COVID-19, SARS-CoV-2 Infection
Conditions
Keywords
COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine
Brief summary
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. * 2-dose schedule (separated by 21 days) * At a dose of 30µg (as studied in the Phase 2/3 study C4591001) * In healthy adults 18 through 55 years of age * The duration of the study for each participant will be approximately 2 months (3 visits in total) * The study will be conducted in the United States
Interventions
BIOLOGICALBNT162b2
Intramuscular injection
Sponsors
Pfizer
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female participants 18 - 55 years of age, inclusive, at Visit 1, (Day 1). * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included. * Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol. * For Dose 3: Participants who received BOTH doses of the lyophilized formulation of BNT162b2 as part of the initial study.
Exclusion criteria
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Known infection with HIV, HCV, or HBV. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). * Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19. * Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. * Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * Women who are pregnant or breastfeeding. * Previous vaccination with any coronavirus vaccine. * Receipt of medications intended to prevent COVID-19. * Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. * Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study. * Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation / Previous participation in other studies involving study intervention containing lipid nanoparticles (LNPs). * Previous participation in other studies involving study intervention containing lipid nanoparticles. * Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2 | Dose 1 up to 1 Month after Dose 2 (for approximately 2 months) | 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. |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | 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. |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | 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. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | 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. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1 | Baseline (Before Dose 1 on Day 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. |
| Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1 | From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2 | Baseline (Before Dose 1 on Day 1), 1 Month after Dose 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. |
| GMFRs in Full-length S-binding IgG Levels From Before Dose 3 to 1 Month After Dose 3 | 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. |
| Number of Participants With AEs and SAEs From Dose 3 to 1 Month After Dose 3 | Dose 3 up to 1 Month after Dose 3 (1 month) | 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. |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | 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. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | 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. |
| GMFRs in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 2 | From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 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. |
| GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 279 |
| 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. | 280 |
| 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. | 35 |
| 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. | 35 |
| Total | 629 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Part 1 | Adverse Event | 1 | 1 | 0 | 0 |
| Part 1 | Lost to Follow-up | 2 | 2 | 0 | 0 |
| Part 1 | Protocol Violation | 0 | 1 | 0 | 0 |
| Part 1 | Withdrawal by Subject | 1 | 2 | 0 | 0 |
| Part 2 | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Part 2 | Other | 0 | 0 | 1 | 0 |
| Part 2 | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | BNT162b2 Lyophilized SDV: Part 1 | BNT162b2 Frozen-Liquid MDV: Part 1 | BNT162b2 Frozen-Liquid With LNP Size: Part 2 | BNT162b2 Frozen-Liquid With RTU Size: Part 2 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 279 Participants | 280 Participants | 35 Participants | 35 Participants | 629 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 57 Participants | 55 Participants | 5 Participants | 9 Participants | 126 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 219 Participants | 221 Participants | 30 Participants | 25 Participants | 495 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 0 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 16 Participants | 6 Participants | 3 Participants | 51 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 34 Participants | 2 Participants | 3 Participants | 58 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 228 Participants | 220 Participants | 24 Participants | 28 Participants | 500 Participants |
| Sex: Female, Male Female | 143 Participants | 126 Participants | 20 Participants | 18 Participants | 307 Participants |
| Sex: Female, Male Male | 136 Participants | 154 Participants | 15 Participants | 17 Participants | 322 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 279 | 0 / 280 | 0 / 35 | 0 / 35 | 0 / 114 |
| other Total, other adverse events | 262 / 279 | 274 / 280 | 33 / 35 | 31 / 35 | 87 / 114 |
| serious Total, serious adverse events | 0 / 279 | 0 / 280 | 0 / 35 | 0 / 35 | 0 / 114 |
Outcome results
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.
Time frame: 1 Month after Dose 2
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | 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 | 4796.8 Unit per milliliter |
| BNT162b2 Frozen-Liquid MDV: Part 1 | 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 | 7031.6 Unit per milliliter |
95% CI: [0.6, 0.77]
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.
Time frame: Dose 1 up to 1 Month after Dose 2 (for approximately 2 months)
Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2 | AEs | 16 Participants |
| BNT162b2 Lyophilized SDV: Part 1 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2 | SAEs | 0 Participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2 | SAEs | 0 Participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2 | AEs | 21 Participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2 | AEs | 4 Participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2 | SAEs | 0 Participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2 | AEs | 4 Participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2 | SAEs | 0 Participants |
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.
Time frame: Within 7 days after Dose 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Redness | 4.0 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Pain at Injection Site | 78.1 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Swelling | 3.6 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Redness | 5.0 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Pain at Injection Site | 87.1 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Swelling | 3.6 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Swelling | 0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Redness | 0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Pain at Injection Site | 85.7 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Redness | 2.9 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Pain at Injection Site | 68.6 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Swelling | 5.7 Percentage of participants |
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.
Time frame: Within 7 days after Dose 2
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness | 3.6 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at Injection Site | 71.2 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling | 2.9 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness | 5.5 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at Injection Site | 80.3 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling | 3.3 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling | 0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness | 0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at Injection Site | 71.4 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Redness | 0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Pain at Injection Site | 62.9 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Swelling | 8.6 Percentage of participants |
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.
Time frame: Within 7 days after Dose 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Vomiting | 2.9 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever >=38.0 degree C | 0 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Headache | 31.3 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fatigue | 46.4 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Diarrhea | 14.4 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | New or worsened joint pain | 7.9 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Chills | 8.6 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | New or worsened muscle pain | 16.5 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Headache | 44.3 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever >=38.0 degree C | 3.2 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Diarrhea | 13.9 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | New or worsened muscle pain | 27.1 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fatigue | 57.5 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Chills | 18.6 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Vomiting | 2.1 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | New or worsened joint pain | 15.4 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Headache | 37.1 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Diarrhea | 5.7 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Chills | 8.6 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | New or worsened muscle pain | 11.4 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | New or worsened joint pain | 11.4 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fatigue | 54.3 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Vomiting | 5.7 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever >=38.0 degree C | 0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever >=38.0 degree C | 0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Headache | 31.4 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Chills | 8.6 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | New or worsened joint pain | 17.1 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Vomiting | 2.9 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Diarrhea | 11.4 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | New or worsened muscle pain | 20.0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fatigue | 45.7 Percentage of participants |
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.
Time frame: Within 7 days after Dose 2
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | New or worsened muscle pain | 32.8 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | New or worsened joint pain | 16.8 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever >=38.0 degree C | 6.2 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Headache | 48.2 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Chills | 27.7 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Vomiting | 3.6 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fatigue | 60.9 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Diarrhea | 12.8 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Diarrhea | 14.6 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | New or worsened muscle pain | 43.1 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fatigue | 75.2 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Chills | 46.4 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Vomiting | 2.2 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | New or worsened joint pain | 32.1 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Headache | 61.7 Percentage of participants |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever >=38.0 degree C | 12.4 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Vomiting | 2.9 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Headache | 40.0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Chills | 22.9 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever >=38.0 degree C | 2.9 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | New or worsened muscle pain | 20.0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fatigue | 48.6 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | New or worsened joint pain | 11.4 Percentage of participants |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Diarrhea | 8.6 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | New or worsened joint pain | 28.6 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fatigue | 60.0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Headache | 40.0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Chills | 17.1 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Vomiting | 0 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Diarrhea | 14.3 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | New or worsened muscle pain | 37.1 Percentage of participants |
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever >=38.0 degree C | 5.7 Percentage of participants |
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.
Time frame: Baseline (Before Dose 1 on Day 1)
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1 | 2.2 Unit per milliliter |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1 | 2.2 Unit per milliliter |
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.
Time frame: From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1 | 2189.0 Fold rise |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1 | 3194.0 Fold rise |
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.
Time frame: Baseline, 1 Month after Dose 2, before Dose 3, and 1 Month after Dose 3
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3 | Baseline | 2.1 Unit per milliliter |
| BNT162b2 Lyophilized SDV: Part 1 | GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3 | 1 Month after Dose 2 | 4612.2 Unit per milliliter |
| BNT162b2 Lyophilized SDV: Part 1 | GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3 | Before Dose 3 | 874.4 Unit per milliliter |
| BNT162b2 Lyophilized SDV: Part 1 | GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3 | 1 Month after Dose 3 | 14006.7 Unit per milliliter |
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.
Time frame: Baseline (Before Dose 1 on Day 1), 1 Month after Dose 2
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2 | Baseline | 2.3 Unit per milliliter |
| BNT162b2 Lyophilized SDV: Part 1 | GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2 | 1 Month after Dose 2 | 7773.3 Unit per milliliter |
| BNT162b2 Frozen-Liquid MDV: Part 1 | GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2 | Baseline | 3.3 Unit per milliliter |
| BNT162b2 Frozen-Liquid MDV: Part 1 | GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2 | 1 Month after Dose 2 | 6839.9 Unit per milliliter |
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.
Time frame: From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | GMFRs in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 2 | 3339.1 Fold rise |
| BNT162b2 Frozen-Liquid MDV: Part 1 | GMFRs in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 2 | 2072.1 Fold rise |
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.
Time frame: From before Dose 3 to 1 Month after Dose 3
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | GMFRs in Full-length S-binding IgG Levels From Before Dose 3 to 1 Month After Dose 3 | 16.0 Fold rise |
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.
Time frame: 1 Month after Dose 2
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | 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 | 7773.3 Unit per milliliter |
| BNT162b2 Frozen-Liquid MDV: Part 1 | 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 | 6839.9 Unit per milliliter |
95% CI: [0.77, 1.68]
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.
Time frame: Dose 3 up to 1 Month after Dose 3 (1 month)
Population: Safety population set included all randomized participants who received at least 1 dose of the study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | Number of Participants With AEs and SAEs From Dose 3 to 1 Month After Dose 3 | AEs | 10 Participants |
| BNT162b2 Lyophilized SDV: Part 1 | Number of Participants With AEs and SAEs From Dose 3 to 1 Month After Dose 3 | SAEs | 0 Participants |
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.
Time frame: Within 7 days after Dose 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Redness | 6.5 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Swelling | 6.5 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Pain at Injection Site | 70.1 Percentage of participants |
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.
Time frame: Within 7 days after Dose 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fever >=38.0 degree C | 8.4 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Fatigue | 63.6 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Headache | 52.3 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Chills | 39.3 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Vomiting | 2.8 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Diarrhea | 13.1 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | New or worsened muscle pain | 29.0 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | New or worsened joint pain | 16.8 Percentage of participants |
| BNT162b2 Lyophilized SDV: Part 1 | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Use of antipyretic or pain medication | 35.5 Percentage of participants |