A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children and Young Adults

• ClinicalTrials.gov Identifier: NCT04816643
• Recruitment Status: Active, not recruiting
• First Posted: March 25, 2021
• Last Update Posted: May 23, 2023
• Sponsor: BioNTech SE
• Collaborator: Pfizer
• Information provided by (Responsible Party): BioNTech SE

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
SARS-CoV-2 Infection, COVID-19	Biological: Biological/Vaccine: BNT162b2 10mcg; Biological: BNT162b2 20mcg; Biological: BNT162b2 30mcg; Other: Placebo; Biological: Biological/Vaccine: BNT162b2 3mcg	Phase 2; Phase 3

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: 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11109 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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 AND YOUNG ADULTS
• Actual Study Start Date: March 24, 2021
• Estimated Primary Completion Date: October 17, 2023
• Estimated Study Completion Date: October 17, 2023

Arms and Interventions

Arm	Intervention/treatment
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), 3 doses	Biological: BNT162b2 30mcg; BNT162b2 High-Dose (30mcg) level
Experimental: Low/Mid-Dose, ≥5 to <12 Years (Troponin I Testing); Low/Mid-Dose (10mcg), 3 doses	Biological: Biological/Vaccine: BNT162b2 10mcg; BNT162b2 Low/Mid-Dose (10mcg) level
Experimental: Placebo, ≥5 to <12 Years (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

Outcome Measures

Primary Outcome Measures :

1. Percentage of participants in Phase 1 reporting local reactions [ Time Frame: for 7 days after Dose 1 and Dose 2 ]
   Pain or tenderness at the injection site, redness and swelling as reported on electronic diaries.
2. Percentage of participants in Phase 1 reporting systemic events [ Time Frame: for 7 days after Dose 1 and Dose 2 ]
   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
3. Percentage of participants in Phase 1 reporting adverse events [ Time Frame: from Dose 1 through 1 month after the last dose ]
   As elicited by investigational site staff
4. Percentage of participants in Phase 1 reporting serious adverse events [ Time Frame: from Dose 1 through 6 months after the last dose ]
   As elicited by investigational site staff
5. Percentage of participants in Phase 2/3 reporting local reaction [ Time Frame: for 7 days after Dose 1 and Dose 2 ]
   Pain or tenderness at the injection site, redness and swelling as reported on electronic diaries.
6. Percentage of participants in Phase 2/3 reporting systemic events [ Time Frame: for 7 days after Dose 1 and Dose 2 ]
   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
7. Percentage of participants in Phase 2/3 reporting adverse events [ Time Frame: from Dose 1 through 1 month after the last dose ]
   As elicited by investigational site staff
8. Percentage of participants in Phase 2/3 reporting serious adverse events [ Time Frame: from Dose 1 through 6 months after the last dose ]
   As elicited by investigational site staff
9. 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 [ Time Frame: 1 month after the second dose ]
   As measured at the central laboratory
10. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory
11. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory
12. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory
13. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory
14. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory
15. 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 [ Time Frame: 1 month after the third dose ]
    As measured at the central laboratory
16. 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 [ Time Frame: 1 month after the third dose ]
    As measured at the central laboratory
17. 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 [ Time Frame: 1 month after the third dose ]
    As measured at the central laboratory
18. 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 [ Time Frame: 1 month after the third dose ]
    As measured at the central laboratory

Secondary Outcome Measures :

1. In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: At each time point ]
   As measured at the central laboratory
2. 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 [ Time Frame: 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 ]
   As measured at the central laboratory
3. 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 [ Time Frame: From before Dose 1 to each subsequent time point after Dose 2 ]
   As measured at the central laboratory
4. In the evaluable Phase 2/3 selected-dose participants, Ratio of incidence of asymptomatic SARS-CoV-2 infection based on N-binding antibody seroconversion for the active vaccine group to the placebo group without evidence of past SARS-CoV-2 infection [ Time Frame: Through 6 months after the second dose ]
   As measured at the central laboratory
5. Ph 2/3 LDE participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants 12 to <16 years of age to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years of age in the C4591001 study [ Time Frame: 1 month after the second dose ]
   As measured at the central laboratory
6. Ph 2/3 LDE participants, immunobridging of SARS-CoV-2 serum neutralizing titers in participants 16 to <18 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 55 years from Phase 2/3 of the C4591001 study [ Time Frame: 1 month after the second dose ]
   As measured at the central laboratory
7. In Phase 2/3 lower-dose evaluation participants, the difference in percentages of participants with seroresponse in participants 12 to <16 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study [ Time Frame: 1 month after the second dose ]
   As measured at the central laboratory
8. In lower-dose evaluation participants, the difference in percentages of participants with seroresponse in participants 16 to <18 years of age and participants 16 to 55 years of age from C4591001 study [ Time Frame: 1 month after the second dose ]
   As measured at the central laboratory
9. 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 [ Time Frame: From 7 days after the second dose to prior to third dose ]
   Per 1000 person-years of follow-up
10. 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 [ Time Frame: From 7 days after the second dose to prior to third dose ]
    Per 1000 person-years of follow-up
11. 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 [ Time Frame: From 7 days after the third dose ]
    1000 person-years of follow-up
12. 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 [ Time Frame: From 7 days after the third dose ]
    1000 person-years of follow-up

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama, United States, 35233

United States, Arizona

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

United States, California

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States, 90027

SCPMG/Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States, 90027

Matrix Clinical Research

Los Angeles, California, United States, 90057

Madera Family Medical Group

Madera, California, United States, 93637

Kaiser Permanente Oakland

Oakland, California, United States, 94611

Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University

Palo Alto, California, United States, 94304

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States, 94304

Center for Clinical Trials, LLC

Paramount, California, United States, 90723

Center for Clinical Trials

Paramount, California, United States, 90723

Peninsula Research Associates

Rolling Hills Estates, California, United States, 90274

Kaiser Permanente Sacramento

Sacramento, California, United States, 95815

Kaiser Permanente Santa Clara

Santa Clara, California, United States, 95051

Stanford Health Care Investigational Drug Service

Stanford, California, United States, 94305

Stanford Health Care

Stanford, California, United States, 94305

Bayview Research Group, LLC

Valley Village, California, United States, 91607

United States, Colorado

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

United States, Connecticut

Yale Center for Clinical Investigation

New Haven, Connecticut, United States, 06519

United States, District of Columbia

Children's National Medical Center

Washington, District of Columbia, United States, 20010

Emerson Clinical Research Institute

Washington, District of Columbia, United States, 20011

Meridian Clinical Research, LLC

Washington, District of Columbia, United States, 20016

United States, Florida

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States, 32256

Acevedo Clinical Research Associates

Miami, Florida, United States, 33142

Clinical Neuroscience Solutions

Orlando, Florida, United States, 32801

United States, Georgia

Emory Children's Center Illness POD

Atlanta, Georgia, United States, 30322

Emory University School of Medicine

Atlanta, Georgia, United States, 30322

Atlanta Center for Medical Research

Atlanta, Georgia, United States, 30331

Meridian Clinical Research, LLC

Macon, Georgia, United States, 31210

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States, 30291

United States, Idaho

Clinical Research Prime

Idaho Falls, Idaho, United States, 83404

Solaris Clinical Research

Meridian, Idaho, United States, 83646

United States, Kansas

Alliance for Multispecialty Research, LLC

Newton, Kansas, United States, 67114

Alliance for Multispecialty Research, LLC

Wichita, Kansas, United States, 67207

United States, Kentucky

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, United States, 40004

Novak Center for Children's Health

Louisville, Kentucky, United States, 40202

United States, Louisiana

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, United States, 71101

United States, Maryland

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States, 21224

United States, Massachusetts

Boston Medical Center

Boston, Massachusetts, United States, 02118

United States, Michigan

Michigan Center of Medical Research

Bingham Farms, Michigan, United States, 48025

United States, Mississippi

Quinn Healthcare/SKYCRNG

Ridgeland, Mississippi, United States, 39157

United States, Missouri

Clinical Research Professionals

Chesterfield, Missouri, United States, 63005

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

United States, Nebraska

Meridian Clinical Research, LLC

Hastings, Nebraska, United States, 68901

Meridian Clinical Research, LLC

Lincoln, Nebraska, United States, 68510

Children's Hospital & Medical Center

Omaha, Nebraska, United States, 68114

Children's Physician's Clinic, Spring Valley

Omaha, Nebraska, United States, 68117

United States, New Jersey

Rutgers University

New Brunswick, New Jersey, United States, 08903

United States, New York

Meridian Clinical Research LLC

Binghamton, New York, United States, 13901

Meridian Clinical Research, LLC

Binghamton, New York, United States, 13901

Meridian Clinical Research LLC

Binghamton, New York, United States, 13905

Advanced Specialty Care

Commack, New York, United States, 11725

Clinical Research Center

East Setauket, New York, United States, 11733

Rochester Clinical Research, Inc.

Rochester, New York, United States, 14609

University of Rochester Medical Center

Rochester, New York, United States, 14642

Stony Brook University

Stony Brook, New York, United States, 11794

SUNY Upstate Medical University

Syracuse, New York, United States, 13210

United States, North Carolina

Atrium Health-STRIVE Vaccine Research Clinic

Charlotte, North Carolina, United States, 28207

Teen Health Connection (study visits)

Charlotte, North Carolina, United States, 28211

Duke Vaccine and Trials Unit

Durham, North Carolina, United States, 27703

Atrium Health-STRIVE Vaccine Research Clinic (study visits)

Matthews, North Carolina, United States, 28105

United States, Ohio

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45206

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Aventiv Research Inc.

Columbus, Ohio, United States, 43213

PriMed Clinical Research

Dayton, Ohio, United States, 45419

PriMed Clinical Research

Dayton, Ohio, United States, 45429

Senders Pediatrics

South Euclid, Ohio, United States, 44121

United States, Oregon

Cyn3rgy Research

Gresham, Oregon, United States, 97030

United States, Pennsylvania

AHN Erie Health + Wellness Pavillion: West

Erie, Pennsylvania, United States, 16506

United States, Rhode Island

Velocity Clinical Research-Providence

East Greenwich, Rhode Island, United States, 02818

United States, South Carolina

Coastal Pediatric Research

Charleston, South Carolina, United States, 29414

Tribe Clinical Research, LLC

Greenville, South Carolina, United States, 29607

Coastal Pediatric Research

Summerville, South Carolina, United States, 29486

United States, Tennessee

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Clinical Research Associates Inc

Nashville, Tennessee, United States, 37203

United States, Texas

ARC Clinical Research at Four Points

Austin, Texas, United States, 78726

ARC Clinical Research at Wilson Parke

Austin, Texas, United States, 78726

Driscoll Children's Hospital

Corpus Christi, Texas, United States, 78411

Cedar Health Research

Dallas, Texas, United States, 75251

Bay Colony Pediatrics

Dickinson, Texas, United States, 77539

Proactive Clinical Research, LLC

Edinburg, Texas, United States, 78539

Village Health Partners (Patient Seen Address)

Frisco, Texas, United States, 75033

Helios Clinical Research - HOU

Houston, Texas, United States, 77008

Van Tran Family Practice

Houston, Texas, United States, 77008

Texas Children's Hospital - Clinical Research Center

Houston, Texas, United States, 77030

West Houston Clinical Research Services

Houston, Texas, United States, 77055

DM Clinical Research

Houston, Texas, United States, 77065

Pediatric Associates

Houston, Texas, United States, 77087

ACRC Trials (Administrative Site)

Plano, Texas, United States, 75024

United States, Utah

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States, 84109

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, United States, 84121

United States, Virginia

Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)

Charlottesville, Virginia, United States, 22902

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, United States, 22902

Virginia Research Center

Midlothian, Virginia, United States, 23114

United States, Washington

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Brazil

Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC

Salvador, Bahia, Brazil, 40415-006

Santa Casa De Misericórdia de Belo Horizonte

Belo Horizonte, MG, Brazil, 30150-221

Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Franci

Curitiba, Paraná, Brazil, 80810-050

CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda

Natal, RIO Grande DO Norte, Brazil, 59025-050

CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.

Sao Paulo, Brazil, 04266-010

Finland

FVR, Tampere Clinic

Tampere, Pirkanmaa, Finland, 33100

FVR, Oulu Clinic

Oulu, Pohjois-pohjanmaa, Finland, 90220

FVR, Helsinki East Clinic

Helsinki, Uusimaa, Finland, 00930

FVR, Järvenpää Clinic

Jarvenpaa, Uusimaa, Finland, 04400

FVR, Helsinki East Clinic

Helsinki, Varsinais-suomi, Finland, 00930

FVR, Espoo Clinic

Espoo, Finland, 02230

FVR, Helsinki South Clinic

Helsinki, Finland, 00100

MeVac - Meilahti Vaccine Research Center

Helsinki, Finland, 00290

FVR, Helsinki East Clinic

Helsinki, Finland, 00930

FVR, Kokkola Clinic

Kokkola, Finland, 67100

FVR, Pori Clinic

Pori, Finland, 28100

FVR, Seinäjoki Clinic

Seinajoki, Finland, 60100

FVR, Turku Clinic

Turku, Finland, 20520

Mexico

CHRISTUS - LATAM HUB Center of excellence and innovation S.C.

Monterrey, Nuevo LEÓN, Mexico, C.P. 64060

Kohler & Milstein Research S.A. de C.V.

Merida, Yucatan, Mexico, 97070

Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion

Merida, Yucatan, Mexico, 97130

Sociedad de Metabolismo y Corazón S.C.

Veracruz, Mexico, C.P. 91900

Poland

MICS Centrum Medyczne Torun

Torun, Kujawsko-pomorskie, Poland, 87-100

IN-VIVO Bydgoszcz

Bydgoszcz, Poland, 85-048

Centrum Badan Klinicznych JCI

Krakow, Poland, 30-348

Osrodek Badan Klinicznych Appletreeclinics

Lodz, Poland, 90-349

GRAVITA Diagnostyka i Leczenie nieplodnosci

Lodz, Poland, 91-347

Rodzinne Centrum Medyczne LUBMED

Lubon, Poland, 62-030

Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska

Siemianowice Slaskie, Poland, 41-103

Provita 001

Warszawa, Poland, 02-647

Spain

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruna, Spain, 15706

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, A Coruña, Spain, 15706

EAP Centelles

Centelles, Barcelona, Spain, 08540

EBA Centelles

Centelles, Barcelona, Spain, 08540

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, Spain, 08950

Hospital Sant Joan de Deu

Esplugues De Llobregrat, Barcelona, Spain, 08950

Hospital Universitari General de Catalunya

Sant Cugat del Valles, Barcelona, Spain, 08195

Hospital Universitario HM Puerta del Sur

Madrid, Madrid, Comunidad DE, Spain, 28938

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, Spain, 28660

Hospital de Antequera

Antequera, Malaga, Spain, 29200

Hospital de Antequera

Antequera, Málaga, Spain, 29200

Grupo Pediatrico Uncibay

Malaga, Málaga, Spain, 29015

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Hospital HM Puerta del Sur

Mostoles, Spain, 28938

Instituto Hispalense de Pediatria

Sevilla, Spain, 41012

Sponsors and Collaborators

BioNTech SE

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: BioNTech SE
• ClinicalTrials.gov Identifier: NCT04816643
• Other Study ID Numbers: C4591007; 2020-005442-42 ( EudraCT Number )
• First Posted: March 25, 2021
• Last Update Posted: May 23, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BioNTech SE:

COVID-19; Coronavirus Vaccine; SARS-CoV-2; RNA Vaccine; mRNA Vaccine

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs