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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003267-26 | EudraCT Number | ||
| U1111-1254-4840 | Other Identifier | WHO Universal Trial Number (UTN) |
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Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was skipped due to changes in the overall clinical development plan. The conducted Part A was a dose-finding part to investigate the optimal dose, allowing dose adjustments upwards and downwards in younger participants. Doses tested in older participants were chosen based on acceptability of dosing in younger participants.
This study was a multi-site, Phase I/II, open-label, dose-escalation study. The study included the first in human dose and dose ranging groups in healthy younger participants (aged 18 to 55 years [yrs]) and older participants (aged 56 to 85 yrs). The conducted Part A followed a dose escalation design. Discretionary dose de-escalation and refinement was also planned. Study participants with the first-in-human [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 (screening to Visit 7) and a follow-up phase (Visits 8 to 10).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A participants aged 18 to 55 years | Experimental | Escalating dose levels |
|
| Part A participants aged 56 to 85 years (optional) | Experimental | Escalating dose levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT162b3 | Biological | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost (P/B) regimen). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day 1 to Day 8 for Prime Immunization and from Day 22 to Day 29 for Boost Immunization |
| 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. | From Day 1 to Day 8 for Prime Immunization and from Day 22 to Day 29 for Boost Immunization |
| The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Prime Immunization up to Boost Immunization or 28 Days After Prime Immunization | Treatment emergent adverse events (TEAEs) were analyzed by age group, dose level, and for each IMP dose. The number and 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. | 28 days following first IMP dose or up to second IMP dose (whichever was first) |
| The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring up to 28 Days After Boost Immunization or After Prime Immunization (if no Boost Immunization) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Antibody Responses | At 7 and 21 days after primary immunization and at 7, 14, 21, 28 days after boost immunization. | up to 50 days following first IMP dose |
| Fold Increase in Functional Antibody Titers |
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Inclusion Criteria:
OR For older adult cohorts, volunteers must be aged 56 to 85 years, have a body mass index over 19 kg/m^2 and under 30 kg/m^2 (i.e., be neither underweight nor obese), and weigh at least 50 kg at Visit 0.
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 participants 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 participants 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 immunosuppressants or other immune-modifying drugs, 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 participant safety.
Received 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 IMP including vaccines within 60 days or 5 half-lives (whichever is longer), prior to Visit 0.
Have a known history or a positive test of any of human immunodeficiency virus (HIV) 1 or 2, Hepatitis B, or Hepatitis C, within the 30 days prior to Visit 0.
Have a positive polymerase chain reaction (PCR)-based test for severe acute respiratory syndrome coronavirus 2 (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.
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 participants 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.
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.
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, participants in detention, contract research organization (CRO) or sponsor staff or their family members.
Regular receipt of inhaled/nebulized corticosteroids.
Have a condition known to put them at high risk for severe COVID-19, including those with any of the following risk factors:
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| Name | Affiliation | Role |
|---|---|---|
| BioNTech Responsible Person | BioNTech SE | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contract Research Organization | Berlin | Germany | ||||
| Contract Research Organization |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41530185 | Derived | Vogel AB, Lui BG, Tompkins K, Kanevsky I, Muik A, Krumm SA, Guler A, Maddur MS, Walzer KC, Witzel S, Vascotto F, Stanganello E, Ota-Setlik A, Cottingham KJ, Allbritton O, Keverne J, Aragao-Santiago L, Swanson KA, Tureci O, Sahin U. Strong and early immune responses against SARS-CoV-2 in mice and rhesus macaques after BNT162b3 vaccination. NPJ Vaccines. 2026 Jan 13;11(1):10. doi: 10.1038/s41541-025-01365-w. |
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All enrolled participants were allocated to treatment.
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 09 Sep 2020. The last visit of the last participant was on 07 Feb 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A Participants Aged 18 to 55 Years - 3 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| FG001 | Part A Participants Aged 18 to 55 Years - 10 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| FG002 | Part A Participants Aged 18 to 55 Years - 20 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| FG003 | Part A Participants Aged 18 to 55 Years - 30 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee). |
| FG004 | Part A Participants Aged 56 to 85 Years - 3 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| FG005 | Part A Participants Aged 56 to 85 Years - 10 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| FG006 | Part A Participants Aged 56 to 85 Years - 20 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| FG007 | Part A Participants Aged 56 to 85 Years - 30 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
| ||||||||||||||||||
| Follow-up Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A Participants Aged 18 to 55 Years - 3 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| BG001 | Part A Participants Aged 18 to 55 Years - 10 μg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Set - All participants who received at least one dose of the IMP. | Posted | Count of Participants | Participants | No | From Day 1 to Day 8 for Prime Immunization and from Day 22 to Day 29 for Boost Immunization |
|
Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1 [Prime Immunization]) up to Day 387 (approximately 12 months after Dose 2 [Boost Immunization]); Other AEs in participants with Dose 2: All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 387; Other AEs in participants without Dose 2: All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 387.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A Participants Aged 18 to 55 Years - 3 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BioNTech clinical trials patient information | BioNTech SE | +49 6131 9084 | 0 | patients@biontech.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 12, 2021 | Feb 6, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2022 | Feb 1, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Treatment emergent adverse events (TEAEs) were analyzed by 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. |
| 28 days following second IMP dose or first IMP dose (if no second IMP dose as given) |
At 7 and 21 days after primary immunization and at 7, 14, 21, and 28 days after the boost immunization.
| up to 50 days following first IMP dose |
| Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline | At 7 and 21 days after primary immunization and at 7, 14, 21, and 28 days after the boost immunization. | up to 50 days following first IMP dose |
| Functional Antibody Responses | At 63, 162, 365 days after boost immunization. | From 51 to up to 387 days following first IMP dose |
| Fold Increase in Functional Antibody Titers | At 63, 162, 365 days after boost immunization. | From 51 to up to 387 days following first IMP dose |
| Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline | At 63, 162, 365 days after boost immunization. | From 51 to up to 387 days following first IMP dose |
| Mannheim |
| Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| BG002 | Part A Participants Aged 18 to 55 Years - 20 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| BG003 | Part A Participants Aged 18 to 55 Years - 30 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee) |
| BG004 | Part A Participants Aged 56 to 85 Years - 3 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| BG005 | Part A Participants Aged 56 to 85 Years - 10 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| BG006 | Part A Participants Aged 56 to 85 Years - 20 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| BG007 | Part A Participants Aged 56 to 85 Years - 30 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
| OG001 | Part A Participants Aged 18 to 55 Years - 10 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| OG002 | Part A Participants Aged 18 to 55 Years - 20 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| OG003 | Part A Participants Aged 18 to 55 Years - 30 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee) |
| OG004 | Part A Participants Aged 56 to 85 Years - 3 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| OG005 | Part A Participants Aged 56 to 85 Years - 10 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| OG006 | Part A Participants Aged 56 to 85 Years - 20 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
| OG007 | Part A Participants Aged 56 to 85 Years - 30 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) |
|
|
| 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. | Safety Set - All participants who received at least one dose of the IMP. | Posted | Count of Participants | Participants | No | From Day 1 to Day 8 for Prime Immunization and from Day 22 to Day 29 for Boost Immunization |
|
|
|
| Primary | The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Prime Immunization up to Boost Immunization or 28 Days After Prime Immunization | Treatment emergent adverse events (TEAEs) were analyzed by age group, dose level, and for each IMP dose. The number and 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. | Safety Set - All participants who received at least one dose of the IMP. | Posted | Number | percentage of participants | 28 days following first IMP dose or up to second IMP dose (whichever was first) |
|
|
|
| Primary | The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring up to 28 Days After Boost Immunization or After Prime Immunization (if no Boost Immunization) | Treatment emergent adverse events (TEAEs) were analyzed by 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. | Safety Set - All participants who received at least one dose of the IMP. | Posted | Number | percentage of participants | 28 days following second IMP dose or first IMP dose (if no second IMP dose as given) |
|
|
|
| Secondary | Functional Antibody Responses | At 7 and 21 days after primary immunization and at 7, 14, 21, 28 days after boost immunization. | Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. | Posted | Geometric Mean | 95% Confidence Interval | titer | up to 50 days following first IMP dose |
|
|
|
| Secondary | Fold Increase in Functional Antibody Titers | At 7 and 21 days after primary immunization and at 7, 14, 21, and 28 days after the boost immunization. | Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | up to 50 days following first IMP dose |
|
|
|
| Secondary | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline | At 7 and 21 days after primary immunization and at 7, 14, 21, and 28 days after the boost immunization. | Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. | Posted | Count of Participants | Participants | No | up to 50 days following first IMP dose |
|
|
|
| Secondary | Functional Antibody Responses | At 63, 162, 365 days after boost immunization. | Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. Day 387 (365 days after boost) data is either missing due to exclusion because of non-study vaccination or due to premature discontinuation. | Posted | Geometric Mean | 95% Confidence Interval | titer | From 51 to up to 387 days following first IMP dose |
|
|
|
| Secondary | Fold Increase in Functional Antibody Titers | At 63, 162, 365 days after boost immunization. | Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. Day 387 (365 days after boost) data is either missing due to exclusion because of non-study vaccination or due to premature discontinuation. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | From 51 to up to 387 days following first IMP dose |
|
|
|
| Secondary | Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline | At 63, 162, 365 days after boost immunization. | Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment. Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision. Day 387 (365 days after boost) data is either missing due to exclusion because of non-study vaccination or due to premature discontinuation. | Posted | Count of Participants | Participants | From 51 to up to 387 days following first IMP dose |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 7 |
| 12 |
| EG001 | Part A Participants Aged 18 to 55 Years - 10 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) | 0 | 12 | 0 | 12 | 4 | 12 |
| EG002 | Part A Participants Aged 18 to 55 Years - 20 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) | 0 | 12 | 0 | 12 | 5 | 12 |
| EG003 | Part A Participants Aged 18 to 55 Years - 30 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee) | 0 | 12 | 1 | 12 | 6 | 12 |
| EG004 | Part A Participants Aged 56 to 85 Years - 3 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) | 0 | 12 | 0 | 12 | 7 | 12 |
| EG005 | Part A Participants Aged 56 to 85 Years - 10 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) | 0 | 12 | 0 | 12 | 5 | 12 |
| EG006 | Part A Participants Aged 56 to 85 Years - 20 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) | 0 | 12 | 0 | 12 | 5 | 12 |
| EG007 | Part A Participants Aged 56 to 85 Years - 30 μg | BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) | 0 | 12 | 0 | 12 | 6 | 12 |
| Ear pain | Ear and labyrinth disorders | MedDRA (23.1) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (23.1) | Systematic Assessment |
|
| Meibomian gland dysfunction | Eye disorders | MedDRA (23.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Dental care | Surgical and medical procedures | MedDRA (23.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
PIs respectively trial sites shall not publish or refer to in writing or orally, in whole or in part, any data, information or materials generated from the study and the services, without the prior written consent of the sponsor.
| D003333 |
| Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
|
|
|
|
| Prime up to Day 7 after Prime: Number of participants with any grade >= 3 systemic reaction |
|
|
| Boost up to Day 7 after Boost: Number of participants with any systemic reaction |
|
|
| Boost up to Day 7 after Boost: Number of participants with any grade >= 3 systemic reaction |
|
|
| Any grade >=3 TEAE |
|
| Any grade >=3 TEAE |
|
| 21 days after Prime Immunization (Day 22) |
|
| 7 days after Boost Immunization (Day 29) |
|
| 14 days after Boost Immunization (Day 36) |
|
| 21 days after Boost Immunization (Day 43) |
|
| 28 days after Boost Immunization (Day 50) |
|
|
| 21 days after Prime Immunization (Day 22) |
|
|
| 7 days after Boost Immunization (Day 29) |
|
|
| 14 days after Boost Immunization (Day 36) |
|
|
| 21 days after Boost Immunization (Day 43) |
|
|
| 28 days after Boost Immunization (Day 50) |
|
|
|
| 21 days after Prime Immunization (Day 22) |
|
|
| 7 days after Boost Immunization (Day 29) |
|
|
| 14 days after Boost Immunization (Day 36) |
|
|
| 21 days after Boost Immunization (Day 43) |
|
|
| 28 days after Boost Immunization (Day 50) |
|
|
|
| 162 days after Boost Immunization (Day 184) |
|
|
| 365 days after Boost Immunization (Day 387) |
|
|
|
| 162 days after Boost Immunization (Day 184) |
|
|
| 365 days after Boost Immunization (Day 387) |
|
|
|
| 162 days after Boost Immunization (Day 184) |
|
|
| 365 days after Boost Immunization (Day 387) |
|
|