Purpose

This is a Phase 1/2/3 study in healthy children and young adults. 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.

Condition

Eligibility

Eligible Ages
Between 6 Months and 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 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. 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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low/Mid-Dose, ≥5 to <12 Years
Low/Mid-Dose (10mcg), 2 doses 21 days apart
  • Biological: Biological/Vaccine: BNT162b2 10mcg
    BNT162b2 Low/Mid-Dose (10mcg) level
Experimental
Mid-Dose, ≥5 to <12 Years
Mid-Dose, (20mcg), 2 doses 21 days apart
  • Biological: BNT162b2 20mcg
    BNT162b2 Mid-Dose (20mcg) level
Experimental
High-Dose, ≥5 to <12 Years
High-Dose (30mcg), 2 doses 21 days apart
  • Biological: BNT162b2 30mcg
    BNT162b2 High-Dose (30mcg) level
Experimental
Low/Mid-Dose, ≥2 to < 5 Years
Low/Mid-Dose (10mcg), 2 doses 21 days apart
  • Biological: Biological/Vaccine: BNT162b2 10mcg
    BNT162b2 Low/Mid-Dose (10mcg) level
Experimental
Mid-Dose, ≥2 to <5 Years
Mid-Dose, (20mcg), 2 doses 21 days apart
  • Biological: BNT162b2 20mcg
    BNT162b2 Mid-Dose (20mcg) level
Experimental
High-Dose, ≥2 to <5 Years
High-Dose, (30mcg), 2 doses 21 days apart
  • Biological: BNT162b2 30mcg
    BNT162b2 High-Dose (30mcg) level
Experimental
Low/Mid-Dose, ≥6 Months to <2 Years
Low/Mid-Dose, (10mcg), 2 doses 21 days apart
  • Biological: Biological/Vaccine: BNT162b2 10mcg
    BNT162b2 Low/Mid-Dose (10mcg) level
Experimental
Mid-Dose, ≥6 Months to <2 Years
Mid-Dose, (20mcg), 2 doses 21 days apart
  • Biological: BNT162b2 20mcg
    BNT162b2 Mid-Dose (20mcg) level
Experimental
High-Dose, ≥6 Months to <2 Years
High-Dose, (30mcg), 2 doses 21 days apart
  • Biological: BNT162b2 30mcg
    BNT162b2 High-Dose (30mcg) level
Experimental
Low/Mid-Dose, 16 to <18 Years (21 day schedule)
Low/Mid-Dose (10mcg), 2 doses 21 days apart
  • Biological: Biological/Vaccine: BNT162b2 10mcg
    BNT162b2 Low/Mid-Dose (10mcg) level
Placebo Comparator
Placebo, ≥6 Months to <2 Years
  • Other: Placebo
    Intramuscular injection
Placebo Comparator
Placebo, ≥2 to <5 Years
  • Other: Placebo
    Intramuscular injection
Placebo Comparator
Placebo, ≥5 to <12 Years
  • Other: Placebo
    Intramuscular injection
Experimental
Low-Dose, ≥6 Months to <2 Years
Low-Dose (3mcg), 2 doses 21 doses apart
  • Biological: Biological/Vaccine: BNT162b2 3mcg
    BNT162b2 Low-Dose (3mcg) level
Experimental
Low-Dose, ≥2 to <5 Years
Low-Dose (3mcg), 2 doses 21 days apart
  • Biological: Biological/Vaccine: BNT162b2 3mcg
    BNT162b2 Low-Dose (3mcg) level
Experimental
Low/Mid-Dose, 12 to <16 Years (21 day schedule)
Low/Mid-Dose (10mcg), 2 doses 21 days apart
  • Biological: Biological/Vaccine: BNT162b2 10mcg
    BNT162b2 Low/Mid-Dose (10mcg) level
Experimental
High-Dose, 12 to <16 Years (Troponin I Testing)
High-Dose (30mcg), 2 doses 21 days apart
  • Biological: BNT162b2 30mcg
    BNT162b2 High-Dose (30mcg) level
Experimental
Low/Mid-Dose, ≥5 to <12 Years (Troponin I Testing)
Low/Mid-Dose (10mcg), 2 doses 21 days apart. A separate cohort of participants to collect serum samples for potential troponin I testing
  • Biological: Biological/Vaccine: BNT162b2 10mcg
    BNT162b2 Low/Mid-Dose (10mcg) level
Experimental
Placebo, ≥5 to <12 Years (Troponin I Testing)
A separate cohort of participants to collect serum samples for potential troponin I testing
  • Other: Placebo
    Intramuscular injection
Experimental
Low/Mid-Dose, 12 to <16 Years (8 week schedule)
Low/Mid-Dose (10mcg), 2 doses 8 weeks apart
  • Biological: Biological/Vaccine: BNT162b2 10mcg
    BNT162b2 Low/Mid-Dose (10mcg) level
Experimental
Low/Mid-Dose, 16 to <18 Years (8 week schedule)
Low/Mid-Dose (10mcg), 2 doses 8 weeks apart
  • Biological: Biological/Vaccine: BNT162b2 10mcg
    BNT162b2 Low/Mid-Dose (10mcg) level
Experimental
Low-Dose, ≥6 Months to <2 Years (3-dose regimen)
Low-Dose (3mcg), 3 doses
  • Biological: Biological/Vaccine: BNT162b2 3mcg
    BNT162b2 Low-Dose (3mcg) level
Experimental
Low-Dose, ≥2 to <5 Years (3-dose regimen)
Low-Dose (3mcg), 3 doses
  • Biological: Biological/Vaccine: BNT162b2 3mcg
    BNT162b2 Low-Dose (3mcg) level
Placebo Comparator
Placebo, ≥6 Months to <2 Years (3-dose regimen)
  • Other: Placebo
    Intramuscular injection
Placebo Comparator
Placebo, ≥2 to <5 Years (3-dose regimen)
  • Other: Placebo
    Intramuscular injection

Recruiting Locations

Children's National and nearby locations

Children's National Medical Center
Washington, District of Columbia 20010

More Details

NCT ID
NCT04816643
Status
Recruiting
Sponsor
BioNTech SE

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

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 1 Lower-Dose Evaluation Is the open-label lower-dose evaluation portion of the study that will evaluate the safety, tolerability, and immunogenicity of 10 µg BNT162b2 from 2 schedules in 2 age groups (participants 12 to <16 years and 16 to <18 years of age). The purpose of the Phase 1 lower-dose evaluation is to evaluate the safety and immunogenicity of BNT162b2 from 2 different dose schedules in each age group: (1) 2 doses separated by approximately 21 days and (2) 2 doses separated by approximately 8 weeks. Participants will have blood drawn prior to Dose 1, prior to Dose 2, 7 days after Dose 2, and 1 month after Dose 2 to assess immunogenicity to determine the selected BNT162b2 dose schedule for the Phase 2/3 lower-dose evaluation portion of the study. In addition, participants will have blood drawn at 6 and 12 months after Dose 2 to determine the persistence of the immune response. 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 Lower-Dose Evaluation Is the open-label portion of the study that will evaluate the safety, tolerability, and immunogenicity of the selected dose schedule in each age group from the Phase 1 lower-dose evaluation, with a total of approximately 600 active participants. Approximately 300 active participants in each age group in this phase will contribute to the immunobridging analysis at 1 month after Dose 2 and the overall analysis of the persistence of immune response at 6 and 12 months after Dose 2. 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: 750 participants randomized 2:1 to receive BNT162b2 10 µg or placebo, and 500 participants 12 to <16 years of age: open-label receipt of BNT162b2 30 µg.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.