A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals
NCT ID: NCT05472038
Last Updated: 2025-10-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
1453 participants
INTERVENTIONAL
2022-07-26
2024-03-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
For all cohorts (groups of participants), this study is seeking participants who are healthy (who may have preexisting disease if it is stable); All participants will receive a single dose of the study vaccine at the first study clinic and will return to the study clinic at least 4 more times. At each clinic visit, a blood sample will be taken. The study is about 6 months long for each participant. The vaccine candidates in this study are investigational but are very similar to BNT162b2 (Comirnaty), a COVID-19 RNA vaccine approved for use in the US and in many countries.
For Cohort 1, this study included participants who were:
* 18 through 55 years of age
* have received 1 booster dose of a US-authorized COVID-19 vaccine, with the last dose being 90 or more days before Visit 1 of this study.
All participants in Cohort 1 will receive 1 of the 2 study vaccines at a 30 microgram dose: BNT162b5 Bivalent (WT/OMI BA.2) or BNT162b2 Bivalent (WT/OMI BA.1).
For Cohort 2, this study included participants who were:
* 12 years of age and older
* have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study.
Participants 12 through 17 years of age will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms.
Participants 18 years and older will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at either a 30 microgram or a 60 microgram dose.
For Cohort 3, this study included participants who were:
* 18 years of age and older
* have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study.
* Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms.
For Cohort 4, this study is seeking participants who are:
* 18 through 55 years of age
* have received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized BA.4/BA.5-adapted bivalent vaccine and dose level at least 150 days before Visit 1 of this study.
All participants in Cohort 4 will receive 1 of the 5 study vaccines at a 30 microgram dose: BNT162b2 Bivalent (Original/ OMI BA.4/BA.5), BNT162b5 Bivalent (Original/OMI BA.4/BA.5), BNT162b6 Bivalent (Original/OMI BA.4/BA.5), BNT162b7 Bivalent (Original/OMI BA.4/BA.5) or BNT162b7 Monovalent (OMI BA.4/BA.5).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years
NCT07069309
A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
NCT04816669
Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older
NCT04762680
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
NCT07300839
A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults
NCT05037097
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2)
Participants will receive 30 µg of BNT162b5 Bivalent (WT/OMI BA.2) at Visit 1.
BNT162b5 Bivalent (WT/OMI BA.2)
BNT162b5 Wild Type and BNT162b5 OMICRON \[B.1.1.529 sublineage BA.2\]
Cohort 1: BNT162b2 Bivalent (WT/OMI BA.1)
Participants will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.1) at Visit 1.
BNT162b2 Bivalent (WT/OMI BA.1)
BNT162b2 Wild Type and BNT162b2 OMICRON \[B.1.1.529 sublineage BA.1\]
Cohort 2 -Group 1: 12-17 years; 30 µg
Participants 12-17 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
BNT162b2 Wild Type and BNT162b2 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Cohort 2 - Group 2: 18-55 years; 30 µg
Participants 18-55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
BNT162b2 Wild Type and BNT162b2 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Cohort 2 - Group 3: 18-55 years; 60 µg
Participants 18-55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
BNT162b2 Wild Type and BNT162b2 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Cohort 2 - Group 4: >55 years; 30 µg
Participants over 55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
BNT162b2 Wild Type and BNT162b2 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Cohort 2 - Group 5: >55 years; 60 µg
Participants over 55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
BNT162b2 Wild Type and BNT162b2 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Cohort 3 - Group 1: 18-55 years; 30 µg
Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.
BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
BNT162b2 Wild Type and BNT162b2 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Cohort 3 - Group 2: >55 years; 30 µg
Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1.
BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
BNT162b2 Wild Type and BNT162b2 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Cohort 4: BNT162b2 Bivalent (Original/OMI BA.4/BA.5)
Participants will receive 30 µg of BNT162b2 Bivalent (Original/OMI BA.4/BA.5) at Visit 1
BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
BNT162b2 Wild Type and BNT162b2 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Cohort 4: BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
Participants will receive 30 µg of BNT162b5 Bivalent (Original/OMI BA.4/BA.5) at Visit 1
BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
BNT162b5 Wild Type and BNT162b5 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Cohort 4: BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
Participants will receive 30 µg of BNT162b6 Bivalent (Original/OMI BA.4/BA.5) at Visit 1
BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
BNT162b6 Wild Type and BNT162b6 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Cohort 4: BNT162b7 Bivalent (Original/OMI BA.4/BA.5)
Participants will receive 30 µg of BNT162b7 Bivalent (Original/OMI BA.4/BA.5) at Visit 1
BNT162b7 Bivalent (Original/OMI BA.4/BA.5)
BNT162b7 Wild Type and BNT162b7 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Cohort 4: BNT162b7 Monovalent (OMI BA.4/BA.5)
Participants will receive 30 µg of BNT162b7 Monovalent (OMI BA.4/BA.5) at Visit 1
BNT162b7 Monovalent (OMI BA.4/BA.5)
BNT162b7 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BNT162b5 Bivalent (WT/OMI BA.2)
BNT162b5 Wild Type and BNT162b5 OMICRON \[B.1.1.529 sublineage BA.2\]
BNT162b2 Bivalent (WT/OMI BA.1)
BNT162b2 Wild Type and BNT162b2 OMICRON \[B.1.1.529 sublineage BA.1\]
BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
BNT162b2 Wild Type and BNT162b2 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
BNT162b5 Wild Type and BNT162b5 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
BNT162b6 Wild Type and BNT162b6 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
BNT162b7 Bivalent (Original/OMI BA.4/BA.5)
BNT162b7 Wild Type and BNT162b7 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
BNT162b7 Monovalent (OMI BA.4/BA.5)
BNT162b7 OMICRON \[B.1.1.529 sublineage BA.4/BA.5\]
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Cohort 1: 18 through 55 years of age.
* Cohort 2: 12 years of age and older.
* Cohort 3: 18 years of age and older.
* Cohort 4: 18 through 55 years of age.
2. Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
3. Healthy participants (stable pre-existing disease permitted).
4. Capable of giving signed informed consent.
5. Prior COVID-19 vaccination history:
Cohort 1:
\- Received of 1 booster dose of a US-authorized COVID-19 vaccine, with the dose being 90 or more days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.
Cohorts 2 and 3:
\- Received 3 prior doses of 30 micrograms BNT162b2, with last dose being 150 to 365 days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.
Cohort 4:
\- Received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized Omicron BA.4/BA.5-adapted vaccine and dose level at least 150 days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.
Exclusion Criteria
2. Known or suspected immunodeficiency.
3. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
4. Women who are pregnant or breastfeeding.
5. Other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
6. Immunosuppressants/radiotherapy:
Cohorts 1 and 2: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study.
Cohorts 3 and 4: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study.
7. Blood/plasma products, immunoglobulin, or monoclonal antibodies:
Cohorts 1, 2, 3: Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study.
Cohort 4: Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for treatment/prevention of COVID-19 or those considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study.
8. Other study participation:
Cohorts 1 and 2: Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study.
Cohorts 3 and 4: Participation in other studies involving receipt of a study intervention within 28 days before randomization. Anticipated participation in other studies involving a study intervention from randomization through the end of this study.
9. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
10. Cohort 4 only: History of myocarditis or pericarditis
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
BioNTech SE
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anaheim Clinical Trials, LLC
Anaheim, California, United States
California Research Foundation
San Diego, California, United States
Bayview Research Group, LLC
Valley Village, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Clinical Research Consulting
Milford, Connecticut, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Accellacare - Charlotte
Charlotte, North Carolina, United States
PharmQuest Life Sciences, LLC
Greensboro, North Carolina, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
Senders Pediatrics
Cleveland, Ohio, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States
Kaiser Permanente Northwest Center for Health Research
Portland, Oregon, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, United States
Benchmark Research
Austin, Texas, United States
Tekton Research, LLC.
Austin, Texas, United States
DM Clinical Research - Bellaire
Houston, Texas, United States
IMA Clinical Research San Antonio
San Antonio, Texas, United States
DM Clinical Research - MDC
Tomball, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Virginia Research Center
Midlothian, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gayed J, Bangad V, Xu X, Mensa F, Cutler M, Tureci O, Sahin U, Modjarrad K, Swanson KA, Anderson AS, Gurtman A, Kitchin N; C4591054 Study Group. Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine against XBB.1.5, BA.2.86, and JN.1 Sublineages: A Phase 2/3 Trial. Vaccines (Basel). 2024 Jul 2;12(7):734. doi: 10.3390/vaccines12070734.
Gayed J, Diya O, Lowry FS, Xu X, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Lu C, Cutler M, Belanger T, Cooper D, Koury K, Anderson AS, Tureci O, Sahin U, Swanson KA, Modjarrad K, Gurtman A, Kitchin N; C4591054 Study Group. Safety and Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine in Individuals >/=12 Years Old: A Phase 2/3 Trial. Vaccines (Basel). 2024 Jan 24;12(2):118. doi: 10.3390/vaccines12020118.
Usdan L, Patel S, Rodriguez H, Xu X, Lee DY, Finn D, Wyper H, Lowry FS, Mensa FJ, Lu C, Cooper D, Koury K, Anderson AS, Tureci O, Sahin U, Swanson KA, Gruber WC, Kitchin N; C4591044 Study Group. A Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in >/=12-Year-Olds. Clin Infect Dis. 2024 May 15;78(5):1194-1203. doi: 10.1093/cid/ciad718.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-002008-19
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCT05472038
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4591044
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.