Infections, Respiratory, Infection Viral, Protection Against COVID-19 and Infections With SARS CoV 2, RNA Virus Infections, Vaccine Adverse Reaction, Virus Diseases
Conditions
Keywords
SARS-CoV-2, Severe Acute Respiratory Syndrome (SARS), Coronavirus Disease 2019, COVID-2019, Virus Diseases
Brief summary
Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was cancelled due to changes in the overall clinical development plan. The objectives originally described for Part B have been implemented in the ongoing development via a pivotal Phase I/II/III trial BNT162-02/C4591001 (ClinicalTrials.gov NCT: 04368728). The conducted Part A was a dose-finding part to investigate the optimal dose of four different vaccines (BNT162a1, BNT162b1, BNT162b2, and BNT162c2), allowing dose adjustments upwards and downwards in younger participants. Doses tested in older participants and expansion cohorts were chosen based on acceptability of dosing in younger participants. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 were administered using a Prime/Boost (P/B) regimen with two doses given \ 21 days apart. The vaccine BNT162c2 was also administered using a Single dose (SD) regimen. Four additional expansion cohorts (cohorts 11, 12, 13, and 14) aged from 18 to 85 years received BNT162b2 using a P/B regimen only. In cohort 11, participants received BNT162b2 using one 3 μg prime dose (Dose 1) and one 30 μg boost dose (Dose 2) of BNT162b2. Participants in cohorts 12, 13, and 14 received two doses of BNT162b2 30 µg, each.
Detailed description
This study was a multi-site, Phase I/II, open-label, dose-escalation study. The study included the first-in-human (FIH) dose and dose ranging groups for all four vaccines in healthy younger participants (aged 18 to 55 years \[years\]) and older participants (aged 56 to 85 years). The conducted Part A followed a dose escalation design. Discretionary dose de-escalation and refinement was also planned. Study participants with the FIH immunization and any subsequent dose escalation cohorts were immunized using a sentinel dosing/subject staggering. For any dose de-escalation or dose-refinement cohorts in younger adults, i.e., cohorts with doses lower than previously tested, participants were dosed using a subject staggering process. Cohorts in older participants were optional and dependent on acceptability of dosing in younger participants. Part A consisted of a treatment phase and a follow-up phase. For the BNT162a1 3 µg arm, the Safety Review Committee (SRC) decided to stop dosing after 6 treated participants and to not administer the boost immunization (Dose 2). For the BNT162b1 60 µg arm, the SRC decided to not administer the boost immunization (Dose 2) for the 12 participants.
Interventions
BIOLOGICALBNT162a1
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BIOLOGICALBNT162b1
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BIOLOGICALBNT162b2
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BIOLOGICALBNT162c2
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
Sponsors
BioNTech SE
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures. * They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to practice social distancing and to follow good practices to reduce their chances of being infected or spreading COVID-19), and other requirements of the trial. * They must be able to understand and follow trial-related instructions. * For younger adult cohorts, volunteers must be aged 18 to 55 years, have a body mass index (BMI) over 19 kg/m\^2 and under 30 kg/m\^2, and weigh at least 50 kg at Visit 0. OR For older adult cohorts, volunteers must be aged 56 to 85 years, have a BMI over 19 kg/m\^2 and under 30 kg/m\^2, and weigh at least 50 kg at Visit 0. OR For the immunocompromised adult cohort (Cohort 13), volunteers must be aged 18 to 85 years, have a BMI over 19 kg/m\^2 and under 30 kg/m\^2, and weigh at least 50 kg at Visit 0. * They must be healthy, in the clinical judgment of the investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs (systolic/diastolic blood pressure, pulse rate, body temperature, respiratory rate), and clinical laboratory tests (blood chemistry, hematology, and urine chemistry) at Visit 0. Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. OR For the immunocompromised cohort (Cohort 13); volunteers who have previously received solid organ transplant, or peripheral blood stem cell transplantation ≥6 months after transplantation, or individuals with human immunodeficiency virus (HIV) infection with a CD4+ T-cell count of ≥200 x 10\^6 /L at Visit 0. Individuals with lower T-cell counts will be excluded from the trial on the basis that this represents a significant medical complication. In the clinical judgment of the investigator, volunteers must be immunocompromised but otherwise healthy. After consultation with the Medical Monitor, this may include individuals receiving immunosuppressant therapy due to another confounding disease at least 2 weeks prior to enrollment and/or at least 6 weeks following immunization with BNT162b2, and/or individuals with immunosuppressive treatment of an autoimmune disease if the disease is stable. * Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin urine test at Visit 0 and Visit 1. Women that are postmenopausal or permanently sterilized will be considered as not having reproductive potential. * WOCBP must agree to practice a highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization. WOCBP must agree to require their male partners to use condoms during sexual contact (unless male partners are sterilized or infertile). * WOCBP must confirm that they practice at least one highly effective form of contraception for the 14 days prior to Visit 0. * WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization. * Men who are sexually active with a WOCBP and have not had a vasectomy must agree to practice a highly effective form of contraception with their female partner of childbearing potential during the trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization. * Men must be willing to refrain from sperm donation, starting after Visit 0 and continuously until 60 days after receiving the last immunization. * They must have confirmation of their health insurance coverage prior to Visit 0. * They must agree to not be vaccinated during the trial, starting after Visit 0 and continuously until 28 days after receiving the last immunization.
Exclusion criteria
* Have had any acute illness, as determined by the investigator, with or without fever, within 72 hours prior to the first immunization. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the investigator, the residual symptoms will not compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. * Are breastfeeding on the day of Visit 0 or who plan to breastfeed during the trial, starting after Visit 0 and continuously until at least 90 days after receiving the last immunization. * Have a known allergy, hypersensitivity, or intolerance to the planned investigational medicinal product (IMP) including any excipients of the IMP. * Had any medical condition or any major surgery (e.g., requiring general anesthesia) within the past 5 years which, in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. * Have any surgery planned during the trial, starting after Visit 0 and continuously until at least 90 days after receiving the last immunization. * Had any chronic use (more than 21 continuous days) of any systemic medications, including immunosuppressant's or other immune-modifying drugs (except for Cohort 13), within the 6 months prior to Visit 0 unless in the opinion of the investigator, the medication would not prevent, limit, or confound the protocol-specified assessments or could compromise subject safety. Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. * Had any vaccination within the 28 days prior to Visit 0. * Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Visit 0. * Had administration of another investigational medicinal product including vaccines within 60 days or 5 half-lives (whichever is longer), prior to Visit 0. * Have a known history of active or ongoing hepatitis B or hepatitis C infection; or except for Cohort 13: HIV-1 or HIV-2 infection within the 30 days prior to Visit 0. * Have a positive polymerase chain reaction (PCR)-based test for SARS-CoV-2 within the 30 days prior to Visit 1. * Have a positive drugs of abuse (for amphetamines, benzodiazepines, barbiturates, cocaine, cannabinoids, opiates, methadone, methamphetamines, phencyclidine, and tricyclic antidepressants) result at Visit 0 or Visit 1. * Have a positive breath alcohol test at Visit 0 or Visit 1. * Previously participated in an investigational trial involving lipid nanoparticles. * Are subject to exclusion periods from other investigational trials or simultaneous participation in another clinical trial. When entering the follow-up phase, i.e., after completing the end of treatment (EoT) visit, subjects are allowed to participate in other clinical trials not investigating COVID-19 vaccines or treatments; subjects immunized with BNT162 vaccines in this clinical trial are allowed to participate in other clinical trials involving immunization with BNT162b2. * Have any affiliation with the trial site (e.g., are close relative of the investigator or dependent person, such as an employee or student of the trial site). * Have 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 well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. * Have a history of hypersensitivity or serious reactions to previous vaccinations. * Have a history of Guillain-Barré Syndrome within 6 weeks following a previous vaccination. * Have a history of narcolepsy. * Have history of alcohol abuse or drug addiction within 1 year before Visit 0. * (Except for Cohort 13) Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Visit 0. * Have any abnormality or permanent body art (e.g., tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site. * Have had any blood loss \>450 mL, e.g., due to donation of blood or blood products or injury, within the 7 days prior to Visit 0 or plan to donate blood during the trial, starting after Visit 0 and continuously until at least 7 days after receiving the last immunization. * Have symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. * Have had contact with persons diagnosed with COVID-19 or who tested positive for SARS-CoV-2 by any diagnostic test within the 30 days prior to Visit 1. * Are soldiers, volunteers in detention, contract research organization (CRO) or sponsor staff or their family members. * Regular receipt of inhaled/nebulized corticosteroids (except for Cohort 13). * For older volunteers and for Cohort 13 only: Have a condition known to put them at high risk for severe COVID-19, including those with any of the following risk factors: * Uncontrolled hypertension. * Diabetes mellitus (HbA1c \>8.5% ≥3 months, according to the medical history reported by the subject). * Chronic obstructive pulmonary disease. * Asthma. * Chronic liver disease. * Known Stage 3 or worse chronic kidney disease (glomerular filtration rate \<60 mL/min/1.73 m\^2); Except for post-renal transplant patients who should have (estimated) GFR ≥40 mL/min/1.73 m\^2. * Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies. * Sickle cell disease. * Cancer (except for Cohort 13). * Are immune compromised due to stem cell or organ-transplantation with significant medical complications such as acute or chronic graft rejection or graft versus host disease requiring intensive immunosuppressive treatment, transplant failure or infectious complications or other conditions that would be considered a contraindication for vaccination. * Are immune compromised due to HIV infection with a CD4+ count of \< 200 x 10\^6 /L at screening or significant medical complications such as opportunistic infections, malignant complications (e.g., lymphoma, Kaposi sarcoma), other organ manifestations consistent with advanced AIDS or other conditions that would be considered a contraindication for vaccination. * Resident in a long term facility. * Current vaping or smoking (occasional smoking is acceptable). * History of chronic smoking within the prior year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization) | Solicited local reactions at the injection site (pain, tenderness, erythema/redness, and induration/swelling) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries. |
| Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization) | Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries. |
| The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | 28 days following Dose 1 or up to Dose 2 (whichever was first) | TEAEs without AEs based on solicited reporting via diaries, were analyzed by vaccine, age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade \>=3 TEAE) using the Safety Set. |
| The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | 28 days following Dose 2 or Dose 1 (if no Dose 2 was given) | TEAEs, without AEs based on solicited reporting via diaries, were analyzed by vaccine, age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade \>=3 TEAE) using the Safety Set. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | up to 183 days following Dose 1 | At 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization). |
| Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | up to 183 days following Dose 1 | At 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization). |
| Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | up to 183 days following Dose 1 | At Day 1 (Baseline = Pre-Prime Immunization) and at 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization). |
| Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | up to 1 year following Dose 1 | At 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization). |
| Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | up to 1 year following Dose 1 | At 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization). |
| Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | up to 1 year following Dose 1 | At Day 1 (Baseline = Pre-Prime Immunization) and at 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization). |
| Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | up to 183 days following Dose 1 | At 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization). |
| Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | up to 183 days following Dose 1 | At 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization). |
| Functional Antibody Responses (Titers) for BNT162c2 (SD) | up to 183 days following Dose 1 | At Day 1 (Baseline = Pre Immunization) and at 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization). |
Countries
Germany
Participant flow
Recruitment details
Study participants were selected from the volunteer panel at the clinical CRO, volunteers who responded to either generic or study-specific advertisements in social media, or volunteers who contacted the clinical CRO via a web-based study participant recruitment portal. Study participants were selected from this pool of volunteers according to inclusion and exclusion criteria. The first participant was enrolled on 23 APR 2020.
Pre-assignment details
All enrolled participants were allocated to treatment.
Participants by arm
| Arm | Count |
|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162a1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only as decided by SRC). | 6 |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only as decided by SRC). | 12 |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b1: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), IC expansion cohort. | 15 |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), IC expansion cohort. | 15 |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), alternative posology dose group expansion cohort. | 30 |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), adaptive immune response dose group expansion cohort. | 90 |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) BNT162b2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen), B-cell immune response dose group expansion cohort. | 20 |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (P/B regimen). | 12 |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (SD) BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen). | 12 |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (SD) BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen). | 12 |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg (SD) BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen). | 12 |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (SD) BNT162c2: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (SD regimen). | 12 |
| Total | 512 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 | FG027 | FG028 | FG029 | FG030 | FG031 | FG032 | FG033 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Overall Study | non-trial SARS-COV-2 vaccination due to COVID-19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 2 | 16 | 55 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Pregnancy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Private reason(s) | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Roll-over into trial BNT162-14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 11 | 11 | 10 | 31 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (SD) | BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (SD) | BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg (SD) | BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (SD) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 48.31 years STANDARD_DEVIATION 9.04 | 38.22 years STANDARD_DEVIATION 13.87 | 38.21 years STANDARD_DEVIATION 10.48 | 41.44 years STANDARD_DEVIATION 11.27 | 43.62 years STANDARD_DEVIATION 11.03 | 39.42 years STANDARD_DEVIATION 11.41 | 35.74 years STANDARD_DEVIATION 8.6 | 33.88 years STANDARD_DEVIATION 10.72 | 35.81 years STANDARD_DEVIATION 12.5 | 64.31 years STANDARD_DEVIATION 5.89 | 65.66 years STANDARD_DEVIATION 5.95 | 67.16 years STANDARD_DEVIATION 6.47 | 36.65 years STANDARD_DEVIATION 10.14 | 39.64 years STANDARD_DEVIATION 10.14 | 35.07 years STANDARD_DEVIATION 10.46 | 42.75 years STANDARD_DEVIATION 9.89 | 47.21 years STANDARD_DEVIATION 6.43 | 65.44 years STANDARD_DEVIATION 7.42 | 65.88 years STANDARD_DEVIATION 6.56 | 63.87 years STANDARD_DEVIATION 5.42 | 48.04 years STANDARD_DEVIATION 10.36 | 48.93 years STANDARD_DEVIATION 11.87 | 51.92 years STANDARD_DEVIATION 13.57 | 55.59 years STANDARD_DEVIATION 16.07 | 48.45 years STANDARD_DEVIATION 13.87 | 36.42 years STANDARD_DEVIATION 10.33 | 39.41 years STANDARD_DEVIATION 12.34 | 34.47 years STANDARD_DEVIATION 10.24 | 35.42 years STANDARD_DEVIATION 9.68 | 40.03 years STANDARD_DEVIATION 14.67 | 50.80 years STANDARD_DEVIATION 2.58 | 35.23 years STANDARD_DEVIATION 11.88 | 42.40 years STANDARD_DEVIATION 12.04 | 32.60 years STANDARD_DEVIATION 10.87 | 47.00 years STANDARD_DEVIATION 15.34 |
| Body mass index | 24.23 kg/m^2 STANDARD_DEVIATION 2.78 | 24.73 kg/m^2 STANDARD_DEVIATION 2.63 | 25.17 kg/m^2 STANDARD_DEVIATION 2.89 | 24.94 kg/m^2 STANDARD_DEVIATION 2.68 | 24.20 kg/m^2 STANDARD_DEVIATION 2.32 | 24.34 kg/m^2 STANDARD_DEVIATION 2.33 | 25.68 kg/m^2 STANDARD_DEVIATION 3.44 | 25.52 kg/m^2 STANDARD_DEVIATION 3.5 | 25.19 kg/m^2 STANDARD_DEVIATION 3.09 | 24.73 kg/m^2 STANDARD_DEVIATION 2.46 | 25.59 kg/m^2 STANDARD_DEVIATION 2.22 | 25.63 kg/m^2 STANDARD_DEVIATION 2.22 | 25.25 kg/m^2 STANDARD_DEVIATION 3.26 | 25.50 kg/m^2 STANDARD_DEVIATION 2.79 | 25.13 kg/m^2 STANDARD_DEVIATION 2.07 | 25.43 kg/m^2 STANDARD_DEVIATION 2.34 | 25.01 kg/m^2 STANDARD_DEVIATION 1.38 | 25.43 kg/m^2 STANDARD_DEVIATION 2.15 | 25.62 kg/m^2 STANDARD_DEVIATION 2.47 | 25.85 kg/m^2 STANDARD_DEVIATION 2.75 | 23.62 kg/m^2 STANDARD_DEVIATION 1.9 | 25.63 kg/m^2 STANDARD_DEVIATION 2.82 | 25.53 kg/m^2 STANDARD_DEVIATION 2.72 | 25.08 kg/m^2 STANDARD_DEVIATION 2.73 | 26.12 kg/m^2 STANDARD_DEVIATION 2.96 | 23.31 kg/m^2 STANDARD_DEVIATION 2.38 | 25.02 kg/m^2 STANDARD_DEVIATION 2.85 | 23.83 kg/m^2 STANDARD_DEVIATION 2.39 | 25.06 kg/m^2 STANDARD_DEVIATION 3.73 | 22.82 kg/m^2 STANDARD_DEVIATION 1.54 | 24.61 kg/m^2 STANDARD_DEVIATION 3.14 | 24.97 kg/m^2 STANDARD_DEVIATION 3.17 | 24.19 kg/m^2 STANDARD_DEVIATION 2.04 | 24.04 kg/m^2 STANDARD_DEVIATION 2.59 | 24.98 kg/m^2 STANDARD_DEVIATION 2.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 6 Participants | 11 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 11 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 15 Participants | 15 Participants | 30 Participants | 89 Participants | 20 Participants | 12 Participants | 12 Participants | 10 Participants | 12 Participants | 12 Participants | 12 Participants | 11 Participants | 12 Participants | 12 Participants | 506 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 5 Participants | 12 Participants | 12 Participants | 11 Participants | 11 Participants | 12 Participants | 12 Participants | 11 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 14 Participants | 15 Participants | 30 Participants | 89 Participants | 19 Participants | 11 Participants | 11 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 11 Participants | 12 Participants | 12 Participants | 502 Participants |
| Region of Enrollment Germany | 12 participants | 6 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 15 participants | 15 participants | 30 participants | 90 participants | 20 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants | 512 participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 7 Participants | 6 Participants | 8 Participants | 4 Participants | 4 Participants | 6 Participants | 5 Participants | 5 Participants | 10 Participants | 8 Participants | 5 Participants | 7 Participants | 8 Participants | 10 Participants | 4 Participants | 4 Participants | 6 Participants | 8 Participants | 3 Participants | 9 Participants | 13 Participants | 45 Participants | 10 Participants | 8 Participants | 5 Participants | 3 Participants | 8 Participants | 10 Participants | 5 Participants | 8 Participants | 5 Participants | 7 Participants | 261 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 5 Participants | 6 Participants | 4 Participants | 8 Participants | 8 Participants | 6 Participants | 7 Participants | 7 Participants | 2 Participants | 4 Participants | 7 Participants | 5 Participants | 4 Participants | 2 Participants | 8 Participants | 8 Participants | 6 Participants | 4 Participants | 12 Participants | 6 Participants | 17 Participants | 45 Participants | 10 Participants | 4 Participants | 7 Participants | 9 Participants | 4 Participants | 2 Participants | 7 Participants | 4 Participants | 7 Participants | 5 Participants | 251 Participants |
| Weight | 72.54 kg STANDARD_DEVIATION 10.85 | 78.58 kg STANDARD_DEVIATION 14.93 | 72.99 kg STANDARD_DEVIATION 14.79 | 77.11 kg STANDARD_DEVIATION 14.07 | 71.57 kg STANDARD_DEVIATION 14.09 | 73.58 kg STANDARD_DEVIATION 11.88 | 79.84 kg STANDARD_DEVIATION 13.81 | 76.73 kg STANDARD_DEVIATION 13.32 | 78.70 kg STANDARD_DEVIATION 13.85 | 71.90 kg STANDARD_DEVIATION 10.98 | 70.38 kg STANDARD_DEVIATION 9.14 | 69.98 kg STANDARD_DEVIATION 8.06 | 80.18 kg STANDARD_DEVIATION 14.13 | 77.08 kg STANDARD_DEVIATION 10.84 | 76.11 kg STANDARD_DEVIATION 11.67 | 72.45 kg STANDARD_DEVIATION 10.97 | 77.78 kg STANDARD_DEVIATION 8.43 | 77.87 kg STANDARD_DEVIATION 9.78 | 76.91 kg STANDARD_DEVIATION 12.38 | 75.80 kg STANDARD_DEVIATION 11.98 | 73.85 kg STANDARD_DEVIATION 9.67 | 73.50 kg STANDARD_DEVIATION 10.07 | 77.79 kg STANDARD_DEVIATION 12.92 | 75.44 kg STANDARD_DEVIATION 13.02 | 79.09 kg STANDARD_DEVIATION 14.94 | 67.45 kg STANDARD_DEVIATION 13.53 | 76.41 kg STANDARD_DEVIATION 15.66 | 72.44 kg STANDARD_DEVIATION 6.86 | 70.94 kg STANDARD_DEVIATION 11.43 | 63.75 kg STANDARD_DEVIATION 6.14 | 77.68 kg STANDARD_DEVIATION 7.59 | 73.26 kg STANDARD_DEVIATION 15.39 | 73.48 kg STANDARD_DEVIATION 9.51 | 68.90 kg STANDARD_DEVIATION 11.56 | 74.75 kg STANDARD_DEVIATION 12.27 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk | EG032 affected / at risk | EG033 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 6 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 15 | 0 / 15 | 0 / 30 | 1 / 90 | 0 / 20 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 9 / 12 | 9 / 12 | 5 / 6 | 9 / 12 | 2 / 12 | 12 / 12 | 6 / 12 | 12 / 12 | 12 / 12 | 12 / 12 | 3 / 12 | 4 / 12 | 9 / 12 | 8 / 12 | 7 / 12 | 12 / 12 | 10 / 12 | 11 / 12 | 4 / 12 | 7 / 12 | 4 / 12 | 3 / 15 | 11 / 15 | 13 / 30 | 48 / 90 | 9 / 20 | 4 / 12 | 5 / 12 | 4 / 12 | 2 / 12 | 10 / 12 | 9 / 12 | 5 / 12 | 11 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 6 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 2 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 1 / 12 | 3 / 12 | 0 / 12 | 0 / 15 | 3 / 15 | 0 / 30 | 3 / 90 | 1 / 20 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 1 / 12 |
Outcome results
Primary
Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose.
Solicited local reactions at the injection site (pain, tenderness, erythema/redness, and induration/swelling) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Time frame: From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization)
Population: Safety Set - All subjects who received at least one dose of the IMP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 9 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 3 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 10 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 11 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 6 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 7 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 2 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 6 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 5 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 5 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 10 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 1 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 10 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 12 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 2 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 2 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 4 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 3 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 12 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 2 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 1 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 12 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 7 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 8 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 9 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 11 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 9 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 11 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 6 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 4 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 8 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 9 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 10 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 10 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 11 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 10 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 7 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 1 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 7 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 9 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 8 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 10 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 9 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 1 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 12 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 12 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 14 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 11 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 16 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 2 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 27 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 79 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 1 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 82 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 2 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 19 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 20 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 1 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 3 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 4 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 5 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 3 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 7 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 8 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any local reaction | 8 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 11 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (SD) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (SD) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 4 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (SD) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 7 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (SD) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg (SD) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 5 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg (SD) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (SD) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe/grade >= 3 local reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (SD) | Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any local reaction | 11 Participants |
Primary
Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose.
Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Time frame: From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization)
Population: Safety Set - All subjects who received at least one dose of the IMP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 3 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 6 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 12 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 12 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 4 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 5 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 6 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 3 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 9 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 7 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 7 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 8 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 8 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 5 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 9 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 5 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 10 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 2 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 3 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 6 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 5 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 12 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 5 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 12 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 8 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 2 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 8 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 9 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 10 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 2 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 10 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 2 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 11 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 12 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 4 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 9 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 4 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 2 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 9 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 7 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 10 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 9 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 9 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 3 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 10 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 3 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 4 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 8 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 4 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 11 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 9 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 2 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 4 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 13 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 12 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 14 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 12 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 21 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 4 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 5 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 14 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 78 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 68 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 16 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 15 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 3 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 3 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 5 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 8 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 7 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 6 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 9 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any severe / grade >= 3 systemic reaction | 2 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 12 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Boost up to Day 7 after Boost: Number of participants with any systemic reaction | 9 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 1 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (SD) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 7 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (SD) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (SD) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 2 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (SD) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 7 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg (SD) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 0 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg (SD) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 4 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (SD) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any systemic reaction | 8 Participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (SD) | Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose. | Prime up to Day 7 after Prime: Number of participants with any severe / grade >= 3 systemic reaction | 2 Participants |
Primary
The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2)
TEAEs, without AEs based on solicited reporting via diaries, were analyzed by vaccine, age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade \>=3 TEAE) using the Safety Set.
Time frame: 28 days following Dose 2 or Dose 1 (if no Dose 2 was given)
Population: Safety Set - All participants who received at least one dose of the IMP. Per study protocol, this endpoint was only applicable for arms planned to receive two doses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 17 percentage of participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 33 percentage of participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 83 percentage of participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 58 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 8 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 75 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 25 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 50 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 58 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 67 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 58 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 25 percentage of participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 8 percentage of participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 33 percentage of participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 8 percentage of participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 75 percentage of participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 17 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 58 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 58 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 67 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 8 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 25 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 50 percentage of participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 33 percentage of participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 8 percentage of participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 58 percentage of participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 8 percentage of participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 17 percentage of participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 33 percentage of participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 13 percentage of participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 7 percentage of participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 73 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 3 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 40 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 4 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 49 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 45 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 10 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 33 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 42 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 8 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 33 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any TEAE | 17 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2) | Any grade >=3 TEAE | 8 percentage of participants |
Primary
The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1.
TEAEs without AEs based on solicited reporting via diaries, were analyzed by vaccine, age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade \>=3 TEAE) using the Safety Set.
Time frame: 28 days following Dose 1 or up to Dose 2 (whichever was first)
Population: Safety Set - All participants who received at least one dose of the IMP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 8 percentage of participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 33 percentage of participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 83 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 8 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 50 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 8 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 33 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 42 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 42 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 58 percentage of participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 25 percentage of participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 8 percentage of participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 17 percentage of participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 8 percentage of participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 8 percentage of participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 58 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 25 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 50 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 50 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 8 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 8 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 42 percentage of participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 25 percentage of participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 33 percentage of participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 17 percentage of participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 25 percentage of participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 7 percentage of participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 53 percentage of participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 7 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 13 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 26 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 2 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 5 percentage of participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 14) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 35 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 17 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 33 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 17 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 8 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 3 μg (P/B) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 17 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (SD) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.1 μg (SD) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 50 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (SD) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 58 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.3 μg (SD) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg (SD) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 25 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 0.6 μg (SD) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (SD) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any TEAE | 25 percentage of participants |
| BNT162c2 - Part A Participants Aged 18 to 55 Years - 1 μg (SD) | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1. | Any grade >=3 TEAE | 0 percentage of participants |
Secondary
Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)
At 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization).
Time frame: up to 183 days following Dose 1
Population: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 1.4 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 1.7 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 1.5 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 1.1 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 2.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 5.2 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 13.8 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 2.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 6.3 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 16.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 19.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 11.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 3.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1.4 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 2.7 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 12.4 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 8.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 2.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 36.3 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 2.3 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 32.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 16.5 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 26.9 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 5.5 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 5.8 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 37.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 5.8 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 20.6 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 4.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 23.4 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 11.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 54.7 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 1.8 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 2.7 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 1.5 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 58.7 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 45.3 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 64.0 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 3.4 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 9.2 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 3.3 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 18.0 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 6.7 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 33.9 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 3.1 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 19.0 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 3.9 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 3.3 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 13.8 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 13.1 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 26.9 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 41.5 Fold rise |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 19.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 10.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 1.7 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 7.3 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 7.3 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1.1 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 7.8 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 22.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 26.9 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 13.5 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 6.7 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 2.2 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1.5 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 37.5 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 38.1 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 8.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 4.3 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 29.1 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 3.3 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 3.3 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 32.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 29.3 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 42.7 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 32.9 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 11.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 60.1 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 42.7 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 3.2 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 32.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 7.8 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 65.9 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1.7 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 25.4 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 5.3 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 25.4 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 26.9 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 4.4 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 3.1 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 32.9 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 5.5 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 33.9 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 26.5 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1.6 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.2 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 98.7 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 7.1 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 11.6 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 11.7 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 57.0 Fold rise |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 65.9 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1.0 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 1.0 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 1.1 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 1.0 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 1.0 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 1.0 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 1.0 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 1.0 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1.1 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 1.2 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 1.0 Fold rise |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 1.1 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1.1 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 1.1 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 1.2 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 1.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 1.1 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 1.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 1.6 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 1.1 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 1.2 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 2.1 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1.4 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 1.0 Fold rise |
Secondary
Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B)
At 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization).
Time frame: up to 1 year following Dose 1
Population: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 2 (Day 36) | 41.3 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 2 (Day 43) | 33.5 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 5.4 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 63 days after Dose 2 (Day 85) | 10.1 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 3.5 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 33.5 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 27.2 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 2.4 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 2 (Day 36) | 2.3 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 2.4 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 2.2 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 63 days after Dose 2 (Day 85) | 1.7 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 2 (Day 43) | 2.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 1.1 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 1.1 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 6.1 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 2 (Day 36) | 29.9 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 2 (Day 43) | 24.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 17.5 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 63 days after Dose 2 (Day 85) | 15.8 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 3.8 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 343 days after Dose 2 (Day 365) | 1.4 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 68.4 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 5.8 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 52.3 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 63 days after Dose 2 (Day 85) | 19.6 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 4.3 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 2 (Day 36) | 74.3 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 343 days after Dose 2 (Day 365) | 5.4 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 2 (Day 43) | 60.4 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 20.7 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 1 (Day 15) | 1.9 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 1.3 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 10.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 57.4 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 3.6 Fold rise |
Secondary
Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)
At 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization).
Time frame: up to 183 days following Dose 1
Population: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 21 days after Dose 1 (Day 22) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 42 days after Dose 1 (Day 43) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 84 days after Dose 1 (Day 85) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 183 days after Dose 1 (Day 184) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 84 days after Dose 1 (Day 85) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 21 days after Dose 1 (Day 22) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 183 days after Dose 1 (Day 184) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 42 days after Dose 1 (Day 43) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 28 days after Dose 1 (Day 29) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 84 days after Dose 1 (Day 85) | 1.2 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 28 days after Dose 1 (Day 29) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 183 days after Dose 1 (Day 184) | 1.1 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 21 days after Dose 1 (Day 22) | 1.1 Fold rise |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 42 days after Dose 1 (Day 43) | 1.1 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 183 days after Dose 1 (Day 184) | 1.3 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 21 days after Dose 1 (Day 22) | 1.1 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 28 days after Dose 1 (Day 29) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 42 days after Dose 1 (Day 43) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 84 days after Dose 1 (Day 85) | 1.0 Fold rise |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 7 days after Dose 1 (Day 8) | 1.0 Fold rise |
Secondary
Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)
At Day 1 (Baseline = Pre-Prime Immunization) and at 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization).
Time frame: up to 183 days following Dose 1
Population: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 8.7 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 7.5 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 6.9 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 5.3 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 25.9 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 69.2 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 10.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 10.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 15.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 6.9 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 95.1 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 31.7 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 55.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 80.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 62.2 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 10.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 13.7 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 40.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 82.3 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 181.5 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 11.7 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 160.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 134.5 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 27.4 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 102.9 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 29.2 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 29.1 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 184.9 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 120.5 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.1 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 282.1 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 56.6 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 20.6 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.1 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 13.7 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 8.9 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 7.7 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 5.2 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 320.0 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 226.3 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 293.4 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 16.8 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 46.2 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 16.3 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 15.4 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 89.8 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 19.4 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 169.5 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 33.6 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 95.1 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 95.1 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 134.5 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 207.5 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 16.3 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 69.2 titer |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 65.4 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 36.4 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 5.3 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 8.5 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 36.4 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 38.9 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 49.9 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 33.6 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 7.5 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 11.2 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 134.5 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 109.9 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 67.3 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 16.6 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 190.3 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 21.3 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 187.3 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 40.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 145.6 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 54.8 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 146.7 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 164.7 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 213.6 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 16.3 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 160.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 15.9 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 160.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 213.6 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 38.9 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 300.5 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 329.4 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 127.0 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 26.7 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 8.4 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 134.5 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 127.0 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 21.8 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 169.5 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 7.9 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 27.4 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 164.7 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 132.4 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 15.5 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 678.1 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 80.0 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 8.2 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 49.0 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 452.5 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 6.9 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 391.7 titer |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 58.4 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 5.0 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 5.0 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 5.0 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 5.0 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 5.6 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 5.1 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 5.9 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 5.6 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 5.0 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 5.0 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 5.3 titer |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 5.7 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 5.3 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 5.3 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 5.8 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 7.1 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 5.3 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 10.4 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 5.2 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 8.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 6.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 titer |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 5.0 titer |
Secondary
Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B)
At Day 1 (Baseline = Pre-Prime Immunization) and at 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization).
Time frame: up to 1 year following Dose 1
Population: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 2 (Day 36) | 206.3 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 167.6 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 17.4 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 27.0 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 63 days after Dose 2 (Day 85) | 50.4 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 5.0 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 136.1 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 2 (Day 43) | 167.6 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 11.9 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 5.0 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 5.2 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 12.0 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 2 (Day 36) | 11.5 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 2 (Day 43) | 9.8 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 11.0 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 63 days after Dose 2 (Day 85) | 8.3 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 19.2 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 2 (Day 36) | 149.3 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 2 (Day 43) | 119.9 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 5.4 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 343 days after Dose 2 (Day 365) | 7.1 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 87.7 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 63 days after Dose 2 (Day 85) | 79.1 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 5.7 Titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 30.7 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 63 days after Dose 2 (Day 85) | 99.9 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.1 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 343 days after Dose 2 (Day 365) | 30.2 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 348.6 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 29.5 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 21.9 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 2 (Day 36) | 379.1 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 5.3 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 2 (Day 43) | 307.8 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 266.5 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 17.9 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 1 (Day 15) | 9.5 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 286.8 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 103.3 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | Day 1 (Baseline = Pre-Prime Immunization) | 5.0 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 6.6 Titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 49.8 Titer |
Secondary
Functional Antibody Responses (Titers) for BNT162c2 (SD)
At Day 1 (Baseline = Pre Immunization) and at 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization).
Time frame: up to 183 days following Dose 1
Population: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 183 days after Dose 1 (Day 184) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 21 days after Dose 1 (Day 22) | 5.1 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 42 days after Dose 1 (Day 43) | 5.1 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 84 days after Dose 1 (Day 85) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | Day 1 (Baseline = Pre Immunization) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 84 days after Dose 1 (Day 85) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 28 days after Dose 1 (Day 29) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 42 days after Dose 1 (Day 43) | 5.1 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | Day 1 (Baseline = Pre Immunization) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 21 days after Dose 1 (Day 22) | 5.1 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 183 days after Dose 1 (Day 184) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 28 days after Dose 1 (Day 29) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | Day 1 (Baseline = Pre Immunization) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 21 days after Dose 1 (Day 22) | 5.3 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 42 days after Dose 1 (Day 43) | 5.5 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 84 days after Dose 1 (Day 85) | 6.0 titer |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 183 days after Dose 1 (Day 184) | 5.5 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 21 days after Dose 1 (Day 22) | 5.5 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 183 days after Dose 1 (Day 184) | 6.4 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 84 days after Dose 1 (Day 85) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 7 days after Dose 1 (Day 8) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | Day 1 (Baseline = Pre Immunization) | 5.0 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 42 days after Dose 1 (Day 43) | 5.1 titer |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Functional Antibody Responses (Titers) for BNT162c2 (SD) | 28 days after Dose 1 (Day 29) | 5.2 titer |
Secondary
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)
At 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization).
Time frame: up to 183 days following Dose 1
Population: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 2 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 2 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 1 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 9 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 3 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 2 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 10 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 8 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 6 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 9 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 9 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 3 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 4 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 10 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 10 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 7 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 3 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 7 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 8 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 12 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 7 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 11 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 50 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 10 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 1 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 6 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 3 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 60 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 5 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 12 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 12 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 10 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 5 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 12 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 11 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 7 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 6 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 12 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 8 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 11 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 3 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 10 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 12 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 11 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 12 Participants |
| BNT162b1 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 10 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 7 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 8 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 9 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 3 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 9 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 2 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 9 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 11 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 7 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 1 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 11 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 11 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 6 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 10 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 5 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 11 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 12 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 6 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 11 Participants |
| BNT162b2 - Part A Participants Aged 18 to 55 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 12 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 7 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 12 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 2 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 8 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 12 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 10 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 12 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 11 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 12 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 12 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 7 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 2 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 20 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 4 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 12 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 12 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 12 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 10 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 12 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 10 Participants |
| BNT162b2 - Part A Participants Aged 56 to 85 Years - 30 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 1 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg HIV (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 0 Participants |
| BNT162b2 - Part A IC Participants Aged 18 to 85 Years - 30 μg Post-transplant (Cohort 13) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 1 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 3 & 30 μg (Cohort 11) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 63 days after Dose 2 (Day 85) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 28 days after Dose 2 (Day 50) | 0 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 7 days after Dose 2 (Day 29) | 2 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 1 (Day 22) | 1 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 162 days after Dose 2 (Day 184) | 2 Participants |
| BNT162b2 - Part A Participants Aged 18 to 85 Years - 30 μg (Cohort 12) | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B) | 21 days after Dose 2 (Day 43) | 0 Participants |
Secondary
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B)
At 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization).
Time frame: up to 1 year following Dose 1
Population: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 7 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 15 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 2 (Day 36) | 15 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 2 (Day 43) | 15 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 15 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 63 days after Dose 2 (Day 85) | 13 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 12 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 2 (Day 36) | 4 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 3 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 2 (Day 43) | 3 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 4 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 63 days after Dose 2 (Day 85) | 2 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 4 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 1 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 22 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 12 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 2 (Day 36) | 30 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 2 (Day 43) | 29 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 30 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 343 days after Dose 2 (Day 365) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 63 days after Dose 2 (Day 85) | 28 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 1 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 54 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 61 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 2 (Day 36) | 88 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 1 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 2 (Day 43) | 89 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 88 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 343 days after Dose 2 (Day 365) | 10 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 63 days after Dose 2 (Day 85) | 84 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 89 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 162 days after Dose 2 (Day 184) | 18 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 1 (Day 8) | 2 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 28 days after Dose 2 (Day 50) | 19 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 14 days after Dose 1 (Day 15) | 4 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 21 days after Dose 1 (Day 22) | 9 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B) | 7 days after Dose 2 (Day 29) | 19 Participants |
Secondary
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)
At 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization).
Time frame: up to 183 days following Dose 1
Population: Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 42 days after Dose 1 (Day 43) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 84 days after Dose 1 (Day 85) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 183 days after Dose 1 (Day 184) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 84 days after Dose 1 (Day 85) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 183 days after Dose 1 (Day 184) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 42 days after Dose 1 (Day 43) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 0.3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 28 days after Dose 1 (Day 29) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 84 days after Dose 1 (Day 85) | 1 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 28 days after Dose 1 (Day 29) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 183 days after Dose 1 (Day 184) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 7 days after Dose 1 (Day 8) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162a1 - Part A Participants Aged 18 to 55 Years - 3 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 42 days after Dose 1 (Day 43) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 183 days after Dose 1 (Day 184) | 1 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 21 days after Dose 1 (Day 22) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 28 days after Dose 1 (Day 29) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 42 days after Dose 1 (Day 43) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 84 days after Dose 1 (Day 85) | 0 Participants |
| BNT162b1 - Part A Participants Aged 18 to 55 Years - 1 μg | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD) | 7 days after Dose 1 (Day 8) | 0 Participants |