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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This was an exploratory Phase I, randomized, observer-blind, active-controlled, dose-escalation trial to evaluate four dose levels (DLs) of BNT162b4 given in combination with BNT162b2 Bivalent (original/Omicron BA.4/BA.5) to select a safe and tolerable dose and to evaluate BNT162b4 + BNT162b2 Bivalent (original/Omicron BA.4/BA.5) when given as Dose 1 and Dose 2 (booster) in Cohorts 1 and 2 and BNT162b4 + BNT162b2 Monovalent (OMI XBB.1.5) when given as Dose 2 (booster) in Cohorts 3a, 3b, 4a, and 4b, and 30 microgram (mcg) BNT162b4 when given alone as Dose 1 and Dose 2 in Cohort 5.
The trial used a staggered dosing process schema, i.e., enrollment into the next higher dose level was done sequentially and subject to safety data from the previous dose levels, with sentinel participants in Cohorts 1, 2, 3a, and 4a. Cohort 3b investigating the same dose level as cohort 3a but in participants aged >55 years was opened after safety data for participants aged 18-55 years in Cohort 3a had been reviewed. Enrollment into Cohorts 4a and 4b was opened after safety data for Cohort 3a and 3b had been reviewed. Cohort 5 participants were not randomized and received two doses of BNT162b4 alone after which a safety review was performed after all participants received Dose 2 in this cohort.
BNT162b4 plus BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) was co-administered (as a single injection).
BNT162b4 alone was administered as a single injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Experimental | Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1. |
|
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Experimental | Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
|
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Experimental | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
|
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 mcg | Biological | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local Reactions- Post Dose 1 | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain, erythema/redness, and induration/swelling. | Up to 7 days post-dose1 |
| Number of Participants With Solicited Local Reactions- Post Dose 2 | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain, erythema/redness, and induration/swelling. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B, as these Cohorts did not receive Dose 2 of the study drugs. | Up to 7 days post-dose 2 |
| Number of Participants With Solicited Systemic Events- Post Dose 1 | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever. | Up to 7 days post-dose 1 |
| Number of Participants With Solicited Systemic Events- Post Dose 2 | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever. | Up to 7 days post-dose 2 |
| Number of Participants With Adverse Events (AEs)-Post Dose 1 | An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | GMTs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibody ancestral strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. | At Pre-dose and Day 28 post dose-1 |
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Inclusion Criteria (applicable to all dose groups unless specified otherwise):
Had given informed consent by signing and dating the informed consent form (ICF) before initiation of any trial-specific procedures.
Were willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions, e.g., to follow good practices to reduce their chances of being infected or spreading COVID-19, and other requirements of the trial. This included that they were able to understand and follow trial-related instructions.
Were aged 18 years and older at randomization (Cohorts 1-4) or 18 to 55 years (Cohort 5), had a body mass index over 18.5 kg/m^2 and under 35 kg/m^2 (Cohorts 1-4) and under 30 kg/m^2 (Cohort 5), and weighed at least 50 kg at Visit 0.
Were healthy, in the clinical judgment of the investigator based on participant-reported medical history data, and physical examination, 12-lead ECG, vital signs, and clinical laboratory test outcomes at Visit 0.
Agreed not to enroll in another trial with an IMP starting from Visit 0 and until 168 days (Cohorts 1-4) and 90 days (Cohort 5) after receiving the last IMP dose. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only): If 168 days after the participant's first IMP dose had passed before they consented to Dose 2, they should have agreed to not enroll in another trial from the time of consent to Dose 2 until 168 days after receiving Dose 2 of the IMP.
Agreed not to be vaccinated with:
Had been vaccinated with at least three doses of an RNA-based COVID-19 vaccine authorized in the United States (US) before Visit 0. The last COVID-19 RNA vaccine dose must have been administered at least 90 days before Visit 1.
Had negative human immunodeficiency virus (HIV) -1 and HIV-2 test results at Visit 0.
Had negative Hepatitis B surface antigen test results at Visit 0.
Had negative anti-Hepatitis C virus (HCV) antibodies, or negative HCV polymerase chain reaction test results if the anti-HCV was positive at Visit 0.
Participants of childbearing potential (POCBP) that had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test result at Visit 0 and negative urine pregnancy test results prior to receiving Dose 1, additionally for Cohort 5 only, a negative urine pregnancy test result prior to receiving Dose 2. Participants born female that were postmenopausal or permanently sterilized (verified by medical records) were not considered POCBP. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only): POCBP that had a negative urine pregnancy test results prior to receiving Dose 2.
POCBP who agreed to practice a highly effective form of contraception and required their male sexual partners to use condoms with a spermicidal agent, starting at Visit 0 and continuously until 28 days after receiving the last IMP dose. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only) : If 28 days after the participant's first IMP dose had passed before they consent to continue Dose 2, they should have a negative urine β-HCG pregnancy test result at Visit 7 and agree to practice a highly effective form of contraception and required their male sexual partners to use condoms with a spermicidal agent, starting from the time they consent to Dose 2 and continuously until 28 days after receiving Dose 2 of IMP.
POCBP who agreed not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting at Visit 0 and continuously until 28 days after receiving the last IMP dose. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only): If 28 days after the participant's first IMP dose had passed before they consented to continue Dose 2, they should have agreed not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting from the time they consented to Dose 2 and continuously until 28 days after receiving Dose 2 of IMP.
Men who were sexually active with partners of childbearing potential and who had not had a verified vasectomy (documented in medical records) that agreed to use condoms with a spermicidal agent and to practice a highly effective form of contraception with their sexual partners born female starting at Visit 0 and continuously until 28 days after receiving the last IMP dose. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only): If 28 days after the participant's first IMP dose had passed before they consent to continue Dose 2, they should have agreed to use condoms with a spermicidal agent and to practice a highly effective form of contraception with their sexual partners born female starting from the time they consent to Dose 2 and continuously until 28 days after receiving Dose 2 of IMP.
Men who were willing to refrain from sperm donation, starting at Visit 0 and continuously until 28 days after receiving the last IMP dose. Inclusion criteria pertaining to Dose 2 (Cohorts 1-4 only): If 28 days after the participant's first IMP dose had passed before they consent to continue Dose 2, they should have agreed to refrain from sperm donation, starting from the time they consent to Dose 2 and continuously until 28 days after receiving Dose 2 of IMP.
Inclusion Criteria (Dose 2 groups, Cohorts 1-4 only):
Participants were eligible to receive Dose 2 if all of the following criteria (in addition to inclusion criteria above) apply:
Exclusion Criteria (applicable to all dose groups unless specified otherwise):
Breastfeeding or intending to become pregnant starting with Visit 0 until 28 days after receiving the last dose of trial IMP or intending to father children starting with Visit 0 until 28 days after receiving the last trial IMP dose.
History of any severe adverse reactions to vaccines or to vaccine components and including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a participant who had an anaphylactic adverse reaction to pertussis vaccine as a child).
Current or history of the following medical conditions:
Uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent US National Heart, Lung, and Blood Institute asthma management guidelines.
Diabetes mellitus type 1 or type 2, or new onset of Diabetes mellitus type 1 or 2 from the administration of Dose 1, including cases controlled with diet alone (Not excluded: history of isolated gestational diabetes).
Hypertension:
Any current or history of cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, symptomatic congestive heart failure, cardiomyopathy or clinically significant arrhythmias. Exclusion pertaining to Dose 2 (all cohorts): Participants who had new onset of cardiovascular disease since enrollment, that, in the opinion of the investigator would constitute an increased risk to the individual's participation in Dose 2 would not receive Dose 2.
A diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). Exclusion pertaining to Dose 2 (all cohorts): Participants who had new onset of a bleeding disorder since enrollment, that, in the opinion of the investigator, would constitute an increased risk to the individual's participation in Dose 2 would not receive Dose 2.
Seizure disorders: History of seizure(s) within the past 3 years. Also excluded if participant had used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
Screening 12-lead ECG that was consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of the trial results. Exclusion pertaining to Dose 2 (all cohorts): Only symptomatic participants or whose clinical picture, in the opinion of the investigator, warrant ECG will have a repeat 12-lead ECG prior to Dose 2.
Current or history of major psychiatric illness, including but not limited to bipolar disorder, major depressive disorder, schizophrenia, autism, and attention deficit-hyperactivity disorder that could interfere with participation and follow-up as required by the trial protocol. Exclusion pertaining to Dose 2 (Cohorts 1-4): Participants who had a change or new onset psychiatric illness.
Current or history of the following diseases associated with immune dysregulation:
Received any non-trial IMP within 28 days before Visit 0 or Visit 7 (Cohorts 1-4) and (Cohort 5) within 28 days before Dose 1 and Dose 2 (except seasonal influenza vaccine, which should be given at least 14 days before or after any administration of IMP).
Received or planned treatment throughout the entire trial 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), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. Inhaled/nebulized (except high doses as per exclusion criteria above), intraarticular, intrabursal, or topical (skin or eyes) corticosteroids were permitted.
Blood/plasma products and/or immunoglobulin containing therapy (including monoclonal antibodies) received:
Received allergy treatment with antigen injections within 28 days before Visit 1 or Visit 7 (Cohorts 1-4) and within 28 days before dosing (Cohort 5) or where allergy treatment with antigen injections were scheduled within 14 days after any visit with IMP administration in this trial.
Participants with a history of SARS-CoV-2 infection (symptomatic or asymptomatic) <60 days prior to randomization.
Have received any non-RNA or unauthorized COVID-19 vaccine, aside from Dose 1 of the current trial.
Any existing condition which may affect IMP administration and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc.
Were vulnerable individuals as per International Council for Harmonisation (ICH) E6 definition, i.e., are individuals whose willingness to participate in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
Any screening hematology and/or blood chemistry laboratory value that meets the definition of a Grade >=1 abnormality at Visit 0, or an abnormal C-reactive protein (identified by any method) or troponin I value.
History of alcohol abuse or drug addiction within 1 year before Visit 0, or a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their wellbeing if they participate as participants in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
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| Name | Affiliation | Role |
|---|---|---|
| BioNTech Responsible Person | BioNTech SE | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance for Multispecialty Research, LLC | Tempe | Arizona | 85281 | United States | ||
| Hoag Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37164012 | Derived | Arieta CM, Xie YJ, Rothenberg DA, Diao H, Harjanto D, Meda S, Marquart K, Koenitzer B, Sciuto TE, Lobo A, Zuiani A, Krumm SA, Cadima Couto CI, Hein S, Heinen AP, Ziegenhals T, Liu-Lupo Y, Vogel AB, Srouji JR, Fesser S, Thanki K, Walzer K, Addona TA, Tureci O, Sahin U, Gaynor RB, Poran A. The T-cell-directed vaccine BNT162b4 encoding conserved non-spike antigens protects animals from severe SARS-CoV-2 infection. Cell. 2023 May 25;186(11):2392-2409.e21. doi: 10.1016/j.cell.2023.04.007. Epub 2023 Apr 13. | |
| 37079651 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 micrograms (mcg) along with BNT162b4 5 mcg at Day 1. |
| FG001 | Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 16, 2024 | Nov 20, 2025 |
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Dose 1 was given observer-blind for Cohorts 1 to 4 and open-label for Cohort 5. Dose 2 was given open-label for Cohorts 1 to 5.
Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
|
| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Experimental | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
|
| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Experimental | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
|
| Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Active Comparator | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
|
| Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Active Comparator | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
|
| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Experimental | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
|
| BNT162b4 5 mcg | Biological | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
|
| BNT162b4 10 mcg | Biological | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
|
| BNT162b4 15 mcg | Biological | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
|
| BNT162b4 30 mcg | Biological | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
|
| BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg | Biological | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
|
| Up to 28 days post-dose 1 |
| Number of Participants With Adverse Events (AEs)-Post Dose 2 | An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. | Up to 28 days post-dose 2 |
| Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1 | An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment. | Up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and up to 2 months post-dose 1 for Cohort 5 |
| Number of Participants With Serious Adverse Events (SAEs)-Post Dose 2 | An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment. | Up to 6 to 7 months post-dose 2 for Cohorts 2 to 4; and up to 3 months post-dose 2 for Cohort 5 |
| Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Participants with hematological abnormalities for basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets were analyzed and only clinically significant abnormal data was reported in the outcome measure. | At Day 3 post-Dose 1; at Day 7 post-dose 1 |
| Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Participants with hematological abnormalities for basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets were analyzed and only clinically significant abnormal data was reported in the outcome measure. | At Day 7 post-dose 2 |
| Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Participants with laboratory abnormalities (clinical chemistry) for alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, C-reactive protein, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, high sensitivity C reactive protein, indirect bilirubin, lipase, total bilirubin, troponin I type 3 and urea nitrogen were analyzed and only abnormal clinically significant data was reported in the outcome measure. | At Day 3 post-Dose 1; at Day 7 post-dose 1 |
| Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Participants with laboratory abnormalities (clinical chemistry) for alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, C-reactive protein, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, high sensitivity C reactive protein, indirect bilirubin, lipase, total bilirubin, troponin I type 3 and urea nitrogen were analyzed and only clinically significant abnormal data was reported in the outcome measure. | At Day 7 post-dose 2 |
| Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Participants with only clinically significant new ECG abnormalities were reported in the outcome measure. | At Day 3 post-Dose 1; at Day 7 post-dose 1 |
| Number of Participants With Clinically Significant New ECG Abnormalities -Post Dose 2 | Participants with only clinically significant new ECG abnormalities were reported in the outcome measure. | At Day 7 post-dose 2 |
| Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade >=3 were reported in the outcome measure. | At Day 3 post-dose 1; at Day 7 post-dose 1 |
| Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade >=3 were reported in the outcome measure. | At Day 7 post-dose 2 |
| Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade >=3 were reported in the outcome measure. | At Day 3 post-dose 1; at Day 7 post-dose 1 |
| Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade >=3 were reported in the outcome measure. | At Day 7 post-dose 2 |
| Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | GMTs for SARS-CoV-2 neutralizing antibody ancestral strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. | At Pre-dose 2 and Day 28 post-dose 2 |
| Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | GMTs for SARS-CoV-2 Omicron BA.4/BA.5 strain were measured by valid assay method. | At Pre-dose and Day 28 post-dose 1 |
| Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2 | GMTs for SARS-CoV-2 Omicron BA.4/BA.5 strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. | At Pre-dose 2 and Day 28 post-dose 2 |
| Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | GMTs for SARS-CoV-2 Omicron XBB1.5 strain were measured by valid assay method. | At Pre-dose 2 and Day 28 post-dose 2 |
| Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 1) to the results before vaccination (that is pre-dose 1). | From pre-dose 1 to 28 days post-dose 1 |
| Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 2 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2). Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 5 and Comparator Cohorts A and B. | From pre-dose 2 to 28 days post-dose 2 |
| Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 1) to the results before vaccination (that is pre-dose 1). | From pre-dose 1 to 28 days post-dose 1 |
| Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 2 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2). | From pre-dose 2 to 28 days post-dose 2 |
| Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (Omicron XBB1.5)-Post Dose 2 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2). | From Pre-dose 2 to Day 28 post-dose 2 |
| Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1 | Seroresponse was defined as achieving >=4-fold rise from baseline (that is, pre-dose). | At Day 28 post-dose 1 |
| Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 2 | Seroresponse was defined as achieving >=4-fold rise from baseline (that is, pre-dose). | At Day 28 post-dose 2 |
| Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1 | Seroresponse was defined as achieving >=4-fold rise from baseline (that is, pre-dose). | At Day 28 post-dose 1 |
| Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 2 | Seroresponse was defined as achieving >=4-fold rise from baseline (that is, pre-dose). | At Day 28 post-dose 2 |
| Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | Seroresponse was defined as achieving >=4-fold rise from baseline (that is, pre-dose). | At Day 28 post-dose 2 |
| Newport Beach |
| California |
| 92663 |
| United States |
| California Research Foundation | San Diego | California | 92123 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Clinical Research Consulting, LLC | Milford | Connecticut | 06460 | United States |
| Cenexel RCA (Research Centers of America) | Hollywood | Florida | 33024 | United States |
| Research Institute of South Florida, Inc. | Miami | Florida | 33173 | United States |
| Great Lakes Clinical Trials LLC - Andersonville | Chicago | Illinois | 60640 | United States |
| Johnson County Clin-Trials, Inc. (JCCT) | Lenexa | Kansas | 66219 | United States |
| University of Kentucky Center for Clinical and Translational Science (outpatient clinic) | Lexington | Kentucky | 40536 | United States |
| Alliance for Multispecialty Research, LLC (Kansas) | Kansas City | Missouri | 64114 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37909 | United States |
| Clinical Trials of Texas, LLC / Flourish Research | San Antonio | Texas | 78229 | United States |
| Endeavor Clinical Trials, LLC | San Antonio | Texas | 78229 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Derived |
| Wang CY, Peng WJ, Kuo BS, Ho YH, Wang MS, Yang YT, Chang PY, Shen YH, Hwang KP. Toward a pan-SARS-CoV-2 vaccine targeting conserved epitopes on spike and non-spike proteins for potent, broad and durable immune responses. PLoS Pathog. 2023 Apr 20;19(4):e1010870. doi: 10.1371/journal.ppat.1010870. eCollection 2023 Apr. |
Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| FG002 | Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| FG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged greater than (>) 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| FG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| FG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| FG006 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
| FG007 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| FG008 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| Safety Set- Post Dose 1 | Two participants randomized in Cohort 3b received BNT162b2 Bivalent + 5 mcg BNT162b4 treatment in Cohort 1 and were analyzed in Cohort 1 for the safety analysis. |
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| Safety Set- Post Dose 2 | Cohort 1, Comparator Cohorts A and B did not receive Dose 2 of the study drugs. |
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| Dose 1 (At Day 1) |
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| Dose 2 (At 6 Months for Cohorts 1, 2, 3a, 3b,4a, 4b and Comparator Cohorts;at 2 Months for Cohort 5) |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on randomized population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1. |
| BG001 | Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| BG002 | Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| BG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| BG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| BG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| BG006 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
| BG007 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| BG008 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Solicited Local Reactions- Post Dose 1 | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain, erythema/redness, and induration/swelling. | Analysis was performed on safety set that included all participants who received at least one dose of investigational medicinal product (IMP). Here, overall number of participants analyzed signifies participants with available data for the analysis. | Posted | Count of Participants | Participants | Up to 7 days post-dose1 |
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| Primary | Number of Participants With Solicited Local Reactions- Post Dose 2 | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain, erythema/redness, and induration/swelling. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B, as these Cohorts did not receive Dose 2 of the study drugs. | Analysis was performed on dose 2 safety set, that is, all participants who received two doses of IMP. Here, overall number of participants analyzed signifies participants with available data for the analysis. | Posted | Count of Participants | Participants | Up to 7 days post-dose 2 |
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| Primary | Number of Participants With Solicited Systemic Events- Post Dose 1 | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever. | Analysis was performed on safety set that included all participants who received at least one dose of IMP. Here, overall number of participants analyzed signifies participants with available data for the analysis. | Posted | Count of Participants | Participants | Up to 7 days post-dose 1 |
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| Primary | Number of Participants With Solicited Systemic Events- Post Dose 2 | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever. | Analysis was performed on dose 2 safety set. Here, overall number of participants analyzed signifies participants with available data for the analysis. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs. | Posted | Count of Participants | Participants | Up to 7 days post-dose 2 |
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| Primary | Number of Participants With Adverse Events (AEs)-Post Dose 1 | An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. | Analysis was performed on safety set. | Posted | Count of Participants | Participants | Up to 28 days post-dose 1 |
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| Primary | Number of Participants With Adverse Events (AEs)-Post Dose 2 | An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. | Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs. | Posted | Count of Participants | Participants | Up to 28 days post-dose 2 |
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| Primary | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 1 | An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment. | Analysis was performed on safety set. | Posted | Count of Participants | Participants | Up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and up to 2 months post-dose 1 for Cohort 5 |
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| Primary | Number of Participants With Serious Adverse Events (SAEs)-Post Dose 2 | An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment. | Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs. | Posted | Count of Participants | Participants | Up to 6 to 7 months post-dose 2 for Cohorts 2 to 4; and up to 3 months post-dose 2 for Cohort 5 |
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| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 1 | Participants with hematological abnormalities for basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets were analyzed and only clinically significant abnormal data was reported in the outcome measure. | Analysis was performed on safety set. Here, number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for analysis. | Posted | Count of Participants | Participants | At Day 3 post-Dose 1; at Day 7 post-dose 1 |
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| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters-Post Dose 2 | Participants with hematological abnormalities for basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets were analyzed and only clinically significant abnormal data was reported in the outcome measure. | Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs. | Posted | Count of Participants | Participants | At Day 7 post-dose 2 |
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| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 1 | Participants with laboratory abnormalities (clinical chemistry) for alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, C-reactive protein, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, high sensitivity C reactive protein, indirect bilirubin, lipase, total bilirubin, troponin I type 3 and urea nitrogen were analyzed and only abnormal clinically significant data was reported in the outcome measure. | Analysis was performed on safety set. Here, number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for analysis. | Posted | Count of Participants | Participants | At Day 3 post-Dose 1; at Day 7 post-dose 1 |
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| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry-Post Dose 2 | Participants with laboratory abnormalities (clinical chemistry) for alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, C-reactive protein, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, high sensitivity C reactive protein, indirect bilirubin, lipase, total bilirubin, troponin I type 3 and urea nitrogen were analyzed and only clinically significant abnormal data was reported in the outcome measure. | Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs. | Posted | Count of Participants | Participants | At Day 7 post-dose 2 |
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| Primary | Number of Participants With Clinically Significant New Electrocardiogram (ECG) Abnormalities -Post Dose 1 | Participants with only clinically significant new ECG abnormalities were reported in the outcome measure. | Analysis was performed on safety set. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for analysis. | Posted | Count of Participants | Participants | At Day 3 post-Dose 1; at Day 7 post-dose 1 |
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| Primary | Number of Participants With Clinically Significant New ECG Abnormalities -Post Dose 2 | Participants with only clinically significant new ECG abnormalities were reported in the outcome measure. | Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs. | Posted | Count of Participants | Participants | At Day 7 post-dose 2 |
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| Primary | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post-dose 1 | The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade >=3 were reported in the outcome measure. | Analysis was performed on safety set. Here, number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for analysis. | Posted | Count of Participants | Participants | At Day 3 post-dose 1; at Day 7 post-dose 1 |
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| Primary | Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade 0 to Worst Grade >=3: Post Dose 2 | The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade >=3 were reported in the outcome measure. | Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs. | Posted | Count of Participants | Participants | At Day 7 post-dose 2 |
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| Primary | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post Dose 1 | The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade >=3 were reported in the outcome measure. | Analysis was performed on safety set. Here, number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for analysis. | Posted | Count of Participants | Participants | At Day 3 post-dose 1; at Day 7 post-dose 1 |
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| Primary | Number of Participants With Shift of Laboratory Parameters (Clinical Chemistry) From Baseline Grade 0 to Worst Grade >=3: Post-dose 2 | The intensity of AEs and laboratory parameters was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants with shift change from Baseline Grade 0 to Worst Grade >=3 were reported in the outcome measure. | Analysis was performed on dose 2 safety set. Data for this outcome measure was not collected and analyzed for Cohort 1, and Comparator Cohorts A and B as these Cohorts did not receive Dose 2 of the study drugs. | Posted | Count of Participants | Participants | At Day 7 post-dose 2 |
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| Secondary | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 1 | GMTs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibody ancestral strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. | Analysis was performed on Immunogenicity per protocol set that is all participants who received the planned dose of the IMP on Day 1 and who have at least one valid immunogenicity assessment within an appropriate window and have no major protocol deviations that can confound immunogenicity data. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Pre-dose and Day 28 post dose-1 |
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| Secondary | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Ancestral Strain-Post Dose 2 | GMTs for SARS-CoV-2 neutralizing antibody ancestral strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. | Analysis was performed on Immunogenicity per protocol set. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for the analysis at the specified time-point. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Pre-dose 2 and Day 28 post-dose 2 |
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| Secondary | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 1 | GMTs for SARS-CoV-2 Omicron BA.4/BA.5 strain were measured by valid assay method. | Analysis was performed on immunogenicity per protocol set. Here, number analyzed signifies participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Pre-dose and Day 28 post-dose 1 |
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| Secondary | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron BA.4/BA.5)- Post Dose 2 | GMTs for SARS-CoV-2 Omicron BA.4/BA.5 strain were measured by valid assay method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. | Analysis was performed on immunogenicity per protocol set. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for the analysis at the specified time-point. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Pre-dose 2 and Day 28 post-dose 2 |
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| Secondary | Geometric Mean Titers (GMTs) for SARS-CoV-2 Neutralizing Antibody Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | GMTs for SARS-CoV-2 Omicron XBB1.5 strain were measured by valid assay method. | Analysis was performed on immunogenicity per protocol set. Here, overall number of participants analyzed signifies participants with available data for the analysis and number analyzed signifies participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 2, 5 and Comparator Cohorts A and B. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Pre-dose 2 and Day 28 post-dose 2 |
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| Secondary | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 1 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 1) to the results before vaccination (that is pre-dose 1). | Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 5. | Posted | Geometric Mean | 95% Confidence Interval | ratio | From pre-dose 1 to 28 days post-dose 1 |
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| Secondary | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Ancestral Strain-Post Dose 2 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2). Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 5 and Comparator Cohorts A and B. | Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. | Posted | Geometric Mean | 95% Confidence Interval | ratio | From pre-dose 2 to 28 days post-dose 2 |
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| Secondary | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 1 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 1) to the results before vaccination (that is pre-dose 1). | Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. | Posted | Geometric Mean | 95% Confidence Interval | ratio | From pre-dose 1 to 28 days post-dose 1 |
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| Secondary | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (OMI BA.4/BA.5)-Post Dose 2 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2). | Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 3a and 3b, 4a and 4b, 5 and Comparator Cohorts A and B. | Posted | Geometric Mean | 95% Confidence Interval | ratio | From pre-dose 2 to 28 days post-dose 2 |
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| Secondary | Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 Omicron Strain (Omicron XBB1.5)-Post Dose 2 | GMFRs are defined as ratios of the results after vaccination (that is 28 days post-dose 2) to the results before vaccination (that is pre-dose 2). | Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 2, 5 and Comparator Cohorts A and B. | Posted | Geometric Mean | 95% Confidence Interval | ratio | From Pre-dose 2 to Day 28 post-dose 2 |
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| Secondary | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 1 | Seroresponse was defined as achieving >=4-fold rise from baseline (that is, pre-dose). | Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 28 post-dose 1 |
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| Secondary | Percentage of Participants With Seroresponse to SARS-CoV-2 Ancestral Strain-Post Dose 2 | Seroresponse was defined as achieving >=4-fold rise from baseline (that is, pre-dose). | Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts, 1, 5 and Comparator Cohorts A and B. | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 28 post-dose 2 |
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| Secondary | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 1 | Seroresponse was defined as achieving >=4-fold rise from baseline (that is, pre-dose). | Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohort 5. | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 28 post-dose 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (OMI BA.4/BA.5)- Post Dose 2 | Seroresponse was defined as achieving >=4-fold rise from baseline (that is, pre-dose). | Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 3a and 3b, 4a and 4b, 5 and Comparator Cohorts A and B. | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 28 post-dose 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strains (SARS-CoV-2 Omicron XBB1.5)- Post Dose 2 | Seroresponse was defined as achieving >=4-fold rise from baseline (that is, pre-dose). | Analysis was performed on immunogenicity per protocol set. Here, overall number analyzed signifies participants with available data for the analysis. Data for this outcome measure was not planned to be collected and analyzed for Cohorts 1, 2, 5 and Comparator Cohorts A and B. | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 28 post-dose 2 |
|
AE data was collected from Day 1 up to 28 days post each dose. All SAE data collected throughout the study were reported in AE section and were collected from up to 6 to 7 months post-dose 1 for Cohorts 1 to 4 and Comparator Cohorts; and 6 to 7 months post-dose 2 for Cohorts 2 to 4. For Cohort 5, SAEs: from IMP Dose 1 up to 2 months after Dose 1 and from IMP Dose 2 up to 3 months after Dose 2
Analysis was performed on safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-IMP administration or were a SAE. These reactions are presented in the respective outcome measures. Two participants randomized in Cohort 3b received BNT162b2 Bivalent + BNT162b4 5 mcg treatment in Cohort 1 and were analyzed in Cohort 1 for safety analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years | Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 5 mcg at Day 1. | 0 | 48 | 0 | 48 | 3 | 48 |
| EG001 | Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | Participants aged 18-55 years received an intramuscular injection of BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Bivalent 30 mcg along with BNT162b4 10 mcg again as Dose 2 at 6 to 7 months after Dose 1. | 0 | 44 | 1 | 44 | 1 | 44 |
| EG002 | Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. | 0 | 44 | 1 | 44 | 1 | 44 |
| EG003 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. | 0 | 46 | 1 | 46 | 6 | 46 |
| EG004 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. | 0 | 59 | 1 | 59 | 1 | 59 |
| EG005 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG006 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. | 0 | 43 | 2 | 43 | 4 | 43 |
| EG007 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. | 0 | 45 | 1 | 45 | 10 | 45 |
| EG008 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. | 0 | 29 | 0 | 29 | 1 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | Non-systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Spinal cord herniation | Nervous system disorders | Non-systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Renal cyst | Renal and urinary disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment | Also includes solicited systemic reactions that continued longer than 7 days post-IMP administration. |
|
Principal Investigators respectively trial sites shall not publish or refer to in writing or orally, in whole or in part, any data, information or materials generated from the study and the services, without the prior written consent of the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BioNTech clinical trials patient information | BioNTech SE | 061319084 | +49 | patients@biontech.de |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2025 | Nov 20, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Erythema/Redness |
|
| Induration/Swelling |
|
| OG002 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
|
|
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
| OG007 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG008 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
|
|
| OG002 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
|
|
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
| OG007 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG008 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
|
|
| OG002 |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) |
Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
|
|
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
| OG007 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG008 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
|
|
| OG002 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
|
|
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) |
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
| OG007 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG008 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
|
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| OG002 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
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| OG002 | Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
| OG007 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG008 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
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| OG002 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
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Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
| OG007 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG008 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
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Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2, 6 to 7 months after Dose 1. |
| OG003 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2, 6 to 7 months after Dose 1. |
| OG004 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2, 6 to 7 months after Dose 1. |
| OG005 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
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| OG002 | Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
| OG007 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG008 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
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Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
| OG002 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
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| OG002 | Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
| OG007 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG008 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
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Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
| OG002 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received two intramuscular injections of BNT162b4 30 mcg at Day 1 and 2 months post-Dose 1, respectively. |
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| OG002 | Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG007 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
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| OG002 |
| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) |
Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG007 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
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Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG007 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
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| OG002 | Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG007 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
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| OG002 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
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Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG007 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
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| OG002 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
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Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG007 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
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| OG002 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
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Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG007 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
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| OG002 |
| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) |
Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
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Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1, Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1.
| OG003 | Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | Participants aged >55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 15 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 15 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG004 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG005 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG006 | Comparator A: BNT162b2 Bivalent 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
| OG007 | Comparator B: BNT162b2 Bivalent 30 mcg (Aged >55 Years) | Participants aged >55 years received one intramuscular injection of BNT162b2 30 mcg at Day 1. |
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| OG002 | Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | Participants aged 18-55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
| OG003 | Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | Participants aged > 55 years received a dose of BNT162b2 Bivalent 30 mcg (Omicron BA.4/BA.5) along with BNT162b4 30 mcg at Day 1. Participants who consented to receive a second dose of the study drugs received BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg along with BNT162b4 30 mcg again as Dose 2 at 6 to 7 months after Dose 1. |
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| Title | Measurements |
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