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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816643
• Other study ID #: C4591007
• Secondary ID: 2020-005442-42
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 24, 2021
• Est. completion date: December 8, 2023

Study information

• Verified date: December 2023
• Source: BioNTech SE
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 11837
• Est. completion date: December 8, 2023
• Est. primary completion date: October 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection, COVID-19

Intervention

Biological:
• Biological/Vaccine: BNT162b2 10mcg
BNT162b2 Low/Mid-Dose (10mcg) level
• BNT162b2 20mcg
BNT162b2 Mid-Dose (20mcg) level
• BNT162b2 30mcg
BNT162b2 High-Dose (30mcg) level

Other:
• Placebo
Intramuscular injection

Biological:
• Biological/Vaccine: BNT162b2 3mcg
BNT162b2 Low-Dose (3mcg) level

Locations

Country	Name	City	State
Brazil	Santa Casa De Misericórdia de Belo Horizonte	Belo Horizonte	MG
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	Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC	Salvador	Bahia
Brazil	CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.	Sao Paulo
Finland	FVR, Espoo Clinic	Espoo
Finland	FVR, Helsinki East Clinic	Helsinki	Uusimaa
Finland	FVR, Helsinki East Clinic	Helsinki
Finland	FVR, Helsinki East Clinic	Helsinki	Varsinais-suomi
Finland	FVR, Helsinki South Clinic	Helsinki
Finland	MeVac - Meilahti Vaccine Research Center	Helsinki
Finland	FVR, Järvenpää Clinic	Jarvenpaa	Uusimaa
Finland	FVR, Kokkola Clinic	Kokkola
Finland	FVR, Oulu Clinic	Oulu	Pohjois-pohjanmaa
Finland	FVR, Pori Clinic	Pori
Finland	FVR, Seinäjoki Clinic	Seinajoki
Finland	FVR, Tampere Clinic	Tampere
Finland	Tampere Vaccine Research Clinic	Tampere	Pirkanmaa
Finland	FVR, Turku Clinic	Turku
Mexico	Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion	Merida	Yucatan
Mexico	Kohler & Milstein Research S.A. de C.V.	Merida	Yucatan
Mexico	CHRISTUS - LATAM HUB Center of excellence and innovation S.C.	Monterrey	Nuevo LEÓN
Mexico	Sociedad de Metabolismo y Corazón S.C.	Veracruz
Poland	IN-VIVO Bydgoszcz	Bydgoszcz
Poland	Centrum Badan Klinicznych JCI	Krakow
Poland	GRAVITA Diagnostyka i Leczenie nieplodnosci	Lodz
Poland	Osrodek Badan Klinicznych Appletreeclinics	Lodz
Poland	Rodzinne Centrum Medyczne LUBMED	Lubon
Poland	Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska	Siemianowice Slaskie
Poland	MICS Centrum Medyczne Torun	Torun	Kujawsko-pomorskie
Poland	Provita 001	Warszawa
Spain	Hospital de Antequera	Antequera	Malaga
Spain	Hospital de Antequera	Antequera	Málaga
Spain	Hospital Universitario HM Monteprincipe	Boadilla del Monte	Madrid
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 Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario HM Puerta del Sur	Madrid	Madrid, Comunidad DE
Spain	Grupo Pediatrico Uncibay	Malaga	Málaga
Spain	Hospital HM Puerta del Sur	Mostoles
Spain	Hospital Universitari General de Catalunya	Sant Cugat del Valles	Barcelona
Spain	CHUS - Hospital Clinico Universitario	Santiago de Compostela	A Coruna
Spain	Hospital Clinico Universitario Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Instituto Hispalense de Pediatria	Sevilla
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Emory Children's Center Illness POD	Atlanta	Georgia
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	ARC Clinical Research at Four Points	Austin	Texas
United States	ARC Clinical Research at Wilson Parke	Austin	Texas
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Kentucky Pediatric/ Adult Research	Bardstown	Kentucky
United States	Michigan Center of Medical Research	Bingham Farms	Michigan
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	University of Alabama at Birmingham - School of Medicine	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Coastal Pediatric Research	Charleston	South Carolina
United States	Atrium Health-STRIVE Vaccine Research Clinic	Charlotte	North Carolina
United States	Teen Health Connection (study visits)	Charlotte	North Carolina
United States	Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)	Charlottesville	Virginia
United States	Pediatric Research of Charlottesville, LLC	Charlottesville	Virginia
United States	Clinical Research Professionals	Chesterfield	Missouri
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	Advanced Specialty Care	Commack	New York
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	Cedar Health Research	Dallas	Texas
United States	PriMed Clinical Research	Dayton	Ohio
United States	PriMed Clinical Research	Dayton	Ohio
United States	Bay Colony Pediatrics	Dickinson	Texas
United States	Duke University - Main Hospital and Clinics	Durham	North Carolina
United States	Duke Vaccine And Trials Unit	Durham	North Carolina
United States	Velocity Clinical Research-Providence	East Greenwich	Rhode Island
United States	Clinical Research Center	East Setauket	New York
United States	Proactive Clinical Research, LLC	Edinburg	Texas
United States	AHN Erie Health + Wellness Pavillion: West	Erie	Pennsylvania
United States	Village Health Partners (Patient Seen Address)	Frisco	Texas
United States	Tribe Clinical Research, LLC	Greenville	South Carolina
United States	Cyn3rgy Research	Gresham	Oregon
United States	Meridian Clinical Research, LLC	Hastings	Nebraska
United States	DM Clinical Research	Houston	Texas
United States	Helios Clinical Research - HOU	Houston	Texas
United States	Pediatric Associates	Houston	Texas
United States	Texas Children's Hospital - Clinical Research Center	Houston	Texas
United States	Van Tran Family Practice	Houston	Texas
United States	West Houston Clinical Research Services	Houston	Texas
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Velocity Clinical Research, Lincoln	Lincoln	Nebraska
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Matrix Clinical Research	Los Angeles	California
United States	SCPMG/Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Novak Center for Children's Health	Louisville	Kentucky
United States	Meridian Clinical Research, LLC	Macon	Georgia
United States	Madera Family Medical Group	Madera	California
United States	Atrium Health-STRIVE Vaccine Research Clinic (study visits)	Matthews	North Carolina
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Solaris Clinical Research	Meridian	Idaho
United States	Acevedo Clinical Research Associates	Miami	Florida
United States	Virginia Research Center	Midlothian	Virginia
United States	Clinical Research Associates Inc	Nashville	Tennessee
United States	Rutgers University	New Brunswick	New Jersey
United States	Yale Center for Clinical Investigation	New Haven	Connecticut
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Alliance for Multispecialty Research, LLC	Newton	Kansas
United States	Kaiser Permanente Oakland	Oakland	California
United States	Children's Hospital & Medical Center	Omaha	Nebraska
United States	Children's Physician's Clinic, Spring Valley	Omaha	Nebraska
United States	Clinical Neuroscience Solutions	Orlando	Florida
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	Paramount	California
United States	Center for Clinical Trials, LLC	Paramount	California
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	ACRC Trials (Administrative Site)	Plano	Texas
United States	Quinn Healthcare/SKYCRNG	Ridgeland	Mississippi
United States	SKY Integrative Medical Center/SKYCRNG	Ridgeland	Mississippi
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	Peninsula Research Associates	Rolling Hills Estates	California
United States	Kaiser Permanente Sacramento	Sacramento	California
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	Kaiser Permanente Santa Clara	Santa Clara	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	Louisiana State University Health Sciences Shreveport	Shreveport	Louisiana
United States	Senders Pediatrics	South Euclid	Ohio
United States	Stanford Health Care	Stanford	California
United States	Stanford Health Care Investigational Drug Service	Stanford	California
United States	Stony Brook University	Stony Brook	New York
United States	Coastal Pediatric Research	Summerville	South Carolina
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Rophe Adult and Pediatric Medicine/SKYCRNG	Union City	Georgia
United States	Bayview Research Group, LLC	Valley Village	California
United States	Children's National Medical Center	Washington	District of Columbia
United States	Emerson Clinical Research Institute	Washington	District of Columbia
United States	Emerson Clinical Research Institute - Washington - Connecticut Avenue	Washington	District of Columbia
United States	Meridian Clinical Research, LLC	Washington	District of Columbia
United States	Alliance for Multispecialty Research, LLC	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
BioNTech SE	Pfizer

Countries where clinical trial is conducted

United States,  Brazil,  Finland,  Mexico,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants in Phase 1 reporting local reactions	Pain or tenderness at the injection site, redness and swelling as reported on electronic diaries.	for 7 days after Dose 1 and Dose 2
Primary	Percentage of participants in Phase 1 reporting systemic events	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	for 7 days after Dose 1 and Dose 2
Primary	Percentage of participants in Phase 1 reporting adverse events	As elicited by investigational site staff	from Dose 1 through 1 month after the last dose
Primary	Percentage of participants in Phase 1 reporting serious adverse events	As elicited by investigational site staff	from Dose 1 through 6 months after the last dose
Primary	Percentage of participants in Phase 2/3 reporting local reaction	Pain or tenderness at the injection site, redness and swelling as reported on electronic diaries.	for 7 days after Dose 1 and Dose 2
Primary	Percentage of participants in Phase 2/3 reporting systemic events	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	for 7 days after Dose 1 and Dose 2
Primary	Percentage of participants in Phase 2/3 reporting adverse events	As elicited by investigational site staff	from Dose 1 through 1 month after the last dose
Primary	Percentage of participants in Phase 2/3 reporting serious adverse events	As elicited by investigational site staff	from Dose 1 through 6 months after the last dose
Primary	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	As measured at the central laboratory	1 month after the second dose
Primary	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	As measured at the central laboratory	1 month after the second dose
Primary	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	As measured at the central laboratory	1 month after the second dose
Primary	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	As measured at the central laboratory	1 month after the second dose
Primary	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	As measured at the central laboratory	1 month after the second dose
Primary	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	As measured at the central laboratory	1 month after the second dose
Primary	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	As measured at the central laboratory	1 month after the third dose
Primary	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	As measured at the central laboratory	1 month after the third dose
Primary	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	As measured at the central laboratory	1 month after the third dose
Primary	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	As measured at the central laboratory	1 month after the third dose
Secondary	In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs	As measured at the central laboratory	At each time point
Secondary	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	As measured at the central laboratory	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
Secondary	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	As measured at the central laboratory	From before Dose 1 to each subsequent time point after Dose 2
Secondary	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	Per 1000 person-years of follow-up	From 7 days after the second dose to prior to third dose
Secondary	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	Per 1000 person-years of follow-up	From 7 days after the second dose to prior to third dose
Secondary	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	1000 person-years of follow-up	From 7 days after the third dose
Secondary	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	1000 person-years of follow-up	From 7 days after the third dose

External Links

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