Status:
COMPLETED
A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
Lead Sponsor:
BioNTech SE
Collaborating Sponsors:
Pfizer
Conditions:
SARS-CoV-2 Infection
COVID-19
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people...
Eligibility Criteria
Inclusion
- SSA
- Received at least 3 prior doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being a US-authorized Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before Visit 1 (Day 1).
- 12 years of age and older
- Healthy participants (stable pre-existing disease permitted).
- Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
- Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent.
- Exclusion Criteria
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
- Immunocompromised 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.
- Any 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.
- History of myocarditis or pericarditis.
- Receipt of 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.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study.
- Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study.
- 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.
- SSB
- COVID-19 vaccine-naïve.
- Any positive SARS-CoV-2 test result \>28 days before study intervention administration.
- 12 years of age and older.
- Healthy participants (stable pre-existing disease permitted).
- Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
- Capable of giving or parent(s)/legal guardian capable of giving, signed informed consent.
Exclusion
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
- 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.
- Any 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.
- History of myocarditis or pericarditis.
- Receipt of 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.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study intervention administration or planned receipt throughout the study.
- Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study.
- 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.
- SSC
- Inclusion Criteria:
- Cohort 1: 18 years of age and older
- Cohort 2: 12 years of age and older
- Cohort 3: 18 years of age and older
- Healthy participants (stable pre-existing disease permitted).
- Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
- Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent.
- Exclusion Criteria
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
- Immunocompromised 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.
- Any 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.
- History of myocarditis or pericarditis.
- Receipt of 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.
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study.
- Receipt of a COVID-19 vaccine less than 150 days before study intervention administration Visit 1 (Day 1).
- Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study.
- 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.
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2025
Estimated Enrollment :
1051 Patients enrolled
Trial Details
Trial ID
NCT05997290
Start Date
August 10 2023
End Date
March 13 2025
Last Update
March 28 2025
Active Locations (37)
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1
North Alabama Research Center
Athens, Alabama, United States, 35611
2
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
3
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States, 36608
4
Epic Medical Research - Surprise
Surprise, Arizona, United States, 85378