
facility: EBA Centelles
state: Barcelona
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Barcelona
city: Esplugues De Llobregrat
country: Spain
facility: Hospital Sant Joan de Deu
state: Barcelona
city: Sant Cugat del Valles
country: Spain
facility: Hospital Universitari General de Catalunya
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario HM Puerta del Sur
state: Madrid, Comunidad DE
city: Boadilla del Monte
country: Spain
facility: Hospital Universitario HM Monteprincipe
state: Madrid
city: Antequera
country: Spain
facility: Hospital de Antequera
state: Malaga
city: Antequera
country: Spain
facility: Hospital de Antequera
state: Málaga
city: Malaga
country: Spain
facility: Grupo Pediatrico Uncibay
state: Málaga
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Mostoles
country: Spain
facility: Hospital HM Puerta del Sur
city: Sevilla
country: Spain
facility: Instituto Hispalense de Pediatria
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.