SARS-CoV-2 InfectionPhase 3NCT04816669

A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults

A Phase 3 study testing BNT162b2 in people with SARS-CoV-2 Infection and COVID-19, run by BioNTech SE at 21 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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: SARS-CoV-2 Infection, COVID-19
What is being tested?: BNT162b2
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 629 participants
Where: 21 sitesUnited States
Study dates: 1 Apr 2021to 2 Dec 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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female participants 18 - 55 years of age, inclusive, at Visit 1, (Day 1).
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. Note: Healthy participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included.
Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.
For Dose 3: Participants who received BOTH doses of the lyophilized formulation of BNT162b2 as part of the initial study.

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(s).
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 14Show fewer

Women who are pregnant or breastfeeding.
Previous vaccination with any coronavirus vaccine.
Receipt of medications intended to prevent COVID-19.
Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
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 (LNPs).
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.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Benchmark Research
Austin, Texas, 78705
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, 40004
Aventiv Research Inc
Columbus, Ohio, 43213
University of Texas Medical Branch
Galveston, Texas, 77555
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256
Solaris Clinical Research
Meridian, Idaho, 83646
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
Clinical Neuroscience Solutions
Orlando, Florida, 32801
Amici Clinical Research LLC
Raritan, New Jersey, 08869
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
Clinical Research Atlanta
Stockbridge, Georgia, 30281
DM Clinical Research (Administrative and Storage Office only)
Tomball, Texas, 77375
Martin Diagnostic Clinic
Tomball, Texas, 77375
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Accellacare (formerly PMG Research of Wilmington, LLC)
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 FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE

This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate). Additionally, the study will describe the safety and immunogenicity of an additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose schedule of lyophilized BNT162b2.

2-dose schedule (separated by 21 days)
At a dose of 30µg (as studied in the Phase 2/3 study C4591001)
In healthy adults 18 through 55 years of age
The duration of the study for each participant will be approximately 2 months (3 visits in total)
The study will be conducted in the United States

Conditions: SARS-CoV-2 Infection, COVID-19
Being tested: BNT162b2
Keywords: COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine
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

Study groups in NCT04816669
Study group	Role	What they receive
Lyophilized SDV	Experimental	Not described Receives: Biological: BNT162b2
Frozen liquid MDV (control for lyo SDV)	Experimental	Control for lyophilized SDV Receives: Biological: BNT162b2
Frozen-liquid with LNP size at the upper end of specification	Experimental	Not described Receives: Biological: BNT162b2
RTU	Experimental	Not described Receives: Biological: BNT162b2
Frozen liquid MDV (given as third dose following a primary series of lyophilized BNT162b2)	Experimental	Additional vaccine dose, using the frozen-liquid formulation, offered to participants who originally received 2 doses of the lyophilized formulation of BNT162b2 Receives: Biological: BNT162b2

What is being measured

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

Geometric Mean Titers (GMTs) of Full-Length S-Binding IgG Concentrations of Lyophilized Formulation SDVs and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2
GMTs of full-length S-binding IgG level for lyophilized formulation in SDVs and frozen-Liquid formulation in MDVs were reported in this outcome measure as geometric mean concentration (GMCs) in descriptive data section. GMC and 95 percent (%) confidence interval (CI) 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 ratio (GMR) was calculated as ratios of GMCs of BNT162b2 30 mcg lyophilized SDV and frozen-liquid MDV. GMR are reported in the statistical analysis section.
Measured: 1 Month after Dose 2
Percentage of Participants With Local Reactions 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 each vaccination.
Measured: Within 7 days after Dose 1
Percentage of Participants With Local Reactions 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 each vaccination.
Measured: Within 7 days after Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 1 were reported.
Measured: Within 7 days after Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 2 were reported.
Measured: Within 7 days after Dose 2
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2
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/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Measured: Dose 1 up to 1 Month after Dose 2 (for approximately 2 months)

Secondary outcomes (2)

Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1
GMCs of full-length S-binding IgG levels 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 on Day 1)
Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1
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 on Day 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.

1 Apr 20212 Dec 2021

First posted25 Mar 2021
Study start1 Apr 2021
Primary completion1 Dec 2021
Study completion2 Dec 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: 629 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04816669
Sponsor's protocol ID: C4591020
Status last verified: Nov 2022
First submitted: 24 Mar 2021
Last updated: 23 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

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All SARS-CoV-2 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 23 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 FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE
ClinicalTrials.gov ID: NCT04816669
Acronym / sponsor ID: C4591020
Conditions: SARS-CoV-2 Infection, COVID-19
Keywords: COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 629 participants (actual)
Lead sponsor: BioNTech SEIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 1 Apr 2021 (actual)
Primary completion: 1 Dec 2021 (actual)
Study completion: 2 Dec 2021 (actual)
First posted: 25 Mar 2021 (actual)
Results: Posted 23 Dec 2022

Clinical summary

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

2-dose schedule (separated by 21 days)
At a dose of 30µg (as studied in the Phase 2/3 study C4591001)
In healthy adults 18 through 55 years of age
The duration of the study for each participant will be approximately 2 months (3 visits in total)
The study will be conducted in the United States

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Lyophilized SDV	Experimental	Biological: BNT162b2
Frozen liquid MDV (control for lyo SDV)	Experimental	Biological: BNT162b2Control for lyophilized SDV
Frozen-liquid with LNP size at the upper end of specification	Experimental	Biological: BNT162b2
RTU	Experimental	Biological: BNT162b2
Frozen liquid MDV (given as third dose following a primary series of lyophilized BNT162b2)	Experimental	Biological: BNT162b2Additional vaccine dose, using the frozen-liquid formulation, offered to participants who originally received 2 doses of the lyophilized formulation of BNT162b2

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male or female participants 18 - 55 years of age, inclusive, at Visit 1, (Day 1).
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. Note: Healthy participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included.
Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.
For Dose 3: Participants who received BOTH doses of the lyophilized formulation of BNT162b2 as part of the initial study.

Key exclusion criteria (14 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(s).
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	Frozen liquid MDV (control for lyo SDV), Frozen liquid MDV (given as third dose following a primary series of lyophilized BNT162b2), Frozen-liquid with LNP size at the upper end of specification, Lyophilized SDV, RTU

Primary outcome

Geometric Mean Titers (GMTs) of Full-Length S-Binding IgG Concentrations of Lyophilized Formulation SDVs and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2
Time frame: 1 Month after Dose 2
GMTs of full-length S-binding IgG level for lyophilized formulation in SDVs and frozen-Liquid formulation in MDVs were reported in this outcome measure as geometric mean concentration (GMCs) in descriptive data section. GMC and 95 percent (%) confidence interval (CI) 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 ratio (GMR) was calculated as ratios of GMCs of BNT162b2 30 mcg lyophilized SDV and frozen-liquid MDV. GMR are reported in the statistical analysis section.
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
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 each vaccination.
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
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 each vaccination.
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
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). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 1 were reported.
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Time frame: Within 7 days after Dose 2
Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 2 were reported.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2
Time frame: Dose 1 up to 1 Month after Dose 2 (for approximately 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/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

2 secondary outcomes

Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1
Time frame: Baseline (Before Dose 1 on Day 1)
Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1
Time frame: From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2

Results and safety

Results posted to the registry on 23 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 Lyophilized Single Dose Vial (SDV): Part 1	279	275
BNT162b2 Frozen-Liquid Multi Dose Vial (MDV): Part 1	280	274
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2	0	0
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2	0	0

Primary outcome: Geometric Mean Titers (GMTs) of Full-Length S-Binding IgG Concentrations of Lyophilized Formulation SDVs and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2

Time frame: 1 Month after Dose 2. Geometric mean (95% Confidence Interval). Unit: Unit per milliliter

Measure	BNT162b2 Lyophilized SDV: Part 1 n = 238	BNT162b2 Frozen-Liquid MDV: Part 1 n = 226
Value	4796.8 (4414.1 to 5212.8)	7031.6 (6393.6 to 7733.3)

BNT162b2 Lyophilized SDV: Part 1 vs BNT162b2 Frozen-Liquid MDV: Part 1: Geometric mean ratio: 0.68 (95% CI 0.60 to 0.77)

Population analysed: Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician.

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

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

Measure	BNT162b2 Lyophilized SDV: Part 1 n = 278	BNT162b2 Frozen-Liquid MDV: Part 1 n = 280	BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 n = 35	BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 n = 35
Redness	4.0 (2.0 to 7.0)	5.0 (2.8 to 8.2)	0 (0.0 to 10.0)	2.9 (0.1 to 14.9)
Swelling	3.6 (1.7 to 6.5)	3.6 (1.7 to 6.5)	0 (0.0 to 10.0)	5.7 (0.7 to 19.2)
Pain at Injection Site	78.1 (72.7 to 82.8)	87.1 (82.6 to 90.8)	85.7 (69.7 to 95.2)	68.6 (50.7 to 83.1)

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

Primary outcome: Percentage of Participants With Local Reactions Within 7 Days After Dose 2

Time frame: Within 7 days after Dose 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	BNT162b2 Lyophilized SDV: Part 1 n = 274	BNT162b2 Frozen-Liquid MDV: Part 1 n = 274	BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 n = 35	BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 n = 35
Redness	3.6 (1.8 to 6.6)	5.5 (3.1 to 8.9)	0 (0.0 to 10.0)	0 (0.0 to 10.0)
Swelling	2.9 (1.3 to 5.7)	3.3 (1.5 to 6.1)	0 (0.0 to 10.0)	8.6 (1.8 to 23.1)
Pain at Injection Site	71.2 (65.4 to 76.5)	80.3 (75.1 to 84.8)	71.4 (53.7 to 85.4)	62.9 (44.9 to 78.5)

Primary outcome: Percentage of Participants With Systemic Events Within 7 Days After Dose 1

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

Measure	BNT162b2 Lyophilized SDV: Part 1 n = 278	BNT162b2 Frozen-Liquid MDV: Part 1 n = 280	BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 n = 35	BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 n = 35
Fever >=38.0 degree C	0 (0.0 to 1.3)	3.2 (1.5 to 6.0)	0 (0.0 to 10.0)	0 (0.0 to 10.0)
Fatigue	46.4 (40.4 to 52.5)	57.5 (51.5 to 63.4)	54.3 (36.6 to 71.2)	45.7 (28.8 to 63.4)
Headache	31.3 (25.9 to 37.1)	44.3 (38.4 to 50.3)	37.1 (21.5 to 55.1)	31.4 (16.9 to 49.3)
Chills	8.6 (5.6 to 12.6)	18.6 (14.2 to 23.6)	8.6 (1.8 to 23.1)	8.6 (1.8 to 23.1)
Vomiting	2.9 (1.3 to 5.6)	2.1 (0.8 to 4.6)	5.7 (0.7 to 19.2)	2.9 (0.1 to 14.9)
Diarrhea	14.4 (10.5 to 19.1)	13.9 (10.1 to 18.5)	5.7 (0.7 to 19.2)	11.4 (3.2 to 26.7)
New or worsened muscle pain	16.5 (12.4 to 21.4)	27.1 (22.0 to 32.8)	11.4 (3.2 to 26.7)	20.0 (8.4 to 36.9)
New or worsened joint pain	7.9 (5.0 to 11.7)	15.4 (11.3 to 20.1)	11.4 (3.2 to 26.7)	17.1 (6.6 to 33.6)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BNT162b2 Lyophilized SDV: Part 1	0 of 279 (0%)	262 of 279 (93.9%)	0 of 279
BNT162b2 Frozen-Liquid MDV: Part 1	0 of 280 (0%)	274 of 280 (97.9%)	0 of 280
BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2	0 of 35 (0%)	33 of 35 (94.3%)	0 of 35
BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2	0 of 35 (0%)	31 of 35 (88.6%)	0 of 35
BNT162b2 Frozen-Liquid MDV: Dose 3	0 of 114 (0%)	87 of 114 (76.3%)	0 of 114

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 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

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Respiratory Viral Infections, Influenza

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

21 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 in people with SARS-CoV-2 Infection and COVID-19, run by BioNTech SE at 21 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 14 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 23 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 21 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 23 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 Titers (GMTs) of Full-Length S-Binding IgG Concentrations of Lyophilized Formulation SDVs and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2 (time frame: 1 Month after Dose 2). The study lists 6 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 NCT04816669.

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 23 Dec 2022; AzTrials last refreshed its copy on 31 Oct 2026.