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A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04713553
Recruitment Status : Completed
First Posted : January 19, 2021
Results First Posted : December 22, 2022
Last Update Posted : December 22, 2022
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE

Study Description
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Brief Summary:

This is a Phase 3, randomized, observer-blind study in healthy individuals.

The primary study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2):

  • As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches)
  • As a 20-microgram dose, administered from 1 of the manufacturing lots
  • As a 2-dose (separated by 21 days) schedule
  • In people 12 through 50 years of age

The booster study will evaluate the safety, tolerability, and immunogenicity of 2 SARS-CoV-2 RNA vaccine candidates (BNT162b2 and BNT162b2.B.1.351):

  • Each as a 30-microgram dose
  • Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2
  • In people 18 through 50 years of age

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection COVID-19 Biological: BNT162b2 Biological: BNT162b2.B.1.351 Phase 3

Study Design
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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1574 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE PRODUCTION LOTS AND DOSE LEVELS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY PARTICIPANTS 12 THROUGH 50 YEARS OF AGE AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED COVID-19 VACCINE CANDIDATES AS A BOOSTER DOSE IN HEALTHY PARTICIPANTS 18 THROUGH 50 YEARS OF AGE
Actual Study Start Date : February 15, 2021
Actual Primary Completion Date : July 22, 2021
Actual Study Completion Date : July 22, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
30-microgram dose of US manufactured drug substance (Lot 1)
 Biological: BNT162b2
Intramuscular injection
Experimental: Arm 2
30-microgram dose of US manufactured drug substance (Lot 2)
 Biological: BNT162b2
Intramuscular injection
Experimental: Arm 3
30-microgram dose of US manufactured drug substance (Lot 3)
 Biological: BNT162b2
Intramuscular injection
Experimental: Arm 4
30-microgram dose of EU manufactured drug substance (Lot 4)
 Biological: BNT162b2
Intramuscular injection
Experimental: Arm 5
20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)
 Biological: BNT162b2
Intramuscular injection
Experimental: Booster 1: BNT162b2
30-microgram dose
 Biological: BNT162b2
Intramuscular injection
Experimental: Booster 2: BNT162b2.B.1.351
30-microgram dose
 Biological: BNT162b2.B.1.351
Intramuscular injection


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean Ratios (GMRs) of Full-Length S-Binding Immunoglobulin G (IgG) Concentrations Between Individual US Lots 1, 2, and 3 at 1 Month After Dose 2: Primary Study [ Time Frame: 1 Month after Dose 2 ]
    Geometric mean concentration of full-length S-binding IgG level for individual US lots (US lots 1, 2, and 3) was determined and reported in the descriptive section. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratio of Geometric Mean Concentrations (GMCs) of individual US Lots BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3.

  2. Geometric Mean Ratios (GMRs) of Full-Length S-Binding IgG Concentrations Between EU Lot and Pooled US Lots at 1 Month After Dose 2: Primary Study [ Time Frame: 1 Month after Dose 2 ]
    Geometric mean concentration of full-length S-binding IgG level for EU lot and pooled US lots (BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3 reporting arm) were determined and reported in the descriptive section. Assay results below the LLOQ were set to 0.5*LLOQ. GMRs were reported in the statistical analysis section and was calculated as ratios of GMCs of BNT162b2 30 mcg: EU Lot and pooled US Lots (BNT162b2 30 mcg: US Lot 1, BNT162b2 30 mcg: US Lot 2 and BNT162b2 30 mcg: US Lot 3 reporting arm).

  3. Geometric Mean Ratios (GMRs) of SARS-CoV-2 Neutralizing Titers Between 20-microgram Dose and 30-microgram Dose at 1 Month After Dose 2: Primary Study [ Time Frame: 1 Month after Dose 2 ]
    Geometric mean titer for SARS-CoV-2 neutralizing titers for 20 mcg dose and 30 mcg dose of US Lot 1 was determined and reported in the descriptive section. GMTs and 2-sided 95% CIs were calculated by exponentiating the least square (LS) mean of the titers and corresponding CIs based on linear regression model. Assay results below the LLOQ were set to 0.5*LLOQ. GMRs were reported in the statistical analysis section and were calculated as the ratio of geometric mean titer of the 20-mcg dose (US Lot 1) to the geometric mean titer of the 30 mcg dose (US Lot 1).

  4. Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study [ Time Frame: Within 7 days after Dose 1 ]
    Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 1. Redness, swelling, and pain at injection site after Dose 1 were reported.

  5. Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study [ Time Frame: Within 7 days after Dose 2 ]
    Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 2. Redness, swelling, and pain at injection site after Dose 2 were reported.

  6. Percentage of Participants With Local Reactions Within 7 Days After Any Dose: Primary Study [ Time Frame: Within 7 days after any dose ]
    Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination. Redness, swelling, and pain at injection site after any dose were reported.

  7. Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Booster Study [ Time Frame: Within 7 days after Dose 3 ]
    Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 3. Redness, swelling, and pain at injection site after Dose 3 were reported.

  8. Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study [ Time Frame: Within 7 days after Dose 1 ]
    Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 1 were reported.

  9. Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study [ Time Frame: Within 7 days after Dose 2 ]
    Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 C and categorized as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 2 were reported.

  10. Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study [ Time Frame: Within 7 days after any dose ]
    Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 C and categorized as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after any dose were reported.

  11. Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study [ Time Frame: Within 7 days after Dose 3 ]
    Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 C and categorized as >=38.0 to 38.4 C; >38.4 to 38.9 C; >38.9 to 40.0 C; >40.0 C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, diarrhea, and use of antipyretic/analgesic medication after Dose 3 were reported.

  12. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2: Primary Study [ Time Frame: Day 1 of Dose 1 up to 1 Month after Dose 2 (for a maximum of 2 months) ]
    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.

  13. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 3 to 1 Month After Dose 3: Booster Study [ Time Frame: From Dose 3 to 1 Month after Dose 3 (for a maximum of 35 days) ]
    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.

  14. Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain at Baseline: Booster Study [ Time Frame: Baseline (prior to Dose 1 of Primary study) ]
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

  15. Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 2: Booster Study [ Time Frame: 1 Month after Dose 2 of primary study ]
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

  16. Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain Before Dose 3: Booster Study [ Time Frame: Before Dose 3 ]
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

  17. Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Week After Dose 3: Booster Study [ Time Frame: 1 Week after Dose 3 ]
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

  18. Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 3: Booster Study [ Time Frame: 1 Month after Dose 3 ]
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

  19. Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain at Baseline: Booster Study [ Time Frame: Baseline (prior to Dose 1 of Primary study) ]
    GMTs and 2-sided 95% CIs were planned to be calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).

  20. Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 2: Booster Study [ Time Frame: 1 Month after Dose 2 of primary study ]
    GMTs and 2-sided 95% CIs were planned to be calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).

  21. Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain Before Dose 3: Booster Study [ Time Frame: Before Dose 3 ]
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

  22. Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Week After Dose 3: Booster Study [ Time Frame: 1 Week after Dose 3 ]
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

  23. Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 3: Booster Study [ Time Frame: 1 Month after Dose 3 ]
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.

  24. Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Booster Study [ Time Frame: Baseline (prior to Dose 1 of Primary study) ]
    GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  25. Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 2: Booster Study [ Time Frame: 1 Month after Dose 2 of primary study ]
    GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  26. Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels Before Dose 3: Booster Study [ Time Frame: Before Dose 3 ]
    GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  27. Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Week After Dose 3: Booster Study [ Time Frame: 1 Week after Dose 3 ]
    GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  28. Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 3: Booster Study [ Time Frame: 1 Month after Dose 3 ]
    GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  29. Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study [ Time Frame: From 1 Month after Dose 2 to 1 Week after Dose 3 ]
    GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 week after Dose 3 to the geometric mean concentration of IgG at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  30. Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study [ Time Frame: From 1 Month after Dose 2 to 1 Month after Dose 3 ]
    GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 3 to the geometric mean concentration of IgG at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  31. Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Week After Dose 3: Booster Study [ Time Frame: Before Dose 3 to 1 Week after Dose 3 ]
    GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 week after Dose 3 to the geometric mean concentration of IgG before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  32. Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Month After Dose 3: Booster Study [ Time Frame: Before Dose 3 to 1 Month after Dose 3 ]
    GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 3 to the geometric mean concentration of IgG before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  33. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study [ Time Frame: From 1 Month after Dose 2 to 1 Week after Dose 3 ]
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  34. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study [ Time Frame: From 1 Month after Dose 2 to 1 Month after Dose 3 ]
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after dose 2. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  35. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Week After Dose 3: Booster Study [ Time Frame: Before Dose 3 to 1 Week after Dose 3 ]
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  36. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Month After Dose 3: Booster Study [ Time Frame: Before Dose 3 to 1 Month after Dose 3 ]
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 reference-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 reference-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  37. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain From 1 Month After Dose 2 to 1 Week After Dose 3: Booster Study [ Time Frame: From 1 Month after Dose 2 to 1 Week after Dose 3 ]
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after dose 2. GMFRs were planned to be calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).

  38. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain From 1 Month After Dose 2 to 1 Month After Dose 3: Booster Study [ Time Frame: From 1 Month after Dose 2 to 1 Month after Dose 3 ]
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after dose 2. GMFRs were planned to be calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).

  39. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Week After Dose 3: Booster Study [ Time Frame: Before Dose 3 to 1 Week after Dose 3 ]
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 week after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  40. Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Month After Dose 3: Booster Study [ Time Frame: Before Dose 3 to 1 Month after Dose 3 ]
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 B.1.351-strain at 1 month after Dose 3 to the geometric mean titers of SARS-CoV-2 B.1.351-strain before dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  41. Percentage of Participants With Seroresponse to Reference Strain at 1 Month After Dose 2: Booster Study [ Time Frame: 1 Month after Dose 2 ]
    Seroresponse was defined as greater than equal to (>=) 4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  42. Percentage of Participants With Seroresponse to Reference Strain Before Dose 3: Booster Study [ Time Frame: Before Dose 3 ]
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  43. Percentage of Participants With Seroresponse to Reference Strain 1 Week After Dose 3: Booster Study [ Time Frame: 1 Week after Dose 3 ]
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  44. Percentage of Participants With Seroresponse to Reference Strain 1 Month After Dose 3: Booster Study [ Time Frame: 1 Month after Dose 3 ]
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point. If the baseline measurement was below LLOQ, a post vaccination measurement of >=4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  45. Percentage of Participants With Seroresponse to B.1.351 Variant Strain at 1 Month After Dose 2: Booster Study [ Time Frame: 1 Month after Dose 2 ]
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.

  46. Percentage of Participants With Seroresponse to B.1.351 Variant Strain Before Dose 3: Booster Study [ Time Frame: Before Dose 3 ]
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.

  47. Percentage of Participants With Seroresponse to B.1.351 Variant Strain 1 Week After Dose 3: Booster Study [ Time Frame: 1 Week after Dose 3 ]
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.

  48. Percentage of Participants With Seroresponse to B.1.351 Variant Strain 1 Month After Dose 3: Booster Study [ Time Frame: 1 Month after Dose 3 ]
    Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.


Secondary Outcome Measures :
  1. Geometric Mean Concentrations (GMCs) of Full-Length S-Binding IgG Levels at Baseline and 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study [ Time Frame: Baseline (before Dose 1), 1 Month after Dose 2 ]
    GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5* LLOQ.

  2. Geometric Mean Fold Rises (GMFRs) in Full-Length S-Binding lgG Levels From Baseline to 1 Month After Dose 2 for 30 mcg Dose of BNT162b2: Primary Study [ Time Frame: From Baseline (before Dose 1) up to 1 Month after Dose 2 ]
    GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.

  3. Geometric Mean Titers (GMT) of SARS-CoV-2 Neutralizing Titers at Baseline and 1 Month After Dose 2 for 20 mcg and 30 mcg Dose of BNT162b2 From US Lot 1: Primary Study [ Time Frame: Baseline (before Dose 1), 1 Month after Dose 2 ]
    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5* LLOQ.

  4. Geometric Mean Fold Rises (GMFRs) in SARS-CoV-2 Neutralizing Titers From Baseline to 1 Month After Dose 2 for 20 mcg and 30 mcg Dose of BNT162b2 From US Lot 1: Primary Study [ Time Frame: From Baseline (before Dose 1) up to 1 Month after Dose 2 ]
    GMFRs were defined as ratios of the geometric mean titers of SARS-CoV-2 at 1 month after Dose 2 to the geometric mean titers of SARS-CoV-2 at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5* LLOQ.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary study: Male or female participants between the ages of 12 and 50 years, inclusive, at randomization.
  • Booster study: Male or female participants between the ages of 18 and 50 years, inclusive, at rerandomization.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving 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 HIV, HCV, or HBV.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

  • Previous 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.

    . 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.
  • Primary study: Previous vaccination with any coronavirus vaccine.
  • Booster study: Previous vaccination with any coronavirus vaccine outside of this study.
  • Receipt of medications intended to prevent COVID-19.
  • Individuals who receive treatment with radiotherapy or 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.
  • Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Additional Exclusion Criteria for the Booster study:

  • Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness within 48 hours before study intervention administration.
  • Receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other nonstudy vaccine within 28 days, before or after study intervention administration.
  • Receipt of short-term (<14 days) systemic corticosteroids. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713553


Locations
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United States, California
Kaiser Permanente Oakland
Oakland, California, United States, 94611
United States, Connecticut
Clinical Research Consulting
Milford, Connecticut, United States, 06460
United States, Florida
Indago Research & Health Center, Inc
Hialeah, Florida, United States, 33012
Research Centers of America
Hollywood, Florida, United States, 33024
Clinical Neuroscience Solutions
Orlando, Florida, United States, 32801
United States, Georgia
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Idaho
Solaris Clinical Research
Meridian, Idaho, United States, 83646
United States, Kentucky
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States, 40004
United States, New Jersey
Amici Clinical Research LLC
Raritan, New Jersey, United States, 08869
United States, North Carolina
Accellacare - Wilmington
Wilmington, North Carolina, United States, 28401
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45206
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Texas
Texas Center for Drug Development, Inc.
Houston, Texas, United States, 77081
Clinical Trials of Texas, LLC
San Antonio, Texas, United States, 78229
Martin Diagnostic Clinic
Tomball, Texas, United States, 77375
United States, Utah
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
BioNTech SE
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by BioNTech SE:
Study Protocol  [PDF] May 3, 2021
Statistical Analysis Plan  [PDF] October 15, 2021

More Information
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Additional Information:

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Responsible Party: BioNTech SE
ClinicalTrials.gov Identifier: NCT04713553    
Other Study ID Numbers: C4591017
First Posted: January 19, 2021    Key Record Dates
Results First Posted: December 22, 2022
Last Update Posted: December 22, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
BNT162b2
BNT162B2.1.B.351
Additional relevant MeSH terms:
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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