SARS-CoV-2
Conditions
Keywords
Protection against COVID-19, Coronavirus Disease 2019, Coronavirus infection, Vaccine, RNA Vaccine, Virus Diseases
Brief summary
This was a phase I, randomized, placebo-controlled, observer-blind study, for evaluation of safety and immunogenicity of SARS-CoV-2 mRNA vaccine (BNT162b1) in Chinese healthy population.
Detailed description
The participants were screened for 2 weeks (Day -14 to Day 0) before randomization, and received 1 dose of SARS-CoV-2 vaccine (BNT162b1) or placebo intramuscularly (IM) on Day 1 and Day 22, respectively. After randomization, the study for each participant lasted for approximately 12 months.
Interventions
BIOLOGICALBNT162b1
Intramuscular injection
OTHERPlacebo
Intramuscular injection
Sponsors
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
For adult group (age ≥18 and ≤55) * Male or female subjects of ≥18 years old and ≤55 years old with body mass index (BMI) ≥18 and ≤30 at the Screening Visit. * Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination (including vital signs, electrocardiogram \[ECG\]) and eligibility screening test (hematology, blood chemistry and urine analysis) and clinical judgment of the investigator at Screening Visit. * The subject can provide with informed consent and signs and dates a written informed consent form (ICF) prior to the initiation of any trial procedures. * They must be able to understand and follow trial-related instructions. * They must be willing and able to comply with planned visits, treatment schedule, laboratory tests and other requirements of the trial. * Negative in antibodies screening of SARS-CoV-2 (fingerstick). * Normal in chest computed tomography (CT) scans (no imaging features of COVID-19). * Axillary temperature ≤ 37.0ºC. * Negative SARS-CoV-2 test in throat swabs by reverse transcription-polymerase chain reaction (RT-PCR). * Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) in serum sample at Screening Visit. Women that are postmenopausal (Menopause≥12 consecutive months) or permanently sterilized will be considered as not having reproductive potential. * WOCBP must have used effective contraception 14 days prior to screening and agree to use effective contraception continuously during the trial period, from 14 days prior to Screening Visit to 60 days after the last immunization. * WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting from Screening Visit and continuously until 60 days after being given the last immunization. * Men who are sexually active with a WOCBP and have not had a vasectomy must agree to practice an effective form of contraception with their female partner of childbearing potential during the trial, starting from Screening Visit and continuously until 60 days after being given the last immunization. * Men must be willing to refrain from sperm donation, starting from Screening Visit and continuously until 60 days after receiving the last immunization. For the elderly group (age ≥65 and ≤85) * Male or female subjects ≥65 years old and ≤85 years old at Screening Visit * Individuals who are in a health condition that can receive the investigational vaccine, at the time of entry into the trial as determined by medical history, physical examination (including vital signs, ECG) and eligibility screening tests (hematology, biochemistry and urinalysis) and clinical judgment of the investigator at Screening Visit. * The subject can provide with informed consent and signs and dates a written ICF prior to the initiation of any trial procedures. * They must be able to understand and follow trial-related instructions. * They must be willing and able to comply with planned visits, treatment schedule, laboratory tests and other requirements of the trial. * Negative in antibodies screening of SARS-CoV-2 (blood sample from fingertip). * No imaging features of COVID-19 in chest CT. * Axillary temperature ≤ 37.0ºC. * Negative SARS-CoV-2 test in throat swabs by RT-PCR. * WOCBP must have a negative serum β-hCG at Screening Visit. Women that are postmenopausal (Menopause ≥12 consecutive months) or permanently sterilized will be considered as not having reproductive potential. * WOCBP must have used effective contraception 14 days prior to screening and agree to use effective contraception continuously during the trial period, from 14 days prior to Screening Visit to 60 days after the last immunization. * WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting from Screening Visit and continuously until 60 days after being given the last immunization. * Men who are sexually active with a WOCBP and have not had a vasectomy must agree to practice an effective form of contraception with their female partner of childbearing potential during the trial, starting from Screening Visit and continuously until 60 days after being given the last immunization. * Men must be willing to refrain from sperm donation, starting from Screening Visit and continuously until 60 days after receiving the last immunization.
Exclusion criteria
For adult group (age ≥18 and ≤55) * Have had any acute illness, as determined by the investigator, with or without fever, within 72 hours prior to the prime vaccination. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the investigator, the residual symptoms will not compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. * Are breastfeeding on the day of Screening Visit or who plan to breastfeed during the trial, starting from Screening Visit and continuously until at least 90 days after the last immunization. Women or partners who plan to become pregnant within 1 year post the Screening Visit. * Have a known allergy, hypersensitivity, or intolerance to the planned vaccine for trial including any excipients. * Used to have a history of hypersensitivity or serious reactions to vaccination. * Received any vaccination within 4 weeks prior to Visit 1. * Don't agree to not be vaccinated during the trial, starting from Screening Visit and continuously until 28 days after receiving the last immunization, except emergency vaccination (e.g. rabies vaccine, tetanus vaccine). * Had any medical condition (e.g., autoimmune disease) or any major surgery (e.g., requiring general anesthesia) within the past 5 years, which in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. * Have any surgery planned during the trial, starting from Screening Visit and continuously until at least 90 days after the last immunization. * Had any chronic use (more than 14 continuous days) of any systemic medications that affects immune function, including immunosuppressant or other immune-modifying drugs, within 6 months prior to Screening Visit unless in the opinion of the investigator, the medication would not prevent, limit, or confound the protocol-specified assessments or could compromise safety of subjects. * Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Screening Visit. * Had administration of another investigational product including vaccines within 60 days or 5 half-lives (whichever is longer), prior to Screening Visit. * With known history of AIDS or human immunodeficiency virus (HIV) test positive. * History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, through medical inquiry. * History of SARS, SARS-CoV-2 or middle east respiratory syndrome (MERS) infection. Suspected SARS patients should be screened for SARS antibodies. * Previously participated in a clinical trial involving lipid nanoparticles. * Are subject to exclusion periods of other clinical trials or simultaneous participation in another clinical trial. * Have any affiliation with the study site (e.g., are close relative of the investigator or dependent person, such as an employee or student of the study site). * Have a history of drug abuse or known medical, psychological, or social conditions within the past 5 years. In the opinion of the investigator, could comprise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. * Have a history of narcolepsy. * Have history of alcohol abuse or drug addiction within 1 year prior to Screening Visit. * Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Screening Visit. * Have any abnormality or permanent body art (e.g., tattoo), that in the opinion of the investigator, would obstruct the ability to observe local reactions at the vaccination site. * Have had any blood loss \>400 mL, e.g., due to donation of blood or blood products or injury, within the 28 days prior to Screening Visit or plan to donate blood or plasma during the trial, starting from Screening Visit and continuously until at least 28 days after being given the last immunization. * Travel or live in any country or region with a high SARS-CoV-2 infection risk (as defined at Screening Visit) within the 14 days prior to Screening Visit. * They plan to visit any country or region with a high SARS-CoV-2 infection risk (as defined at Screening Visit), from Screening Visit until 14 days after being given the last immunization. * Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. * Have had contact with confirmed COVID-19 patients or persons tested positive for SARS-CoV-2 within the 30 days prior to Screening Visit. * Are vulnerable persons, e.g., soldiers, subjects in detention, contract research organization (CRO) or Fosun staff or their family members. For the elderly group (age ≥65 and ≤85) * Baseline laboratory abnormalities with Grade ≥3 (for hematology abnormalities with Grade ≥2) during screening visits, by physical examination and eligibility screening. * Have had any acute illness, as determined by the investigator, with or without fever, within 72 hours prior to the prime vaccination. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the investigator, the residual symptoms will not compromise their well-being if they participate as trial subjects in the trial, or that will not prevent, limit, or confound the protocol-specified assessments. * Have a known allergy, hypersensitivity, or intolerance to the planned vaccine for trial including any excipients. * Used to have a history of hypersensitivity or serious reactions to vaccination. * Received any vaccination within 4 weeks prior to Visit 1. * Don't agree to not be vaccinated during the trial, starting from Screening Visit and continuously until 28 days after receiving the last immunization, except emergency vaccination (e.g. rabies vaccine, tetanus vaccine). * Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Screening Visit. * Had any serious or life-threatening medical condition (e.g., autoimmune disease, cardiovascular disease) within the past 5 years, which in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. * Have any surgery planned during the trial, starting from Screening Visit and continuously until at least 90 days after the last immunization. * Had any chronic use (more than 14 continuous days) of any systemic medications that affects immune function, including immunosuppressant or other immune-modifying drugs, within 6 months prior to Screening Visit unless in the opinion of the investigator, the medication would not prevent, limit, or confound the protocol-specified assessments or could compromise safety of subjects. * Had administration of another investigational product including vaccines within 60 days or 5 half-lives (whichever is longer), prior to Screening Visit. * With known history of AIDS or HIV test positive. * History of HBV or HCV infection. * History of SARS, SARS-CoV-2 or MERS infection. Suspected SARS patients should be screened for SARS antibodies. * Previously participated in a clinical trial involving lipid nanoparticles. * Are subject to exclusion periods of other clinical trials or simultaneous participation in another clinical trial. * Have any affiliation with the study site (e.g., are close relative of the investigator or dependent person, such as an employee or student of the study site). * Have a history of drug abuse or known medical, psychological, or social conditions within the past 5 years. In the opinion of the investigator, could comprise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. * Have a history of narcolepsy. * Have history of alcohol abuse or drug addiction within 1 year prior to Screening Visit. * Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Screening Visit. * Have any abnormality or permanent body art (e.g., tattoo), that in the opinion of the investigator, would obstruct the ability to observe local reactions at the vaccination site. * Have had any blood loss \>400 mL, e.g., due to donation of blood or blood products or injury, within the 28 days prior to Screening Visit or plan to donate blood or plasma during the trial, starting from Screening Visit and continuously until at least 28 days after being given the last immunization. * Travel or live in any country or region with a high SARS-CoV-2 infection risk (as defined at Screening Visit) within the 14 days prior to Screening Visit. * They plan to visit any country or region with a high SARS-CoV-2 infection risk (as defined at Screening Visit), from Screening Visit until 14 days after being given the last immunization. * Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. * Have had contact with confirmed COVID-19 patients or persons tested positive for SARS-CoV-2 nucleic acids or antibodies within the 30 days prior to Screening Visit. * Are vulnerable persons, e.g., soldiers, subjects in detention, CRO or Fosun staff or their family members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Up to 14 days following each dose administration | Solicited local AEs were collected within 7 days/14 days after each vaccination. For the grading of AEs, a 7-day period AE assessment after each dose as graded by United States (US) Food and Drug Administration (FDA) criteria along with the 14-day period AE assessment as graded by National Medical Products Administration (NMPA) criteria are used to evaluate solicited AEs. For other AEs, only the NMPA criteria is used. The solicited AEs were pre-defined and listed in the subjects' diaries. All the solicited local AEs occurred within 7 days after vaccination were related to investigational vaccine (or placebo). |
| Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Up to 14 days following each dose administration | Solicited systemic AEs were collected within 7 days/14 days after each vaccination. For the grading of AEs, a 7-day period AE assessment after each dose as graded by US FDA criteria along with the 14-day period AE assessment as graded by NMPA criteria are used to evaluate solicited AEs. For other AEs, only the NMPA criteria is used. The solicited AEs were pre-defined and listed in the subjects' diaries. Except for 1 event (myalgia) occurred in 10 µg group and 1 event (diarrhea) occurred in placebo group, all the solicited systemic AEs occurred within 7 days after vaccination were related to investigational vaccine (or placebo). All the solicited systemic AEs occurred within 14 days after vaccination were related to investigational vaccine (or placebo), except for 1 event (myalgia) occurred in placebo group and 2 events (both diarrhea; 1 event occurred in 30 µg group, 1 event occurred in placebo group). |
| Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo. | 21-day period after dose 1 vaccination | AEs occurred during the 21-day period after dose 1 were also referred as unsolicited AEs. The unsolicited AEs were not pre-defined in the subjects' diaries. |
| Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo. | 28-day period after dose 2 vaccination | AEs occurred during the 28-day period after dose 2 were also referred as unsolicited AEs. The unsolicited AEs were not pre-defined in the subjects' diaries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Up to 12 months following first dose | At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6 and 12 after dose 1. |
| GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Up to 12 months following first dose | At Day 7, Day 21 after first dose, at Day 7, Day 21 after second dose, and at Month 3, 6, and 12 after first dose. |
| Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Up to 12 months following the first dose | At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6, and 12 after dose 1. |
| The Number of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) | From Dose 1 up to Month 12 | — |
| Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Up to 12 months following first dose | At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6, and 12 after dose 1. |
| Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | Up to 21 days after dose 2 | At Day 7, Day 21 after dose 1, and at Day 7, Day 21 after dose 2. |
| Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Up to 12 months following first dose | At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6, and 12 after dose 1. |
| The Number of Participants Experiencing Related TEAEs | From Dose 1 up to Month 12 | Related implies the relationship between AE and vaccine is one of Possibly related, Probably related and Definitely related. |
| The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | Hour 24 and Day 7 after dose 1 and Day 7 after dose 2 | Results for CS results are displayed by abnormal parameter. Abnormal test results assessed not clinical significant are not presented. Participants with more than one 'CS' parameter are counted for each parameter separately and therefore included multiple times. |
| Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Up to 12 months following first dose | At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6 and 12 after dose 1. |
Countries
China
Participant flow
Recruitment details
A total of 144 subjects were randomized in this phase I clinical trial, including 72 adult subjects aged 18-55 years old (including boundary value) and 72 elderly subjects aged 65-85 years old (including boundary value). The subjects received either BNT162b1 10 µg (low dose), BNT162b1 30 µg (high dose), or placebo on Day 1 and Day 22, respectively.
Pre-assignment details
All enrolled participants were allocated to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Low-dose 10 µg, 18-55 Years of Age BNT162b1: Intramuscular injection | 24 |
| High-dose 30 µg, 18-55 Years of Age BNT162b1: Intramuscular injection | 24 |
| Placebo, 18-55 Years of Age Placebo: Intramuscular injection | 24 |
| Low-dose 10 µg, 65-85 Years of Age BNT162b1: Intramuscular injection | 24 |
| High-dose 30 µg, 65-85 Years of Age BNT162b1: Intramuscular injection | 24 |
| Placebo, 65-85 Years of Age Placebo: Intramuscular injection | 24 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Received 2 Doses | Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 | 0 |
| Received 2 Doses and Completed Follow-up | Adverse Event | 0 | 0 | 0 | 1 | 1 | 0 |
| Received 2 Doses and Completed Follow-up | inoculated with other COVID-19 vaccine | 1 | 0 | 1 | 0 | 0 | 0 |
| Received 2 Doses and Completed Follow-up | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Low-dose 10 µg, 18-55 Years of Age | High-dose 30 µg, 18-55 Years of Age | Placebo, 18-55 Years of Age | Low-dose 10 µg, 65-85 Years of Age | High-dose 30 µg, 65-85 Years of Age | Placebo, 65-85 Years of Age | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 24 Participants | 24 Participants | 24 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 24 Participants | 24 Participants | 0 Participants | 0 Participants | 0 Participants | 72 Participants |
| Age, Continuous Group, 18-55 years of age | 38 years STANDARD_DEVIATION 9.6 | 40 years STANDARD_DEVIATION 9 | 42 years STANDARD_DEVIATION 8.7 | — | — | — | 40 years STANDARD_DEVIATION 9.2 |
| Age, Continuous Group, 65-85 years of age | — | — | — | 71 years STANDARD_DEVIATION 5 | 69 years STANDARD_DEVIATION 3 | 71 years STANDARD_DEVIATION 4.4 | 70 years STANDARD_DEVIATION 4.2 |
| Body mass index (BMI) Group 18-55 years of age | 24.7 kg/m^2 STANDARD_DEVIATION 3.18 | 23.0 kg/m^2 STANDARD_DEVIATION 2.71 | 24.3 kg/m^2 STANDARD_DEVIATION 3.43 | — | — | — | 24.0 kg/m^2 STANDARD_DEVIATION 3.16 |
| Body mass index (BMI) Group 65-85 years of age | — | — | — | 23.9 kg/m^2 STANDARD_DEVIATION 2.95 | 24.8 kg/m^2 STANDARD_DEVIATION 2.85 | 23.5 kg/m^2 STANDARD_DEVIATION 2.45 | 24.1 kg/m^2 STANDARD_DEVIATION 2.77 |
| Race/Ethnicity, Customized Asian | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 144 Participants |
| Region of Enrollment China | 24 participants | 24 participants | 24 participants | 24 participants | 24 participants | 24 participants | 144 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 72 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 72 Participants |
| Weight Group 18-55 years of age | 69.5 kg STANDARD_DEVIATION 12.05 | 62.8 kg STANDARD_DEVIATION 10.75 | 65.7 kg STANDARD_DEVIATION 13.26 | — | — | — | 66.0 kg STANDARD_DEVIATION 12.21 |
| Weight Group 65-85 years of age | — | — | — | 61.8 kg STANDARD_DEVIATION 9.83 | 63.8 kg STANDARD_DEVIATION 8.81 | 59.0 kg STANDARD_DEVIATION 8.36 | 61.5 kg STANDARD_DEVIATION 9.11 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 22 / 24 | 24 / 24 | 7 / 24 | 22 / 24 | 24 / 24 | 9 / 24 |
| serious Total, serious adverse events | 0 / 24 | 1 / 24 | 1 / 24 | 1 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo.
Solicited local AEs were collected within 7 days/14 days after each vaccination. For the grading of AEs, a 7-day period AE assessment after each dose as graded by United States (US) Food and Drug Administration (FDA) criteria along with the 14-day period AE assessment as graded by National Medical Products Administration (NMPA) criteria are used to evaluate solicited AEs. For other AEs, only the NMPA criteria is used. The solicited AEs were pre-defined and listed in the subjects' diaries. All the solicited local AEs occurred within 7 days after vaccination were related to investigational vaccine (or placebo).
Time frame: Up to 14 days following each dose administration
Population: Safety Analysis Set including all randomized participants who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 1: Number of participants with solicited local AEs | 19 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 2: Number of participants with solicited local AEs | 17 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 1: Number of participants with solicited local AEs grade 3 (FDA criteria) | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 2: Number of participants with solicited local AEs grade 3 (FDA criteria) | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 days after dose 1: Number of participants with solicited local AEs grade 3 (NMPA criteria) | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 days after dose 2: Number of participants with solicited local AEs grade 3 (NMPA criteria) | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 days after dose 2: Number of participants with solicited local AEs grade 3 (NMPA criteria) | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 1: Number of participants with solicited local AEs grade 3 (FDA criteria) | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 2: Number of participants with solicited local AEs | 20 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 2: Number of participants with solicited local AEs grade 3 (FDA criteria) | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 days after dose 1: Number of participants with solicited local AEs grade 3 (NMPA criteria) | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 1: Number of participants with solicited local AEs | 24 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 days after dose 2: Number of participants with solicited local AEs grade 3 (NMPA criteria) | 0 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 2: Number of participants with solicited local AEs grade 3 (FDA criteria) | 0 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 2: Number of participants with solicited local AEs | 1 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 1: Number of participants with solicited local AEs grade 3 (FDA criteria) | 0 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 days after dose 1: Number of participants with solicited local AEs grade 3 (NMPA criteria) | 0 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 1: Number of participants with solicited local AEs | 1 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 days after dose 2: Number of participants with solicited local AEs grade 3 (NMPA criteria) | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 days after dose 1: Number of participants with solicited local AEs grade 3 (NMPA criteria) | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 2: Number of participants with solicited local AEs | 15 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 1: Number of participants with solicited local AEs grade 3 (FDA criteria) | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 2: Number of participants with solicited local AEs grade 3 (FDA criteria) | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 1: Number of participants with solicited local AEs | 13 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 days after dose 1: Number of participants with solicited local AEs grade 3 (NMPA criteria) | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 days after dose 2: Number of participants with solicited local AEs grade 3 (NMPA criteria) | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 2: Number of participants with solicited local AEs | 15 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 1: Number of participants with solicited local AEs grade 3 (FDA criteria) | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 2: Number of participants with solicited local AEs grade 3 (FDA criteria) | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 1: Number of participants with solicited local AEs | 19 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 1: Number of participants with solicited local AEs grade 3 (FDA criteria) | 0 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 1: Number of participants with solicited local AEs | 0 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 2: Number of participants with solicited local AEs | 0 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 days after dose 2: Number of participants with solicited local AEs grade 3 (NMPA criteria) | 0 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 days after dose 2: Number of participants with solicited local AEs grade 3 (FDA criteria) | 0 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 days after dose 1: Number of participants with solicited local AEs grade 3 (NMPA criteria) | 0 Participants |
Primary
Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo.
Solicited systemic AEs were collected within 7 days/14 days after each vaccination. For the grading of AEs, a 7-day period AE assessment after each dose as graded by US FDA criteria along with the 14-day period AE assessment as graded by NMPA criteria are used to evaluate solicited AEs. For other AEs, only the NMPA criteria is used. The solicited AEs were pre-defined and listed in the subjects' diaries. Except for 1 event (myalgia) occurred in 10 µg group and 1 event (diarrhea) occurred in placebo group, all the solicited systemic AEs occurred within 7 days after vaccination were related to investigational vaccine (or placebo). All the solicited systemic AEs occurred within 14 days after vaccination were related to investigational vaccine (or placebo), except for 1 event (myalgia) occurred in placebo group and 2 events (both diarrhea; 1 event occurred in 30 µg group, 1 event occurred in placebo group).
Time frame: Up to 14 days following each dose administration
Population: Safety Analysis Set including all randomized participants who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 2: Number of participants with solicited systemic AEs | 15 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (FDA) | 1 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (FDA) | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (NMPA) | 3 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 1: Number of participants with solicited systemic AEs | 10 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (NMPA) | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 2: Number of participants with solicited systemic AEs | 15 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d (days) after dose 1: Number of participants with solicited systemic AEs | 9 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 2: Number of participants with solicited systemic AEs | 21 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (NMPA) | 5 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d (days) after dose 1: Number of participants with solicited systemic AEs | 16 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 2: Number of participants with solicited systemic AEs | 21 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 1: Number of participants with solicited systemic AEs | 16 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (NMPA) | 6 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (FDA) | 1 Participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (FDA) | 3 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d (days) after dose 1: Number of participants with solicited systemic AEs | 3 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 2: Number of participants with solicited systemic AEs | 3 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (NMPA) | 0 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 2: Number of participants with solicited systemic AEs | 3 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (FDA) | 0 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (NMPA) | 0 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (FDA) | 0 Participants |
| Placebo, 18-55 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 1: Number of participants with solicited systemic AEs | 3 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (NMPA) | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (NMPA) | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 2: Number of participants with solicited systemic AEs | 7 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 1: Number of participants with solicited systemic AEs | 3 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 2: Number of participants with solicited systemic AEs | 7 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d (days) after dose 1: Number of participants with solicited systemic AEs | 3 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (FDA) | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (FDA) | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (FDA) | 2 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (NMPA) | 2 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (FDA) | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 2: Number of participants with solicited systemic AEs | 17 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 1: Number of participants with solicited systemic AEs | 15 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 2: Number of participants with solicited systemic AEs | 17 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (NMPA) | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d (days) after dose 1: Number of participants with solicited systemic AEs | 15 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (NMPA) | 0 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d (days) after dose 1: Number of participants with solicited systemic AEs | 2 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 2: Number of participants with solicited systemic AEs | 1 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 1: Number of participants with solicited systemic AEs | 2 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 2: Number of participants with solicited systemic AEs | 2 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (FDA) | 0 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 7 d after dose 2: Number of participants with related solicited systemic AEs grade 3 (FDA) | 0 Participants |
| Placebo, 65-85 Years of Age | Number of Participants With Solicited Systemic AEs (e.g., e.g., Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo. | Within 14 d after dose 1: Number of participants with related solicited systemic AEs grade 3 (NMPA) | 0 Participants |
Primary
Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo.
AEs occurred during the 21-day period after dose 1 were also referred as unsolicited AEs. The unsolicited AEs were not pre-defined in the subjects' diaries.
Time frame: 21-day period after dose 1 vaccination
Population: Safety Analysis Set including all randomized participants who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo. | 7 participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo. | 7 participants |
| Placebo, 18-55 Years of Age | Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo. | 1 participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo. | 2 participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo. | 5 participants |
| Placebo, 65-85 Years of Age | Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo. | 2 participants |
Primary
Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo.
AEs occurred during the 28-day period after dose 2 were also referred as unsolicited AEs. The unsolicited AEs were not pre-defined in the subjects' diaries.
Time frame: 28-day period after dose 2 vaccination
Population: Safety Analysis Set including all randomized participants who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo. | 5 participants |
| High-dose 30 µg, 18-55 Years of Age | Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo. | 8 participants |
| Placebo, 18-55 Years of Age | Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo. | 0 participants |
| Low-dose 10 µg, 65-85 Years of Age | Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo. | 2 participants |
| High-dose 30 µg, 65-85 Years of Age | Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo. | 7 participants |
| Placebo, 65-85 Years of Age | Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo. | 0 participants |
Secondary
Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline
At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6, and 12 after dose 1.
Time frame: Up to 12 months following first dose
Population: Per Protocol Set (PPS) - all subjects in the Total Vaccinated Cohort (TVC) who had no major protocol violations and completed dose 2. The TVC included all randomized subjects who had received at least one dose of the investigational vaccine/placebo and could provide with effective baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 7 days after dose 1 | 1.000 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 12 after dose 1 | 46.481 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 3 after dose 1 | 804.724 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 6 after dose 1 | 164.992 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 7 days after dose 2 | 766.291 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 21 days after dose 1 | 261.903 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 21 days after dose 2 | 994.206 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 7 days after dose 1 | 1.001 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 21 days after dose 2 | 969.249 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 12 after dose 1 | 53.098 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 21 days after dose 1 | 246.976 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 6 after dose 1 | 181.895 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 7 days after dose 2 | 895.886 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 3 after dose 1 | 814.977 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 12 after dose 1 | 0.970 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 7 days after dose 1 | 0.985 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 21 days after dose 1 | 0.986 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 7 days after dose 2 | 0.998 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 21 days after dose 2 | 1.054 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 3 after dose 1 | 1.051 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 6 after dose 1 | 1.061 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 12 after dose 1 | 25.871 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 7 days after dose 2 | 182.382 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 21 days after dose 1 | 51.597 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 6 after dose 1 | 69.813 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 21 days after dose 2 | 797.173 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 21 days after dose 2 | 741.532 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 7 days after dose 2 | 556.487 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 12 after dose 1 | 41.548 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 21 days after dose 1 | 150.858 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 6 after dose 1 | 104.557 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 6 after dose 1 | 0.764 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | Month 12 after dose 1 | 0.835 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 7 days after dose 2 | 1.020 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 21 days after dose 1 | 1.001 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in Antibody Anti-RBD IgG Antibody Titers, as Compared to Baseline | 21 days after dose 2 | 0.884 fold rise |
Secondary
Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline
At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6, and 12 after dose 1.
Time frame: Up to 12 months following the first dose
Population: Per Protocol Set (PPS) - all subjects in the Total Vaccinated Cohort (TVC) who had no major protocol violations and completed dose 2. The TVC included all randomized subjects who had received at least one dose of the investigational vaccine/placebo and could provide with effective baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 7 days after dose 1 | 0.960 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 7 days after dose 2 | 478.186 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 3 after dose 1 | 488.888 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 21 days after dose 2 | 843.129 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 12 after dose 1 | 35.898 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 6 after dose 1 | 75.098 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 21 days after dose 1 | 75.535 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 7 days after dose 1 | 0.998 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 3 after dose 1 | 532.172 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 21 days after dose 1 | 76.351 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 12 after dose 1 | 47.053 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 6 after dose 1 | 95.924 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 7 days after dose 2 | 699.755 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 21 days after dose 2 | 838.640 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 7 days after dose 2 | 0.987 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 6 after dose 1 | 1.028 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 7 days after dose 1 | 0.992 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 12 after dose 1 | 0.936 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 3 after dose 1 | 0.939 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 21 days after dose 1 | 0.988 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 21 days after dose 2 | 0.939 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 6 after dose 1 | 42.685 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 12 after dose 1 | 21.169 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 21 days after dose 1 | 16.501 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 7 days after dose 2 | 101.189 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 21 days after dose 2 | 785.911 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 21 days after dose 2 | 805.108 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 7 days after dose 2 | 427.484 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 21 days after dose 1 | 52.377 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 12 after dose 1 | 51.688 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 6 after dose 1 | 90.619 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 12 after dose 1 | 0.842 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 21 days after dose 1 | 0.997 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 7 days after dose 2 | 1.003 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | 21 days after dose 2 | 0.977 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in Antibody Anti-S1 IgG Antibody Titers, as Compared to Baseline | Month 6 after dose 1 | 0.966 fold rise |
Secondary
Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline.
At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6, and 12 after dose 1.
Time frame: Up to 12 months following first dose
Population: Per Protocol Set (PPS) - all subjects in the Total Vaccinated Cohort (TVC) who had no major protocol violations and completed dose 2. The TVC included all randomized subjects who had received at least one dose of the investigational vaccine/placebo and could provide with effective baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 3 after dose 1 | 10.992 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 21 days after dose 1 | 3.775 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 7 days after dose 2 | 11.314 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 12 after dose 1 | 1.572 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 21 days after dose 2 | 46.581 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 7 days after dose 1 | 1.000 fold rise |
| Low-dose 10 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 6 after dose 1 | 3.268 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 12 after dose 1 | 2.378 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 3 after dose 1 | 17.448 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 21 days after dose 2 | 50.797 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 6 after dose 1 | 5.496 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 21 days after dose 1 | 2.911 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 7 days after dose 2 | 23.973 fold rise |
| High-dose 30 µg, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 7 days after dose 1 | 1.000 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 6 after dose 1 | 1.000 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 7 days after dose 2 | 1.000 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 7 days after dose 1 | 1.000 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 21 days after dose 2 | 1.000 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 12 after dose 1 | 1.000 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 3 after dose 1 | 1.000 fold rise |
| Placebo, 18-55 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 21 days after dose 1 | 1.000 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 21 days after dose 2 | 16.000 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 21 days after dose 1 | 1.393 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 7 days after dose 2 | 2.871 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 6 after dose 1 | 2.000 fold rise |
| Low-dose 10 µg, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 12 after dose 1 | 1.208 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 6 after dose 1 | 4.122 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 21 days after dose 1 | 2.189 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 12 after dose 1 | 2.416 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 7 days after dose 2 | 9.879 fold rise |
| High-dose 30 µg, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 21 days after dose 2 | 32.000 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 21 days after dose 1 | 1.000 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 6 after dose 1 | 1.000 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 7 days after dose 2 | 1.000 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | Month 12 after dose 1 | 1.000 fold rise |
| Placebo, 65-85 Years of Age | Fold Increase in SARS-CoV-2 Neutralizing Antibody Titers (Virus Neutralizing Test), as Compared to Baseline. | 21 days after dose 2 | 1.000 fold rise |
Secondary
Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody
At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6 and 12 after dose 1.
Time frame: Up to 12 months following first dose
Population: Per Protocol Set (PPS) - all subjects in the Total Vaccinated Cohort (TVC) who had no major protocol violations and completed dose 2. The TVC included all randomized subjects who had received at least one dose of the investigational vaccine/placebo and could provide with effective baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 7 days after dose 1 | 53.320 titer |
| Low-dose 10 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 6 after dose 1 | 4169.448 titer |
| Low-dose 10 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 21 days after dose 1 | 4193.710 titer |
| Low-dose 10 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 3 after dose 1 | 27143.015 titer |
| Low-dose 10 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 7 days after dose 2 | 26548.853 titer |
| Low-dose 10 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 21 days after dose 2 | 46810.469 titer |
| Low-dose 10 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 12 after dose 1 | 2002.152 titer |
| High-dose 30 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 7 days after dose 1 | 59.220 titer |
| High-dose 30 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 6 after dose 1 | 5693.082 titer |
| High-dose 30 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 21 days after dose 2 | 49773.381 titer |
| High-dose 30 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 21 days after dose 1 | 4531.416 titer |
| High-dose 30 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 12 after dose 1 | 2792.605 titer |
| High-dose 30 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 3 after dose 1 | 31584.450 titer |
| High-dose 30 µg, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 7 days after dose 2 | 41530.498 titer |
| Placebo, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 7 days after dose 2 | 52.578 titer |
| Placebo, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 7 days after dose 1 | 52.841 titer |
| Placebo, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 21 days after dose 1 | 52.594 titer |
| Placebo, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 6 after dose 1 | 55.088 titer |
| Placebo, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 12 after dose 1 | 50.000 titer |
| Placebo, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 21 days after dose 2 | 50.000 titer |
| Placebo, 18-55 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 3 after dose 1 | 50.000 titer |
| Low-dose 10 µg, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 12 after dose 1 | 1104.860 titer |
| Low-dose 10 µg, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 21 days after dose 2 | 40942.862 titer |
| Low-dose 10 µg, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 6 after dose 1 | 2223.699 titer |
| Low-dose 10 µg, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 21 days after dose 1 | 859.646 titer |
| Low-dose 10 µg, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 7 days after dose 2 | 5271.560 titer |
| High-dose 30 µg, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 21 days after dose 2 | 44159.581 titer |
| High-dose 30 µg, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 21 days after dose 1 | 2872.861 titer |
| High-dose 30 µg, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 7 days after dose 2 | 23447.197 titer |
| High-dose 30 µg, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 6 after dose 1 | 4970.376 titer |
| High-dose 30 µg, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 12 after dose 1 | 2847.010 titer |
| Placebo, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 21 days after dose 2 | 61.008 titer |
| Placebo, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 7 days after dose 2 | 62.658 titer |
| Placebo, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | 21 days after dose 1 | 62.239 titer |
| Placebo, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 12 after dose 1 | 53.105 titer |
| Placebo, 65-85 Years of Age | Geometric Mean Titer (GMT) of Anti-S1 IgG Antibody | Month 6 after dose 1 | 60.931 titer |
Secondary
GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody
At Day 7, Day 21 after dose 1, at Day 7, Day 21 after dose 2, and at Month 3, 6 and 12 after dose 1.
Time frame: Up to 12 months following first dose
Population: Per Protocol Set (PPS) - all subjects in the Total Vaccinated Cohort (TVC) who had no major protocol violations and completed dose 2. The TVC included all randomized subjects who had received at least one dose of the investigational vaccine/placebo and could provide with effective baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 3 after dose 1 | 40236.195 titer |
| Low-dose 10 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 21 days after dose 1 | 13095.167 titer |
| Low-dose 10 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 7 days after dose 2 | 38314.550 titer |
| Low-dose 10 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 12 after dose 1 | 2324.072 titer |
| Low-dose 10 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 21 days after dose 2 | 49710.291 titer |
| Low-dose 10 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 7 days after dose 1 | 50.000 titer |
| Low-dose 10 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 6 after dose 1 | 8249.604 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 12 after dose 1 | 2804.882 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 3 after dose 1 | 43050.715 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 21 days after dose 2 | 51200.000 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 6 after dose 1 | 9608.488 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 21 days after dose 1 | 13046.378 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 7 days after dose 2 | 47324.691 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 7 days after dose 1 | 52.903 titer |
| Placebo, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 6 after dose 1 | 61.768 titer |
| Placebo, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 7 days after dose 2 | 57.377 titer |
| Placebo, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 7 days after dose 1 | 56.644 titer |
| Placebo, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 21 days after dose 2 | 60.605 titer |
| Placebo, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 12 after dose 1 | 56.083 titer |
| Placebo, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 3 after dose 1 | 60.439 titer |
| Placebo, 18-55 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 21 days after dose 1 | 56.699 titer |
| Low-dose 10 µg, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 21 days after dose 2 | 46980.825 titer |
| Low-dose 10 µg, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 21 days after dose 1 | 3040.808 titer |
| Low-dose 10 µg, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 7 days after dose 2 | 10748.566 titer |
| Low-dose 10 µg, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 6 after dose 1 | 4114.353 titer |
| Low-dose 10 µg, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 12 after dose 1 | 1536.143 titer |
| High-dose 30 µg, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 6 after dose 1 | 7187.827 titer |
| High-dose 30 µg, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 21 days after dose 1 | 10370.854 titer |
| High-dose 30 µg, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 12 after dose 1 | 2768.366 titer |
| High-dose 30 µg, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 7 days after dose 2 | 38256.083 titer |
| High-dose 30 µg, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 21 days after dose 2 | 50977.162 titer |
| Placebo, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 21 days after dose 1 | 74.476 titer |
| Placebo, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 6 after dose 1 | 54.780 titer |
| Placebo, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 7 days after dose 2 | 75.817 titer |
| Placebo, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | Month 12 after dose 1 | 63.175 titer |
| Placebo, 65-85 Years of Age | GMT of Anti-receptor Binding Domain (RBD) Immunoglobulin G (IgG) Antibody | 21 days after dose 2 | 65.756 titer |
Secondary
GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test)
At Day 7, Day 21 after first dose, at Day 7, Day 21 after second dose, and at Month 3, 6, and 12 after first dose.
Time frame: Up to 12 months following first dose
Population: Per Protocol Set (PPS) - all subjects in the Total Vaccinated Cohort (TVC) who had no major protocol violations and completed dose 2. The TVC included all randomized subjects who had received at least one dose of the investigational vaccine/placebo and could provide with effective baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 3 after dose 1 | 54.958 titer |
| Low-dose 10 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 21 days after dose 1 | 18.877 titer |
| Low-dose 10 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 7 days after dose 2 | 56.569 titer |
| Low-dose 10 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 12 after dose 1 | 7.858 titer |
| Low-dose 10 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 21 days after dose 2 | 232.905 titer |
| Low-dose 10 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 7 days after dose 1 | 5.000 titer |
| Low-dose 10 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 6 after dose 1 | 16.339 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 12 after dose 1 | 11.892 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 3 after dose 1 | 87.241 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 21 days after dose 2 | 253.984 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 6 after dose 1 | 27.479 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 21 days after dose 1 | 14.557 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 7 days after dose 2 | 119.865 titer |
| High-dose 30 µg, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 7 days after dose 1 | 5.000 titer |
| Placebo, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 6 after dose 1 | 5.000 titer |
| Placebo, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 7 days after dose 2 | 5.000 titer |
| Placebo, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 7 days after dose 1 | 5.000 titer |
| Placebo, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 21 days after dose 2 | 5.000 titer |
| Placebo, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 12 after dose 1 | 5.000 titer |
| Placebo, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 3 after dose 1 | 5.000 titer |
| Placebo, 18-55 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 21 days after dose 1 | 5.000 titer |
| Low-dose 10 µg, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 21 days after dose 2 | 80.000 titer |
| Low-dose 10 µg, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 21 days after dose 1 | 6.965 titer |
| Low-dose 10 µg, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 7 days after dose 2 | 14.357 titer |
| Low-dose 10 µg, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 6 after dose 1 | 10.000 titer |
| Low-dose 10 µg, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 12 after dose 1 | 6.040 titer |
| High-dose 30 µg, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 6 after dose 1 | 20.612 titer |
| High-dose 30 µg, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 21 days after dose 1 | 10.946 titer |
| High-dose 30 µg, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 12 after dose 1 | 12.081 titer |
| High-dose 30 µg, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 7 days after dose 2 | 49.394 titer |
| High-dose 30 µg, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 21 days after dose 2 | 160.000 titer |
| Placebo, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 21 days after dose 1 | 5.000 titer |
| Placebo, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 6 after dose 1 | 5.000 titer |
| Placebo, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 7 days after dose 2 | 5.000 titer |
| Placebo, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | Month 12 after dose 1 | 5.000 titer |
| Placebo, 65-85 Years of Age | GMT of SARS-CoV-2 Neutralizing Antibody (Including True Virus-based SARS-CoV-2 Neutralizing Test) | 21 days after dose 2 | 5.000 titer |
Secondary
Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline
At Day 7, Day 21 after dose 1, and at Day 7, Day 21 after dose 2.
Time frame: Up to 21 days after dose 2
Population: Per Protocol Set (PPS) - all subjects in the Total Vaccinated Cohort (TVC) who had no major protocol violations and completed dose 2. The TVC included all randomized subjects who had received at least one dose of the investigational vaccine/placebo and could provide with effective baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 2 | 24 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 7 days after dose 2 | 18 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 7 days after dose 2 | 24 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 21 days after dose 2 | 24 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 1 | 12 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 7 days after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 21 days after dose 1 | 24 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 21 days after dose 2 | 24 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 7 days after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 7 days after dose 2 | 24 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 21 days after dose 1 | 24 Participants |
| Low-dose 10 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 7 days after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 7 days after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 21 days after dose 1 | 24 Participants |
| High-dose 30 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 21 days after dose 1 | 24 Participants |
| High-dose 30 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 7 days after dose 2 | 23 Participants |
| High-dose 30 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 7 days after dose 2 | 24 Participants |
| High-dose 30 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 1 | 11 Participants |
| High-dose 30 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 7 days after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 7 days after dose 2 | 24 Participants |
| High-dose 30 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 2 | 24 Participants |
| High-dose 30 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 7 days after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 21 days after dose 2 | 24 Participants |
| High-dose 30 µg, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 21 days after dose 2 | 24 Participants |
| Placebo, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 7 days after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 21 days after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 7 days after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 7 days after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 7 days after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 21 days after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 21 days after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 7 days after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 21 days after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 7 days after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 2 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 2 | 21 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 21 days after dose 1 | 21 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 7 days after dose 2 | 23 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 7 days after dose 2 | 22 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 21 days after dose 2 | 23 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 21 days after dose 1 | 22 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 21 days after dose 2 | 23 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 1 | 3 Participants |
| Low-dose 10 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 7 days after dose 2 | 11 Participants |
| High-dose 30 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 21 days after dose 1 | 22 Participants |
| High-dose 30 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 21 days after dose 2 | 23 Participants |
| High-dose 30 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 21 days after dose 2 | 23 Participants |
| High-dose 30 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 7 days after dose 2 | 23 Participants |
| High-dose 30 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 2 | 22 Participants |
| High-dose 30 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 1 | 8 Participants |
| High-dose 30 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 7 days after dose 2 | 18 Participants |
| High-dose 30 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 21 days after dose 1 | 22 Participants |
| High-dose 30 µg, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 7 days after dose 2 | 23 Participants |
| Placebo, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 21 days after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 7 days after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 21 days after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 21 days after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 7 days after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-RBD IgG antibody - 7 days after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of anti-S1 IgG antibody - 21 days after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | Seroconversion Rates (SCR) Defined as a Minimum of 4-fold Increase of Antibody Titers, as Compared to Baseline | SCR of SARS-CoV-2 neutralizing antibody - 21 days after dose 2 | 0 Participants |
Secondary
The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis
Results for CS results are displayed by abnormal parameter. Abnormal test results assessed not clinical significant are not presented. Participants with more than one 'CS' parameter are counted for each parameter separately and therefore included multiple times.
Time frame: Hour 24 and Day 7 after dose 1 and Day 7 after dose 2
Population: The safety analysis set included all randomized subjects who receive at least one dose of the investigational vaccine/placebo and have at least one safety evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - Day 7 after dose 1 | 1 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - 24 hours after dose 1 | 1 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - Day 7 after dose 2 | 1 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - 24 hours after dose 1 | 3 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - Day 7 after dose 2 | 1 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - Day 7 after dose 1 | 1 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - 24 hours after dose 1 | 1 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - 24 hours after dose 1 | 2 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - 24 hours after dose 1 | 5 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - Day 7 after dose 2 | 1 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - Day 7 after dose 2 | 1 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - 24 hours after dose 1 | 1 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - 24 hours after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - Day 7 after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - 24 hours after dose 1 | 1 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - Day 7 after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - 24 hours after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - Day 7 after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - Day 7 after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - Day 7 after dose 1 | 1 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - 24 hours after dose 1 | 1 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - 24 hours after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - 24 hours after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - Day 7 after dose 2 | 2 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - 24 hours after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - 24 hours after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - Day 7 after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - Day 7 after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - Day 7 after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - 24 hours after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - Day 7 after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - Day 7 after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - Day 7 after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - 24 hours after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - Day 7 after dose 1 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - Day 7 after dose 2 | 0 Participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 2 | 1 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - 24 hours after dose 1 | 1 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 2 | 1 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 1 | 1 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - Day 7 after dose 1 | 1 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 1 | 1 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - Day 7 after dose 2 | 1 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - Day 7 after dose 2 | 1 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - Day 7 after dose 2 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - 24 hours after dose 1 | 0 Participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - Day 7 after dose 1 | 1 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - Day 7 after dose 1 | 1 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - 24 hours after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - Day 7 after dose 2 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - 24 hours after dose 1 | 2 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - Day 7 after dose 1 | 0 Participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - Day 7 after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - Day 7 after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - 24 hours after dose 1 | 1 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - 24 hours after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - Day 7 after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - blood - 24 hours after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - Day 7 after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - Day 7 after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - Day 7 after dose 1 | 1 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - ketone - 24 hours after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - Day 7 after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - Day 7 after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - glucose - 24 hours after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - 24 hours after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - lymphocyte - Day 7 after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - Day 7 after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - red blood cells (microscopic) - 24 hours after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal blood chemistry parameter - increased total bilirubin - Day 7 after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - 24 hours after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - Day 7 after dose 1 | 1 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - bacteria (microscopic) - 24 hours after dose 1 | 1 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal urine routine test results - elevated leucocyte (microscopic) - Day 7 after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - Day 7 after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - Day 7 after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - 24 hours after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - platelet count - Day 7 after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hematocrit - Day 7 after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - Day 7 after dose 2 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - Day 7 after dose 1 | 0 Participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Clinically Significant (CS) Abnormal Markers of Hematology, Blood Chemistry and Urine Analysis | CS abnormal hematology parameter - hemoglobin - 24 hours after dose 1 | 0 Participants |
Secondary
The Number of Participants Experiencing Related TEAEs
Related implies the relationship between AE and vaccine is one of Possibly related, Probably related and Definitely related.
Time frame: From Dose 1 up to Month 12
Population: Safety Analysis Set including all randomized subjects who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Related TEAEs | Number of Participants with related TEAEs after dose 1 | 22 participants |
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Related TEAEs | Number of Participants with related TEAEs after dose 2 | 20 participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Related TEAEs | Number of Participants with related TEAEs after dose 1 | 24 participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Related TEAEs | Number of Participants with related TEAEs after dose 2 | 22 participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Related TEAEs | Number of Participants with related TEAEs after dose 1 | 4 participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Related TEAEs | Number of Participants with related TEAEs after dose 2 | 4 participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Related TEAEs | Number of Participants with related TEAEs after dose 1 | 16 participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Related TEAEs | Number of Participants with related TEAEs after dose 2 | 18 participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Related TEAEs | Number of Participants with related TEAEs after dose 1 | 21 participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Related TEAEs | Number of Participants with related TEAEs after dose 2 | 21 participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Related TEAEs | Number of Participants with related TEAEs after dose 1 | 4 participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Related TEAEs | Number of Participants with related TEAEs after dose 2 | 0 participants |
Secondary
The Number of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From Dose 1 up to Month 12
Population: Safety Analysis Set including all randomized subjects who receive at least one dose of the investigational vaccine/placebo and at least one safety evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low-dose 10 µg, 18-55 Years of Age | The Number of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) | 0 participants |
| High-dose 30 µg, 18-55 Years of Age | The Number of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) | 1 participants |
| Placebo, 18-55 Years of Age | The Number of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) | 1 participants |
| Low-dose 10 µg, 65-85 Years of Age | The Number of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) | 1 participants |
| High-dose 30 µg, 65-85 Years of Age | The Number of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) | 0 participants |
| Placebo, 65-85 Years of Age | The Number of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) | 0 participants |