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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate). Additionally, the study will describe the safety and immunogenicity of an additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose schedule of lyophilized BNT162b2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lyophilized SDV | Experimental |
| |
| Frozen liquid MDV (control for lyo SDV) | Experimental | Control for lyophilized SDV |
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| Frozen-liquid with LNP size at the upper end of specification | Experimental |
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| RTU | Experimental |
| |
| Frozen liquid MDV (given as third dose following a primary series of lyophilized BNT162b2) | Experimental | Additional vaccine dose, using the frozen-liquid formulation, offered to participants who originally received 2 doses of the lyophilized formulation of BNT162b2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT162b2 | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Full-Length S-Binding IgG Concentrations of Lyophilized Formulation SDVs and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2 | GMTs of full-length S-binding IgG level for lyophilized formulation in SDVs and frozen-Liquid formulation in MDVs were reported in this outcome measure as geometric mean concentration (GMCs) in descriptive data section. GMC and 95 percent (%) confidence interval (CI) were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Geometric mean ratio (GMR) was calculated as ratios of GMCs of BNT162b2 30 mcg lyophilized SDV and frozen-liquid MDV. GMR are reported in the statistical analysis section. | 1 Month after Dose 2 |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination. | Within 7 days after Dose 1 |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination. | Within 7 days after Dose 2 |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 1 were reported. | Within 7 days after Dose 1 |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1 | GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. | Baseline (Before Dose 1 on Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| GMTs of Full-Length S-Binding IgG Concentrations of Frozen Liquid With LNP Size at Upper End of Specification and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2 | GMTs of full-length S-binding IgG level for frozen liquid with LNP size at upper end of specification relative to frozen-liquid formulation in MDVs were reported in this outcome measure as GMCs in descriptive data section. GMC and 95 % CI were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was calculated as ratios of GMCs of BNT162b2 30 mcg frozen liquid with LNP size at upper end of specification relative to frozen-liquid formulation in MDVs. GMR are reported in the statistical analysis section. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Diablo Clinical Research, Inc. |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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This study was conducted in two parts: Part 1 and Part 2. Participants who received 2 doses of lyophilized formulation of BNT162b2 in Part 1, were offered to receive Dose 3 of frozen-liquid formulation.
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| ID | Title | Description |
|---|---|---|
| FG000 | BNT162b2 Lyophilized Single Dose Vial (SDV): Part 1 | Participants were randomized to receive 30 microgram (mcg) intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine. Participants after receiving 2 doses of lyophilized formulation of BNT162b2 and who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 13, 2021 | Nov 30, 2022 |
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Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 2 were reported. |
| Within 7 days after Dose 2 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2 | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. | Dose 1 up to 1 Month after Dose 2 (for approximately 2 months) |
| Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1 | GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. | From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2 |
| 1 Month after Dose 2 |
| GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2 | GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. | Baseline (Before Dose 1 on Day 1), 1 Month after Dose 2 |
| GMFRs in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 2 | GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. | From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2 |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 3. | Within 7 days after Dose 3 |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 3 were reported. | Within 7 days after Dose 3 |
| Number of Participants With AEs and SAEs From Dose 3 to 1 Month After Dose 3 | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. | Dose 3 up to 1 Month after Dose 3 (1 month) |
| GMFRs in Full-length S-binding IgG Levels From Before Dose 3 to 1 Month After Dose 3 | GMFRs were defined as ratios of the geometric mean concentration of IgG from 1 month after Dose 3 to geometric mean concentration of IgG before Dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. | From before Dose 3 to 1 Month after Dose 3 |
| GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3 | GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. | Baseline, 1 Month after Dose 2, before Dose 3, and 1 Month after Dose 3 |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | United States |
| Research Centers of America ( Hollywood ) | Hollywood | Florida | 33024 | United States |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida | 32256 | United States |
| Clinical Neuroscience Solutions | Orlando | Florida | 32801 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Solaris Clinical Research | Meridian | Idaho | 83646 | United States |
| Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | United States |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | United States |
| Amici Clinical Research LLC | Raritan | New Jersey | 08869 | United States |
| Accellacare (formerly PMG Research of Wilmington, LLC) | Wilmington | North Carolina | 28401 | United States |
| Aventiv Research Inc | Columbus | Ohio | 43213 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| DM Clinical Research (Administrative and Storage Office only) | Tomball | Texas | 77375 | United States |
| Martin Diagnostic Clinic | Tomball | Texas | 77375 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| FG001 | BNT162b2 Frozen-Liquid Multi Dose Vial (MDV): Part 1 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
| FG002 | BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
| FG003 | BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
| Vaccinated at Dose 1 |
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| Vaccinated at Dose 2 |
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| Vaccination at Dose 3 |
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| COMPLETED |
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| NOT COMPLETED |
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| Part 2 |
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Safety population set included all randomized participants who received at least 1 dose of the study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | BNT162b2 Lyophilized SDV: Part 1 | Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3. |
| BG001 | BNT162b2 Frozen-Liquid MDV: Part 1 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
| BG002 | BNT162b2 Frozen-Liquid With LNP Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
| BG003 | BNT162b2 Frozen-Liquid With RTU Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Geometric Mean Titers (GMTs) of Full-Length S-Binding IgG Concentrations of Lyophilized Formulation SDVs and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2 | GMTs of full-length S-binding IgG level for lyophilized formulation in SDVs and frozen-Liquid formulation in MDVs were reported in this outcome measure as geometric mean concentration (GMCs) in descriptive data section. GMC and 95 percent (%) confidence interval (CI) were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Geometric mean ratio (GMR) was calculated as ratios of GMCs of BNT162b2 30 mcg lyophilized SDV and frozen-liquid MDV. GMR are reported in the statistical analysis section. | Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician. | Posted | Geometric Mean | 95% Confidence Interval | Unit per milliliter | 1 Month after Dose 2 |
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| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination. | Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after Dose 1 |
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| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination. | Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after Dose 2 |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 1 were reported. | Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after Dose 1 |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 2 were reported. | Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after Dose 2 |
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| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2 | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. | Safety population set included all randomized participants who received at least 1 dose of the study intervention. | Posted | Count of Participants | Participants | Dose 1 up to 1 Month after Dose 2 (for approximately 2 months) |
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| Secondary | Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1 | GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. | Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Unit per milliliter | Baseline (Before Dose 1 on Day 1) |
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| Secondary | Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1 | GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. | Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2 |
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| Other Pre-specified | GMTs of Full-Length S-Binding IgG Concentrations of Frozen Liquid With LNP Size at Upper End of Specification and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2 | GMTs of full-length S-binding IgG level for frozen liquid with LNP size at upper end of specification relative to frozen-liquid formulation in MDVs were reported in this outcome measure as GMCs in descriptive data section. GMC and 95 % CI were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was calculated as ratios of GMCs of BNT162b2 30 mcg frozen liquid with LNP size at upper end of specification relative to frozen-liquid formulation in MDVs. GMR are reported in the statistical analysis section. | Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician. | Posted | Geometric Mean | 95% Confidence Interval | Unit per milliliter | 1 Month after Dose 2 |
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| Other Pre-specified | GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2 | GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. | Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician. | Posted | Geometric Mean | 95% Confidence Interval | Unit per milliliter | Baseline (Before Dose 1 on Day 1), 1 Month after Dose 2 |
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| Other Pre-specified | GMFRs in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 2 | GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. | Evaluable immunogenicity population: Participants who were eligible and randomized, received 2 doses of vaccine, with Dose 2 received within 19 to 42 days after Dose 1, had at least 1 valid immunogenicity result within 28 to 42 days after Dose 2, were negative for both SARS-CoV-2 tests at both Day 1 and 1 month post-Dose 2 visits, and had no other important protocol deviations as determined by clinician. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2 |
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| Other Pre-specified | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after Dose 3. | Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after Dose 3 |
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| Other Pre-specified | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Systemic events were reported using an electronic diary. Fever was defined as temperature >=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 3 were reported. | Safety population set included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after Dose 3 |
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| Other Pre-specified | Number of Participants With AEs and SAEs From Dose 3 to 1 Month After Dose 3 | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. | Safety population set included all randomized participants who received at least 1 dose of the study intervention. | Posted | Count of Participants | Participants | Dose 3 up to 1 Month after Dose 3 (1 month) |
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| Other Pre-specified | GMFRs in Full-length S-binding IgG Levels From Before Dose 3 to 1 Month After Dose 3 | GMFRs were defined as ratios of the geometric mean concentration of IgG from 1 month after Dose 3 to geometric mean concentration of IgG before Dose 3. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. | Evaluable immunogenicity population:Participants who were eligible and randomized,received 2 doses of lyophilized SDV,with Dose 2 received within 19 to 42 days after Dose 1,received Dose 3 of frozen liquid MDV,had at least 1 valid immunogenicity result within 28 to 42 days after Dose 3,were negative for both SARS-CoV-2 tests at Day 1 and 1 month post-Dose 3 visits, and had no other important protocol deviations as determined by clinician. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | From before Dose 3 to 1 Month after Dose 3 |
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| Other Pre-specified | GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3 | GMCs of full-length S-binding IgG levels were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. | Evaluable immunogenicity population:Participants eligible and randomized,received 2 doses of lyophilized SDV,with Dose 2 received within 19 to 42 days after Dose 1,received Dose 3 of frozen liquid MDV,had at least 1 valid immunogenicity result within 28 to 42 days after Dose 3,negative for both SARS-CoV-2 tests at Day 1,1 month post Dose 3 visits, had no other important protocol deviations determined by clinician. Here, n= participants evaluable for specific timepoint. | Posted | Geometric Mean | 95% Confidence Interval | Unit per milliliter | Baseline, 1 Month after Dose 2, before Dose 3, and 1 Month after Dose 3 |
|
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AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BNT162b2 Lyophilized SDV: Part 1 | Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3. | 0 | 279 | 0 | 279 | 262 | 279 |
| EG001 | BNT162b2 Frozen-Liquid MDV: Part 1 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. | 0 | 280 | 0 | 280 | 274 | 280 |
| EG002 | BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. | 0 | 35 | 0 | 35 | 33 | 35 |
| EG003 | BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. | 0 | 35 | 0 | 35 | 31 | 35 |
| EG004 | BNT162b2 Frozen-Liquid MDV: Dose 3 | Participants who originally received 2 doses of lyophilized SDV formulation of BNT162b2 30 mcg in Part 1 of the study were administered with an additional dose of frozen liquid MDV of BNT162b2 30 mcg at least 3 months after Dose 2. Participants were followed up for safety for 1 month after third dose of vaccine. | 0 | 114 | 0 | 114 | 87 | 114 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Bacterial vulvovaginitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Tonsillar inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Diarrhoea (DIARRHEA) | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Vomiting (VOMITING) | Gastrointestinal disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Chills (CHILLS) | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Fatigue (FATIGUE) | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Injection site erythema (REDNESS) | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Injection site pain (PAIN) | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Injection site swelling (SWELLING) | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Arthralgia (JOINT PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Myalgia (MUSCLE PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Systematic Assessment |
| |
| Headache (HEADACHE) | Nervous system disorders | MedDRA v25.0 | Systematic Assessment |
|
BioNTech SE has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BioNTech clinical trials patient information | BioNTech SE | +49 6131 9084 | 0 | patients@biontech.de |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 5, 2021 | Nov 30, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 |
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
| OG003 | BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
|
|
| OG002 |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 |
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
| OG003 | BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
|
|
| OG002 | BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
| OG003 | BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
|
|
| OG002 | BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
| OG003 | BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
|
|
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
| OG002 | BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
| OG003 | BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
|
|
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine.
|
|
| OG001 |
| BNT162b2 Frozen-Liquid MDV: Part 1 |
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
|
|
| OG001 |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 |
Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. |
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