Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults

• ClinicalTrials.gov Identifier: NCT04588480
• Recruitment Status: Completed
• First Posted: October 19, 2020
• Results First Posted: February 1, 2023
• Last Update Posted: February 1, 2023
• Sponsor: BioNTech SE
• Collaborator: Pfizer
• Information provided by (Responsible Party): BioNTech SE

Tracking Information

• First Submitted Date: October 14, 2020
• First Posted Date: October 19, 2020
• Results First Submitted Date: November 23, 2022
• Results First Posted Date: February 1, 2023
• Last Update Posted Date: February 1, 2023
• Actual Study Start Date: October 21, 2020
• Actual Primary Completion Date: November 25, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 13, 2023)

• Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 [ Time Frame: Within 7 days after Dose 1 ]
  Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (>) 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Events were classified as Grade 4 based on study investigator's judgement. Maximum severity was the highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.
• Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2 [ Time Frame: Within 7 days after Dose 2 ]
  Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: > 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Events were classified as Grade 4 based on study investigator's judgement. Maximum severity was the highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.
• Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1 [ Time Frame: Within 7 days after Dose 1 ]
  Systemic events were recorded by participants in e-diary. Fever was categorized as greater than or equal to (>=)37.5 to 38.4 degrees(deg) Celsius(C), >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Events were classified as Grade 4 potentially life threatening (emergency room visit or hospitalization) based on study investigator's judgement. Maximum severity=highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.
• Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2 [ Time Frame: Within 7 days after Dose 2 ]
  Systemic events were recorded by participants in an e-diary. Fever was categorized as >= 37.5 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Events were classified as Grade 4 potentially life threatening (emergency room visit or hospitalization) based on study investigator's judgement. Maximum severity=highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.
• Percentage of Participants With Adverse Events (AEs) From Dose 1 up to 1 Month After Dose 2 [ Time Frame: Dose 1 up to 1 month after Dose 2 ]
  An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with AEs and the associated 95% confidence interval (CI) based on the Clopper and Pearson method was presented. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
• Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 up to 12 Months After Dose 2 [ Time Frame: Dose 1 up to 12 months after Dose 2 ]
  SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or considered an important medical event. Percentage of participants with SAEs and the associated 95% CI based on the Clopper and Pearson method was presented.
• Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 1 Day After Dose 1 by Age Category [ Time Frame: Within 1 day after Dose 1 ]
  The pre-defined criteria for laboratory parameters included: hemoglobin (HGB), hematocrit, erythrocytes(ery.) less than (<)0.8* lower limit of normal (LLN); ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration <0.9*LLN and >1.1*upper limit of normal (ULN); platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes, neutrophils <0.8*LLN and >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN; urea nitrogen, creatinine >1.3*ULN. Percentage of participants with abnormal hematology and chemistry laboratory values by age categories 20 to 64 years and 65 to 85 years were reported in this outcome measure. Categories with at least 1 non-zero data values were reported.
• Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 7 Days After Dose 1 by Age Category [ Time Frame: Within 7 days after Dose 1 ]
  The pre-defined criteria for laboratory parameters included: HGB, hematocrit, ery. <0.8* LLN; ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration <0.9*LLN and >1.1*ULN; platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes, neutrophils <0.8*LLN and >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN; urea nitrogen, creatinine >1.3*ULN. Percentage of participants with abnormal hematology and chemistry laboratory values by age categories 20 to 64 years and 65 to 85 years were reported in this outcome measure. Categories with at least 1 non-zero data values were reported.
• Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 7 Days After Dose 2 by Age Category [ Time Frame: Within 7 days after Dose 2 ]
  The pre-defined criteria for laboratory parameters included: HGB, hematocrit, ery. <0.8* LLN; ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration <0.9*LLN and >1.1*ULN; platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes, neutrophils <0.8*LLN and >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN; urea nitrogen, creatinine >1.3*ULN. Categories with at least 1 non-zero data value were reported (only 65-85 years: Lymphocytes category was reported).
• Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category [ Time Frame: From baseline (observation prior to Dose 1) up to 1 day after Dose 1 ]
  Hematology parameters: hemoglobin, eosinophils, lymphocytes decrease, neutrophil decrease, platelets decrease, white blood cell (WBC) decrease, WBC increase. Chemistry parameters: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased, creatinine increased, blood urea nitrogen. Laboratory abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology and chemistry laboratory values by age categories (20 to 64 years and 65 to 85 years) were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 day after dose 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
• Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 7 Days After Dose 1 by Age Category [ Time Frame: From baseline (observation prior to Dose 1) up to 7 days after Dose 1 ]
  Hematology parameters included: hemoglobin, eosinophils, lymphocytes decrease, neutrophil decrease, platelets decrease, WBC decrease, WBC increase. Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased, creatinine increased, urea nitrogen. Laboratory abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology and chemistry laboratory values by age categories (20 to 64 years and 65 to 85 years) were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in grade from baseline to 7 days after dose 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
• Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category [ Time Frame: Before Dose 2 up to 7 days after Dose 2 ]
  Hematology parameters included: hemoglobin, eosinophils, lymphocytes decrease, neutrophil decrease, platelets decrease, WBC decrease, WBC increase. Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased, creatinine increased, urea nitrogen. Laboratory abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3= severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology and chemistry laboratory values by age categories (20 to 64 years and 65 to 85 years) were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in grade from before dose 2 to 7 days after dose 2 were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
• Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 2 [ Time Frame: 1 month after Dose 2 ]
  GMT of SARS-CoV-2 neutralizing titer was calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student's t distribution. GMT of SARS-CoV-2 neutralization titer 50% (NT50) was reported in this outcome measure.
• Geometric Mean Fold Rises (GMFRs) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After Dose 2 [ Time Frame: Before vaccination up to 1 month after Dose 2 ]
  GMFR was defined as the result after vaccination divided by the result before vaccination. GMFR and the corresponding 2-sided 95% CIs was calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t distribution). GMFR of SARS-CoV-2 NT50 was reported in this outcome measure.

Original Primary Outcome Measures (submitted: October 14, 2020)

• Percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ]
  Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
• Percentage of participants 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 joint pain as self-reported on electronic diaries.
• Percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ]
  As elicited by investigational site staff
• Percentage of participants reporting serious adverse events [ Time Frame: From dose 1 through 12 months after the last dose ]
  As elicited by investigational site staff
• Percentage of subset participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 day after dose 1 ]
  As measured at the local laboratory
• Percentage of subset participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 1 ]
  As measured at the local laboratory
• Percentage of subset participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 2 ]
  As measured at the local laboratory
• Percentage of subset participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 1 day after dose 1 ]
  As measured at the local laboratory
• Percentage of subset participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 7 days after dose 1 ]
  As measured at the local laboratory
• Percentage of subset participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between before dose 2 and 7 days after dose 2 ]
  As measured at the local laboratory
• SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: 1 month after dose 2 ]
  As measured at the central laboratory
• GMFR in SARS-CoV-2 serum neutralizing titers [ Time Frame: From before vaccination to 1 month after dose 2 ]
  As measured at the central laboratory
• SARS-CoV-2 S1-binding IgG levels, expressed as GMCs [ Time Frame: 1 month after dose 2 ]
  as measured at the central laboratory
• GMFR in SARS-CoV-2 S1-binding IgG levels [ Time Frame: From before vaccination to 1 month after dose 2 ]
  as measured at the central laboratory

Current Secondary Outcome Measures (submitted: November 23, 2022)

• GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 [ Time Frame: NT50: Baseline (observation prior to Dose 1), 21 days after Dose 1; 7 and 14 days and 6 and 12 months after Dose 2; NT90: Baseline (observation prior to Dose 1), 21 days after Dose 1; 7 and 14 days after Dose 2 ]
  GMTs of SARS-CoV-2 neutralizing titers were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student's t distribution. GMTs of SARS-CoV-2 NT50 and neutralization titer 90% (NT90) were reported in this outcome measure.
• GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2 [ Time Frame: NT50: Before vaccination up to 21 days after Dose 1; 7 and 14 days and 6 and 12 months after Dose 2; NT90: Before vaccination up to 21 days after Dose 1; 7 and 14 days after Dose 2 ]
  GMFR was defined as the result after vaccination divided by the result before vaccination. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t distribution). GMFRs of SARS-CoV-2 NT50 and NT90 were reported in this outcome measure.
• GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 1, 6 and 12 Months After Dose 2 in Participants With or Without Confirmed COVID-19 Before Dose 2 [ Time Frame: Baseline (observation prior to Dose 1), 21 days after Dose 1; 7 and 14 days and 1, 6 and 12 months after Dose 2 ]
  GMTs of SARS-CoV-2 neutralizing titers was planned to be calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student's t distribution.
• GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 1, 6 and 12 Months After Dose 2 in Participants With or Without Confirmed COVID-19 Before Dose 2 [ Time Frame: Before vaccination up to 21 days after Dose 1; 7 and 14 days after Dose 2 and 1, 6 and 12 months after Dose 2 ]
  GMFR was defined as the result after vaccination divided by the result before vaccination. GMFRs and the corresponding 2-sided 95% CIs were planned to be calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t distribution).

Original Secondary Outcome Measures (submitted: October 14, 2020)

• SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: Through 1 year after dose 2 ]
  As measured at the central laboratory
• GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point [ Time Frame: Through 1 year after dose 2 from baseline ]
  As measured at the central laboratory
• SARS-CoV-2 S1-binding IgG levels, expressed as GMCs [ Time Frame: Through 1 year after dose 2 ]
  As measured at the central laboratory
• GMFR in SARS-CoV-2 S1-binding IgG levels from before vaccination to each subsequent time point [ Time Frame: Through 1 year after dose 2 from baseline ]
  As measured at the central laboratory
• GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 S1-binding IgG levels [ Time Frame: Through 1 year after dose 2 ]
  As measured at the central laboratory

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults
• Official Title: A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, AND OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY JAPANESE ADULTS

Brief Summary

This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults.

The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19:

• As 2 doses, separated by 21 days
• At a single dose level
• In adults 20 to 85 years of age

• Detailed Description: From protocol amendment 3, this study is transitioned from a clinical trial to a postmarketing study (Phase 4) according to the Japanese regulation, because BNT162b2 was approved by the Ministry of Health, Labour and Welfare on 14 February 2021.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention

Condition

• SARS-CoV-2 Infection
• COVID-19

Intervention

• Biological: BNT162b2
  BNT162b2 (intramuscular injection)
• Other: Placebo
  Placebo (intramuscular injection)

Study Arms

• Experimental: BNT162b2
  BNT162b2 (intramuscular injection)
  Intervention: Biological: BNT162b2
• Placebo Comparator: Placebo
  Placebo (intramuscular injection)
  Intervention: Other: Placebo

• Publications *: Haranaka M, Baber J, Ogama Y, Yamaji M, Aizawa M, Kogawara O, Scully I, Lagkadinou E, Tureci Ӧ, Sahin U, Dormitzer PR, Gruber WC, Lockhart S. A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults. Nat Commun. 2021 Dec 14;12(1):7105. doi: 10.1038/s41467-021-27316-2.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 14, 2020): 160
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 25, 2021
• Actual Primary Completion Date: November 25, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Japanese male or female participants between the ages of 20 and 85 years, inclusive, at randomization.
• Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
• Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
• Capable of giving personal signed informed consent.

Exclusion Criteria:

• 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.
• Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• Receipt of medications intended to prevent COVID-19.
• Previous confirmed diagnosis of COVID-19.
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Women who are pregnant or breastfeeding.
• Previous vaccination with any coronavirus vaccine.
• Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
• Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
• Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
• Previous participation in other studies involving study intervention containing lipid nanoparticles.
• Subset only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
• Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT04588480
• Other Study ID Numbers: C4591005
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: BioNTech SE
• Original Responsible Party: Same as current
• Current Study Sponsor: BioNTech SE
• Original Study Sponsor: Same as current
• Collaborators: Pfizer

Investigators

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

• PRS Account: BioNTech SE
• Verification Date: January 2023