A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 Against COVID-19 in Healthy Participants
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04713553 |
Recruitment Status :
Recruiting
First Posted : January 19, 2021
Last Update Posted : March 24, 2021
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This is a Phase 3, randomized, observer-blind study in healthy individuals.
The 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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
SARS-CoV-2 Infection COVID-19 | Biological: BNT162b2 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1530 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE PRODUCTION LOTS AND DOSE LEVELS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY PARTICIPANTS 12 THROUGH 50 YEARS OF AGE |
Actual Study Start Date : | February 15, 2021 |
Estimated Primary Completion Date : | May 11, 2021 |
Estimated Study Completion Date : | May 11, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm 1
30-microgram dose of US manufactured drug substance (Lot 1)
|
Biological: BNT162b2
Intramuscular injection |
Experimental: Arm 2
30-microgram dose of US manufactured drug substance (Lot 2)
|
Biological: BNT162b2
Intramuscular injection |
Experimental: Arm 3
30-microgram dose of US manufactured drug substance (Lot 3)
|
Biological: BNT162b2
Intramuscular injection |
Experimental: Arm 4
30-microgram dose of EU manufactured drug substance (Lot 4)
|
Biological: BNT162b2
Intramuscular injection |
Experimental: Arm 5
20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)
|
Biological: BNT162b2
Intramuscular injection |
- Geometric Mean Ratio (GMR) of SARS-CoV-2 full-length S-binding or S1-binding antibody levels between US lots (Arms 1, 2 and 3) in participants without evidence of infection during the study [ Time Frame: At 1 month after Dose 2 ]As measured at the central laboratory
- GMR of SARS-CoV-2 full-length S-binding or S1-binding antibody levels between the EU lot (Arm 4) and pooled US lots (Arms 1, 2, and 3) in participants without evidence of infection during the study [ Time Frame: At 1 month after Dose 2 ]As measured at the central laboratory
- GMR of SARS-CoV-2 neutralizing antibody levels between the 20-microgram dose group (Arm 5) and the corresponding 30-microgram dose group (Arm 1, 2, or 3) in participants without evidence of SARS-C0V-2 infection during the study. [ Time Frame: At 1 month after Dose 2 ]As measured at the central laboratory
- Percentage of participants reporting local reactions [ Time Frame: For 7 days after Dose 1 and Dose 2 ]Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
- Percentage of participants reporting systemic events [ Time Frame: For 7 days after Dose 1 and Dose 2 ]Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries.
- Percentage of participants reporting adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2 ]As elicited by investigational site staff
- Percentage of participants reporting serious adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2 ]As elicited by investigational site staff
- Geometric Mean Concentrations (GMCs) of SARS-CoV-2 full-length S-binding or S1-binding antibody levels in participants vaccinated with one of the 30-microgram lots (US or EU). [ Time Frame: At baseline (before Dose 1) and at 1 month after Dose 2 ]As measured at the central laboratory
- Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 full-length S-binding or S1-binding antibody levels in participants vaccinated with one of the 30-microgram lots (US or EU) [ Time Frame: From baseline (before Dose 1) to 1 month after Dose 2 ]As measured at the central laboratory
- GMCs of SARS CoV-2 neutralizing antibody levels in participants vaccinated with the 20-microgram or 30-microgram dose (from same US lot) [ Time Frame: At baseline (before Dose 1) and 1 month after Dose 2 ]As measured at the central laboratory
- GMFRs of SARS-CoV-2 neutralizing antibody levels in participants vaccinated with the 20-microgram or 30-microgram dose (from same US lot). [ Time Frame: From baseline (before Dose 1) to 1 month after Dose 2 ]As measured at the central laboratory

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female participants between the ages of 12 and 50 years, inclusive, at randomization.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent.
Exclusion Criteria:
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Known infection with HIV, HCV, or HBV.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
-
Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Women who are pregnant or breastfeeding.
- 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, 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713553
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
United States, California | |
Kaiser Permanente Oakland | Recruiting |
Oakland, California, United States, 94611 | |
United States, Connecticut | |
Clinical Research Consulting | Recruiting |
Milford, Connecticut, United States, 06460 | |
United States, Florida | |
Indago Research & Health Center, Inc. | Recruiting |
Hialeah, Florida, United States, 33012 | |
Research Centers of America | Recruiting |
Hollywood, Florida, United States, 33024 | |
Clinical Neuroscience Solutions | Recruiting |
Orlando, Florida, United States, 32801 | |
United States, Georgia | |
Clinical Research Atlanta | Recruiting |
Stockbridge, Georgia, United States, 30281 | |
United States, Hawaii | |
East-West Medical Research Institute | Recruiting |
Honolulu, Hawaii, United States, 96814 | |
United States, Idaho | |
Solaris Clinical Research | Recruiting |
Meridian, Idaho, United States, 83646 | |
United States, Kentucky | |
Kentucky Pediatric/Adult Research | Recruiting |
Bardstown, Kentucky, United States, 40004 | |
United States, New Jersey | |
Amici Clinical Research LLC | Recruiting |
Raritan, New Jersey, United States, 08869 | |
United States, North Carolina | |
PMG Research of Wilmington, LLC | Recruiting |
Wilmington, North Carolina, United States, 28401 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45206 | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229-3039 | |
United States, Texas | |
Texas Center for Drug Development, Inc. | Recruiting |
Houston, Texas, United States, 77081 | |
Clinical Trials of Texas, Inc. | Recruiting |
San Antonio, Texas, United States, 78229 | |
Martin Diagnostic Clinic | Recruiting |
Tomball, Texas, United States, 77375 | |
United States, Utah | |
J. Lewis Research, Inc. / Foothill Family Clinic South | Recruiting |
Salt Lake City, Utah, United States, 84121 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | BioNTech SE |
ClinicalTrials.gov Identifier: | NCT04713553 |
Other Study ID Numbers: |
C4591017 |
First Posted: | January 19, 2021 Key Record Dates |
Last Update Posted: | March 24, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Coronavirus Vaccine SARS-CoV-2 RNA Vaccine |