SARS-CoV-2 InfectionPhase 3NCT04713553

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

A Phase 3 study testing BNT162b2 and BNT162b2.B.1.351 in people with SARS-CoV-2 Infection and COVID-19, run by BioNTech SE at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 12 to 50 yearsHealthy volunteers can take part
Conditions the study is for: SARS-CoV-2 Infection, COVID-19
What is being tested?: BNT162b2 and BNT162b2.B.1.351
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,574 participants
Where: 17 sitesUnited States
Study dates: 15 Feb 2021to 22 Jul 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 50 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Show all 19Show fewer

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.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

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

Other trials in United States

About this study

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

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

Conditions: SARS-CoV-2 Infection, COVID-19
Being tested: BNT162b2, BNT162b2.B.1.351
Keywords: COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine, BNT162b2, BNT162B2.1.B.351
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BNT162b2Biological
Intramuscular injection
BNT162b2.B.1.351Biological
Intramuscular injection

Study groups in NCT04713553
Study group	Role	What they receive
Arm 1	Experimental	30-microgram dose of US manufactured drug substance (Lot 1) Receives: Biological: BNT162b2
Arm 2	Experimental	30-microgram dose of US manufactured drug substance (Lot 2) Receives: Biological: BNT162b2
Arm 3	Experimental	30-microgram dose of US manufactured drug substance (Lot 3) Receives: Biological: BNT162b2
Arm 4	Experimental	30-microgram dose of EU manufactured drug substance (Lot 4) Receives: Biological: BNT162b2
Arm 5	Experimental	20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot) Receives: Biological: BNT162b2
Booster 1: BNT162b2	Experimental	30-microgram dose Receives: Biological: BNT162b2
Booster 2: BNT162b2.B.1.351	Experimental	30-microgram dose Receives: Biological: BNT162b2.B.1.351

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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.
Measured: 1 Month after Dose 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
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).
Measured: 1 Month after Dose 2
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
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).
Measured: 1 Month after Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study
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.
Measured: Within 7 days after Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study
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.
Measured: Within 7 days after Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Any Dose: Primary Study
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.
Measured: Within 7 days after any dose
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Booster Study
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.
Measured: Within 7 days after Dose 3
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study
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.
Measured: Within 7 days after Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study
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.
Measured: Within 7 days after Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Any Dose: Primary Study
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.
Measured: Within 7 days after any dose
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Booster Study
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.
Measured: Within 7 days after Dose 3
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2: Primary Study
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.
Measured: Day 1 of Dose 1 up to 1 Month after Dose 2 (for a maximum of 2 months)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 3 to 1 Month After Dose 3: Booster Study
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.
Measured: From Dose 3 to 1 Month after Dose 3 (for a maximum of 35 days)
Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain at Baseline: Booster 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.
Measured: Baseline (prior to Dose 1 of Primary study)
Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 2: Booster 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.
Measured: 1 Month after Dose 2 of primary study
Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain Before Dose 3: Booster 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.
Measured: Before Dose 3
Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Week After Dose 3: Booster 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.
Measured: 1 Week after Dose 3
Geometric Mean Titers (GMTs) of SARS-CoV-2 Reference-strain 1 Month After Dose 3: Booster 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.
Measured: 1 Month after Dose 3
Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain at Baseline: Booster 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).
Measured: Baseline (prior to Dose 1 of Primary study)
Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 2: Booster 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).
Measured: 1 Month after Dose 2 of primary study
Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain Before Dose 3: Booster 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.
Measured: Before Dose 3
Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Week After Dose 3: Booster 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.
Measured: 1 Week after Dose 3
Geometric Mean Titers (GMTs) of SARS-CoV-2 B.1.351-strain 1 Month After Dose 3: Booster 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.
Measured: 1 Month after Dose 3
Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Booster 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.
Measured: Baseline (prior to Dose 1 of Primary study)
Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 2: Booster 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.
Measured: 1 Month after Dose 2 of primary study
Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels Before Dose 3: Booster 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.
Measured: Before Dose 3
Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Week After Dose 3: Booster 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.
Measured: 1 Week after Dose 3
Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels 1 Month After Dose 3: Booster 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.
Measured: 1 Month after Dose 3
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
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.
Measured: From 1 Month after Dose 2 to 1 Week after Dose 3
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
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.
Measured: From 1 Month after Dose 2 to 1 Month after Dose 3
Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Week After Dose 3: Booster Study
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.
Measured: Before Dose 3 to 1 Week after Dose 3
Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels Before Dose 3 to 1 Month After Dose 3: Booster Study
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.
Measured: Before Dose 3 to 1 Month after Dose 3
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
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.
Measured: From 1 Month after Dose 2 to 1 Week after Dose 3
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
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.
Measured: From 1 Month after Dose 2 to 1 Month after Dose 3
Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Week After Dose 3: Booster Study
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.
Measured: Before Dose 3 to 1 Week after Dose 3
Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 Reference-strain Before Dose 3 to 1 Month After Dose 3: Booster Study
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.
Measured: Before Dose 3 to 1 Month after Dose 3
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
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).
Measured: From 1 Month after Dose 2 to 1 Week after Dose 3
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
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).
Measured: From 1 Month after Dose 2 to 1 Month after Dose 3
Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Week After Dose 3: Booster Study
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.
Measured: Before Dose 3 to 1 Week after Dose 3
Geometric Mean Fold Rise (GMFRs) in SARS-CoV-2 B.1.351-strain Before Dose 3 to 1 Month After Dose 3: Booster Study
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.
Measured: Before Dose 3 to 1 Month after Dose 3
Percentage of Participants With Seroresponse to Reference Strain at 1 Month After Dose 2: Booster Study
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.
Measured: 1 Month after Dose 2
Percentage of Participants With Seroresponse to Reference Strain Before Dose 3: Booster Study
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.
Measured: Before Dose 3
Percentage of Participants With Seroresponse to Reference Strain 1 Week After Dose 3: Booster Study
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.
Measured: 1 Week after Dose 3
Percentage of Participants With Seroresponse to Reference Strain 1 Month After Dose 3: Booster Study
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.
Measured: 1 Month after Dose 3
Percentage of Participants With Seroresponse to B.1.351 Variant Strain at 1 Month After Dose 2: Booster Study
Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.
Measured: 1 Month after Dose 2
Percentage of Participants With Seroresponse to B.1.351 Variant Strain Before Dose 3: Booster Study
Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.
Measured: Before Dose 3
Percentage of Participants With Seroresponse to B.1.351 Variant Strain 1 Week After Dose 3: Booster Study
Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.
Measured: 1 Week after Dose 3
Percentage of Participants With Seroresponse to B.1.351 Variant Strain 1 Month After Dose 3: Booster Study
Seroresponse was defined as >=4-fold increase from baseline (before Dose 1 in primary study) to the specified time point.
Measured: 1 Month after Dose 3

Secondary outcomes (4)

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
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.
Measured: Baseline (before Dose 1), 1 Month after Dose 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
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.
Measured: From Baseline (before Dose 1) up to 1 Month after Dose 2
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
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.
Measured: Baseline (before Dose 1), 1 Month after Dose 2
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
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.
Measured: From Baseline (before Dose 1) up to 1 Month after Dose 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202122 Jul 2021

First posted19 Jan 2021
Study start15 Feb 2021
Primary completion22 Jul 2021
Study completion22 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
More trials run by BioNTech SEThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,574 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04713553
Sponsor's protocol ID: C4591017
Status last verified: Nov 2022
First submitted: 15 Jan 2021
Last updated: 22 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination

All SARS-CoV-2 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04713553
Acronym / sponsor ID: C4591017
Conditions: SARS-CoV-2 Infection, COVID-19
Keywords: COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine, BNT162b2, BNT162B2.1.B.351
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,574 participants (actual)
Lead sponsor: BioNTech SEIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 15 Feb 2021 (actual)
Primary completion: 22 Jul 2021 (actual)
Study completion: 22 Jul 2021 (actual)
First posted: 19 Jan 2021 (actual)
Results: Posted 22 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 7

Arm	Type	Receives
Arm 1	Experimental	Biological: BNT162b230-microgram dose of US manufactured drug substance (Lot 1)
Arm 2	Experimental	Biological: BNT162b230-microgram dose of US manufactured drug substance (Lot 2)
Arm 3	Experimental	Biological: BNT162b230-microgram dose of US manufactured drug substance (Lot 3)
Arm 4	Experimental	Biological: BNT162b230-microgram dose of EU manufactured drug substance (Lot 4)
Arm 5	Experimental	Biological: BNT162b220-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)
Booster 1: BNT162b2	Experimental	Biological: BNT162b230-microgram dose
Booster 2: BNT162b2.B.1.351	Experimental	Biological: BNT162b2.B.1.35130-microgram dose

Who may qualify

Ages: 12 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BNT162b2Intramuscular injection	Biological	Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Booster 1: BNT162b2
BNT162b2.B.1.351Intramuscular injection	Biological	Booster 2: BNT162b2.B.1.351

Primary outcome

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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

4 secondary outcomes

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
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
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
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

Results and safety

Results posted to the registry on 22 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BNT162b2 30 mcg: US Lot 1	351	347
BNT162b2 30 mcg: US Lot 2	352	346
BNT162b2 30 mcg: US Lot 3	347	344
BNT162b2 30 mcg: EU Lot	173	171
BNT162b2 20 mcg: US Lot 1	351	349
BNT162b2 30 mcg: Booster Dose	0	0
BNT162b2.B.1.351 30 mcg: Booster Dose	0	0

Primary outcome: 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 (95% Confidence Interval). Unit: Unit per milliliter

Measure	BNT162b2 30 mcg: US Lot 1 n = 324	BNT162b2 30 mcg: US Lot 2 n = 311	BNT162b2 30 mcg: US Lot 3 n = 310
Value	6299.5 (5835.4)	6231.9 (5763.7)	6774.8 (6264.9)

BNT162b2 30 mcg: US Lot 1 vs BNT162b2 30 mcg: US Lot 2: Geometric mean ratio: 1.01 (95% CI 0.91 to 1.13)
BNT162b2 30 mcg: US Lot 1 vs BNT162b2 30 mcg: US Lot 3: Geometric mean ratio: 0.93 (95% CI 0.83 to 1.04)
BNT162b2 30 mcg: US Lot 2 vs BNT162b2 30 mcg: US Lot 3: Geometric mean ratio: 0.92 (95% CI 0.82 to 1.03)

Population analysed: Evaluable immunogenicity population: Participants who received 2 doses of vaccine in primary study, with Dose 2 received within predefined window, had at least 1 valid immunogenicity result from blood sample collected within an appropriate window at 1 month after Dose 2, were negative for both SARS-CoV-2 test (RT-PCR and N-blinding antibody) during study and had no other protocol deviations determined by clinician. Here, "N"= participants evaluable for this outcome measure.

Primary outcome: 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 (95% Confidence Interval). Unit: Unit per milliliter

Measure	BNT162b2 30 mcg: EU Lot n = 160	Pooled US Lots n = 945
Value	6098.6 (5474.7 to 6793.7)	6428.8 (6149.5 to 6720.7)

BNT162b2 30 mcg: EU Lot vs Pooled US Lots: Geometric mean ratio: 0.95 (95% CI 0.84 to 1.07)

Primary outcome: 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 (95% Confidence Interval). Unit: Titer

Measure	BNT162b2 30 mcg: US Lot 1 n = 318	BNT162b2 20 mcg: US Lot 1 n = 324
Value	906.3 (847.8 to 968.9)	976.6 (914.1 to 1043.4)

BNT162b2 30 mcg: US Lot 1 vs BNT162b2 20 mcg: US Lot 1: Geometric Mean Ratio: 0.93 (95% CI 0.84 to 1.02)

Primary outcome: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study

Time frame: Within 7 days after Dose 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	BNT162b2 30 mcg: US Lot 1 n = 351	BNT162b2 30 mcg: US Lot 2 n = 352	BNT162b2 30 mcg: US Lot 3 n = 345	Pooled US Lots n = 1048	BNT162b2 30 mcg: EU Lot n = 173	BNT162b2 20 mcg: US Lot 1 n = 351
Redness	1.1 (0.3 to 2.9)	2.0 (0.8 to 4.1)	2.9 (1.4 to 5.3)	2.0 (1.2 to 3.0)	2.3 (0.6 to 5.8)	2.0 (0.8 to 4.1)
Swelling	2.0 (0.8 to 4.1)	3.7 (2.0 to 6.2)	3.8 (2.0 to 6.4)	3.1 (2.2 to 4.4)	2.9 (0.9 to 6.6)	3.4 (1.8 to 5.9)
Pain at Injection Site	82.9 (78.6 to 86.7)	79.3 (74.6 to 83.4)	84.6 (80.4 to 88.3)	82.3 (79.8 to 84.5)	86.1 (80.1 to 90.9)	78.1 (73.4 to 82.3)

Population analysed: Safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs and SAEs-For primary study: From Dose 1 to 1 Month after Dose 2 (up to a maximum of 2 months); For booster study: From Dose 3 to 1 Month after Dose 3 (up to a maximum of 35 days); Local reactions/systemic events: Within 7 days after each dose. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BNT162b2 30 mcg: US Lot 1	0 of 351 (0%)	341 of 351 (97.2%)	0 of 351
BNT162b2 30 mcg: US Lot 2	0 of 352 (0%)	336 of 352 (95.5%)	0 of 352
BNT162b2 30 mcg: US Lot 3	1 of 346 (0.3%)	335 of 347 (96.5%)	0 of 346
BNT162b2 30 mcg: EU Lot	1 of 173 (0.6%)	165 of 173 (95.4%)	0 of 173
BNT162b2 20 mcg: US Lot 1	0 of 351 (0%)	342 of 351 (97.4%)	0 of 351
BNT162b2 30 mcg: Booster Dose	0 of 31 (0%)	30 of 31 (96.8%)	0 of 31
BNT162b2.B.1.351 30 mcg: Booster Dose	0 of 31 (0%)	31 of 31 (100%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for SARS-CoV-2 Infection

RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BNT162b2 and BNT162b2.B.1.351 in people with SARS-CoV-2 Infection and COVID-19, run by BioNTech SE at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04713553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.