Coronavirus, Covid19, SARS-CoV-2, Severe Acute Respiratory Syndrome
Conditions
Keywords
Vaccine, SARS, COVID, Safety, Reactogenicity, Immunogenicity
Brief summary
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine (CVnCoV) at different dose levels and to evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV.
Detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Interventions
BIOLOGICALCVnCoV 6 μg
Participants will receive an intramuscular injection by needle in the deltoid area.
BIOLOGICALCVnCoV 12 μg
Participants will receive an intramuscular injection by needle in the deltoid area.
BIOLOGICALHepatitis A vaccine
Participants will receive an intramuscular injection by needle in the deltoid area.
BIOLOGICALPneumococcal vaccine
Participants will receive an intramuscular injection by needle in the deltoid area.
BIOLOGICALCVnCoV 12μg
Participants will receive an intramuscular injection by needle in the deltoid area.
Sponsors
German Federal Ministry of Education and Research
CureVac
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female participants ≥18 years of age. A healthy participant is defined as an individual who is in good general health, according to the Investigator's assessment. Chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the Investigator. * Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. * Participants are able to understand and willing to provide informed consent. * Physical examination without clinically significant findings according to the Investigator's assessment. * Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2. * Female participants of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for female participants presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before). * Female participants of childbearing potential must use highly effective methods of birth control from 2 weeks before the first administration of the trial vaccine until 3 months following the last administration. The following methods of birth control are considered highly effective when used consistently and correctly: * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); * Intrauterine devices; * Intrauterine hormone-releasing systems; * Bilateral tubal occlusion; * Vasectomized partner; * Sexual abstinence (periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable). * Male participants should be instructed not to get their partners pregnant until 3 months after the last administration.
Exclusion criteria
* Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period. * Receipt of any other vaccines within 28 days prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration (primary dose or booster dose). * Receipt of any investigational or licensed/authorized SARS-CoV-2 or other coronavirus vaccine prior to the administration of the trial vaccine. * Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied, inhaled, or intranasal steroids. * Use of hormonal therapy for gender reassignment. * Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis B virus infection, and hepatitis C virus infection. * History of immune-mediated or autoimmune disease. * History of angioedema (known C1 inhibitor deficiency). * History of anaphylaxis or allergy to any component of CVnCoV or aminoglycoside antibiotics. * History of or current alcohol and/or drug abuse. * Participants who are active smokers, were active smokers within the last year (including any vaping in the last year), or have a total smoking history ≥10 pack years. A pack year is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. * History of virologically-confirmed Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or COVID-19 disease or known exposure (without any personal protective equipment) to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within the past 2 weeks. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine. * Presence or evidence of significant uncontrolled acute or chronic medical or psychiatric illness. Significant medical or psychiatric illnesses include but are not limited to: * Uncontrolled respiratory disease (e.g., chronic obstructive pulmonary disease, asthma), including use of the following asthma medications: intravenous corticosteroids, leukotriene modifiers, biologics. * Uncontrolled cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease, history of stroke, peripheral artery disease, pulmonary embolism). * History of myocarditis or pericarditis as an adult. * Diabetes mellitus (insulin-dependent). * Uncontrolled neurological disorders or Guillain-Barré syndrome or history of seizure, except for febrile seizures during childhood. * Current or past malignancy, unless completely resolved without sequelae for \>5 years. * Foreseeable non-compliance with protocol, as judged by the Investigator. * For female participants: pregnancy or lactation. * Participants with impaired coagulation or any bleeding disorder in whom an intramuscular injection or a blood draw is contraindicated. This includes participants on treatment with anticoagulants (e.g., vitamin K antagonists, novel oral anticoagulants, and heparin). Use of platelet aggregation inhibitors is not exclusionary. * Participants employed by the Sponsor, Investigator, or trial site, or relatives of research staff working on this trial. * Participants considered at the Investigator's discretion to be at increased risk of exposure to COVID-19 disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 and Day 43 | The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
| Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36) | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome. |
| Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36) | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after day 8 are included. |
| Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Up to 28 days after Dose 1 (Days 1 to 29) and Dose 2 (Days 29 to 57) | Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. |
| Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Up to 28 days after Dose 1 (Days 1 to 29) and Dose 2 (Days 29 to 57) | Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories: * Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. * Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities. * Severe: an event that prevented normal everyday activities. |
| Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Up to Day 393 | An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. |
| Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Up to Day 393 | AESIs included: * AEs with a suspected immune-medicated etiology. * COVID-19 disease. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever was earlier. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. |
| Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Baseline, Day 29 and Day 43 | As measured by enzyme-linked immunosorbent assay (ELISA). In participants not exposed to SARS-CoV-2 before the trial seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
| Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 29 and Day 43 | As measured by ELISA. The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
| Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Baseline, Day 29 and Day 43 | As measured by an activity assay. In participants not exposed to SARS-CoV-2 before the trial, seroconversion was defined as any increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine. |
| Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36) | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187) | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome. |
| Duration of Solicited AEs Occurring on the Day of Booster Vaccination and the Following 7 Days | Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187) | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the adverse event. |
| Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Booster Vaccination and the Following 28 Days | Up to 28 days after booster vaccination (Days 57 to 85 and Days 180 to 208) | Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. |
| Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days | Up to 28 days after booster vaccination (Days 57 to 85 and Days 180 to 208) | Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories: * Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. * Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities. * Severe: an event that prevented normal everyday activities. |
| Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | For participants who received the booster vaccination on Day 57: Baseline, Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Baseline, Day 180, Day 208 and Day 393 | As measured by ELISA. In participants not exposed to SARS-CoV-2 before the trial seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine. |
| GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | For participants who received the booster vaccination on Day 57: Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Day 180, Day 208 and Day 393 | As measured by ELISA. The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine. |
| Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | For participants who received the booster vaccination on Day 57: Baseline, Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Baseline, Day 180, Day 208 and Day 393 | As measured by an activity assay. In participants not exposed to SARS-CoV-2 before the trial, seroconversion was defined as any increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
| GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | For participants who received the booster vaccination on Day 57: Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Day 180, Day 208 and Day 393 | As measured by an activity assay. The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine. |
| Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days | Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187) | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE. |
Countries
Panama, Peru
Participant flow
Recruitment details
This trial was performed in Peru and Panama between 21 September 2020 and 21 February 2022.
Pre-assignment details
Of the 1035 participants who were screened, 668 participants were enrolled and received trial vaccine.
Participants by arm
| Arm | Count |
|---|---|
| CVnCoV 6 μg: Aged 18-60 Years Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old. | 12 |
| CVnCoV 6 μg: Aged >60 Years Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. | 11 |
| CVnCoV 12 μg: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old.
CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1. | 289 |
| CVnCoV 12 μg: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1. | 295 |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old. | 31 |
| Active Control - Pneumococcal Vaccine: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. | 30 |
| Total | 668 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 5 | 6 | 2 | 1 |
| Overall Study | Miscellaneous | 0 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 10 | 18 | 1 | 8 |
Baseline characteristics
| Characteristic | Total | Active Control - Pneumococcal Vaccine: Aged >60 Years | Active Control - Hepatitis A Vaccine: Aged 18-60 Years | CVnCoV 12 μg: Aged >60 Years | CVnCoV 12 μg: Aged 18-60 Years | CVnCoV 6 μg: Aged >60 Years | CVnCoV 6 μg: Aged 18-60 Years |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 18.16 | 66.7 years STANDARD_DEVIATION 5.07 | 31.6 years STANDARD_DEVIATION 12.31 | 69.0 years STANDARD_DEVIATION 6.06 | 38.1 years STANDARD_DEVIATION 12.08 | 65.6 years STANDARD_DEVIATION 4.08 | 50.2 years STANDARD_DEVIATION 8.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 654 Participants | 30 Participants | 31 Participants | 287 Participants | 283 Participants | 11 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 0 Participants | 0 Participants | 8 Participants | 6 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 649 Participants | 29 Participants | 30 Participants | 284 Participants | 283 Participants | 11 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 14 Participants | 1 Participants | 0 Participants | 10 Participants | 3 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 296 Participants | 16 Participants | 12 Participants | 139 Participants | 118 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 372 Participants | 14 Participants | 19 Participants | 156 Participants | 171 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 3 / 584 | 1 / 61 |
| other Total, other adverse events | 21 / 23 | 567 / 584 | 59 / 61 |
| serious Total, serious adverse events | 1 / 23 | 14 / 584 | 1 / 61 |
Outcome results
Primary
Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after day 8 are included.
Time frame: Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
Population: The Safety Analysis Set including only participants who experienced solicited local and systemic AEs. Only participants with evaluable samples at each visit are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | 2.1 days | Standard Deviation 1.27 |
| CVnCoV 6 μg: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | 2.1 days | Standard Deviation 2.32 |
| CVnCoV 6 μg: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | 1.3 days | Standard Deviation 0.5 |
| CVnCoV 6 μg: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | 1.5 days | Standard Deviation 1 |
| CVnCoV 6 μg: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | 1.2 days | Standard Deviation 0.45 |
| CVnCoV 6 μg: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | 2.3 days | Standard Deviation 2.43 |
| CVnCoV 6 μg: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | 1.5 days | Standard Deviation 0.84 |
| CVnCoV 6 μg: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | 2.3 days | Standard Deviation 1.15 |
| CVnCoV 12 μg: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | 1.9 days | Standard Deviation 1.13 |
| CVnCoV 12 μg: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | 2.1 days | Standard Deviation 1.12 |
| CVnCoV 12 μg: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | 1.9 days | Standard Deviation 1.25 |
| CVnCoV 12 μg: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | 2.2 days | Standard Deviation 1.11 |
| CVnCoV 12 μg: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | 2.1 days | Standard Deviation 1.49 |
| CVnCoV 12 μg: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | 1.8 days | Standard Deviation 1.54 |
| CVnCoV 12 μg: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | 1.9 days | Standard Deviation 1.33 |
| CVnCoV 12 μg: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | 2.1 days | Standard Deviation 1.42 |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | 1.9 days | Standard Deviation 0.86 |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | 1.6 days | Standard Deviation 0.87 |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | 2.2 days | Standard Deviation 1.17 |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | 2.2 days | Standard Deviation 2.45 |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | 2.3 days | Standard Deviation 2.05 |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | 2.0 days | Standard Deviation 1.2 |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | 2.2 days | Standard Deviation 0.96 |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | 2.4 days | Standard Deviation 2.17 |
Primary
Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43
As measured by ELISA. The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Day 29 and Day 43
Population: The Immunogenicity Set including only participants who received Dose 1 and Dose 2 with no protocol deviations with impact to immunogenicity, who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected and had a blood sample collected at Day 43.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 29 | 50.000 titers | Standard Deviation 1 |
| CVnCoV 6 μg: Aged 18-60 Years | Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 43 | 462.744 titers | Standard Deviation 3.4299 |
| CVnCoV 6 μg: Aged >60 Years | Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 29 | 57.154 titers | Standard Deviation 1.5264 |
| CVnCoV 6 μg: Aged >60 Years | Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 43 | 464.788 titers | Standard Deviation 4.2969 |
| CVnCoV 12 μg: Aged 18-60 Years | Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 29 | 67.221 titers | Standard Deviation 2.6624 |
| CVnCoV 12 μg: Aged 18-60 Years | Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 43 | 1733.125 titers | Standard Deviation 4.2886 |
| CVnCoV 12 μg: Aged >60 Years | Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 29 | 63.828 titers | Standard Deviation 2.6005 |
| CVnCoV 12 μg: Aged >60 Years | Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 43 | 552.782 titers | Standard Deviation 5.1208 |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 29 | 56.724 titers | Standard Deviation 1.5434 |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 43 | 57.455 titers | Standard Deviation 1.5663 |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 29 | 52.112 titers | Standard Deviation 1.2195 |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 | Day 43 | 62.667 titers | Standard Deviation 2.8146 |
Primary
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43
The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Day 29 and Day 43
Population: The Immunogenicity Set including only participants who received Dose 1 and Dose 2 with no protocol deviations with impact to immunogenicity, who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected and had a blood sample collected at Day 43.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 | 5.000 titers | Standard Deviation 1 |
| CVnCoV 6 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 43 | 16.339 titers | Standard Deviation 3.6716 |
| CVnCoV 6 μg: Aged >60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 | 5.000 titers | Standard Deviation 1 |
| CVnCoV 6 μg: Aged >60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 43 | 20.705 titers | Standard Deviation 2.8993 |
| CVnCoV 12 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 | 5.912 titers | Standard Deviation 2.0106 |
| CVnCoV 12 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 43 | 50.298 titers | Standard Deviation 4.0175 |
| CVnCoV 12 μg: Aged >60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 | 6.234 titers | Standard Deviation 2.4723 |
| CVnCoV 12 μg: Aged >60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 43 | 26.848 titers | Standard Deviation 3.9517 |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 | 5.000 titers | Standard Deviation 1 |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 43 | 5.000 titers | Standard Deviation 1 |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 | 5.000 titers | Standard Deviation 1 |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 43 | 5.000 titers | Standard Deviation 1 |
Primary
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
Time frame: Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
Population: The Safety Analysis Set including only participants who experienced solicited local and systemic AEs. Only participants with evaluable samples at each visit are included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 1 | 9 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 2 | 0 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 3 | 0 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 3 | 0 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 2 | 0 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 2 | 2 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 1 | 7 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 3 | 0 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 1 | 9 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 3 | 0 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 1 | 4 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 2 | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 2 | 1 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 1 | 2 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 2 | 2 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 3 | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 3 | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 1 | 4 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 2 | 1 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 3 | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 2 | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 1 | 5 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 3 | 2 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 1 | 5 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 3 | 8 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 1 | 191 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 2 | 61 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 3 | 1 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 1 | 122 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 2 | 96 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 3 | 11 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 1 | 166 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 2 | 42 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 3 | 0 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 1 | 100 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 2 | 109 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 1 | 122 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 2 | 17 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 1 | 203 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 2 | 83 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 2 | 25 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 2 | 65 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 3 | 6 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 1 | 162 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 3 | 0 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 3 | 9 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 3 | 1 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 1 | 103 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 1 | 7 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 3 | 0 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 1 | 16 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 2 | 1 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 3 | 0 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 2 | 6 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 1 | 7 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 2 | 6 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 3 | 0 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 2 | 1 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 1 | 5 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 3 | 0 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 3 | 0 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 1 | 11 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 1 | 17 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 3 | 0 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | Grade 2 | 5 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 3 | 0 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 2 | 1 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 1 | 8 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | Grade 1 | 25 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 3 | 0 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | Grade 2 | 3 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | Grade 2 | 3 Participants |
Primary
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories: * Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. * Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities. * Severe: an event that prevented normal everyday activities.
Time frame: Up to 28 days after Dose 1 (Days 1 to 29) and Dose 2 (Days 29 to 57)
Population: The Safety Analysis Set including only participants who experienced unsolicited AEs. Only participants with evaluable samples at each visit are included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Mild | 3 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Moderate | 2 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Severe | 0 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Mild | 4 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Moderate | 0 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Severe | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Moderate | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Mild | 1 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Severe | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Mild | 6 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Severe | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Moderate | 2 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Severe | 3 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Moderate | 20 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Mild | 54 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Severe | 5 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Mild | 94 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Moderate | 21 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Mild | 63 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Moderate | 15 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Severe | 2 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Severe | 3 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Moderate | 9 Participants |
| CVnCoV 12 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Mild | 88 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Mild | 6 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Moderate | 1 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Moderate | 1 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Severe | 0 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Mild | 9 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Severe | 0 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Mild | 1 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Severe | 0 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Moderate | 6 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Unsolicited AEs | Severe | 0 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Moderate | 1 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Unsolicited AEs | Mild | 4 Participants |
Primary
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial
AESIs included: * AEs with a suspected immune-medicated etiology. * COVID-19 disease. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever was earlier. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Time frame: Up to Day 393
Population: Safety Analysis Set: All participants who received at least 1 dose of trial vaccine and for whom any post-vaccination safety data are available. Only participants with evaluable samples at each visit are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any related AESIs | 0 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 1 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 3 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any related AESIs | 0 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any related AESIs | 0 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 36 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 23 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any related AESIs | 1 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any related AESIs | 0 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 7 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any related AESIs | 0 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial | Any AESIs | 3 Participants |
Primary
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Time frame: Up to 28 days after Dose 1 (Days 1 to 29) and Dose 2 (Days 29 to 57)
Population: Safety Analysis Set: All participants who received at least 1 dose of trial vaccine and for whom any post-vaccination safety data are available. Only participants with evaluable samples at each visit are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Any unsolicited AEs | 5 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Any related unsolicited AEs | 2 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Any unsolicited AEs | 4 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Any related unsolicited AEs | 1 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Any unsolicited AEs | 3 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Any related unsolicited AEs | 1 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Any unsolicited AEs | 6 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Any related unsolicited AEs | 2 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Any related unsolicited AEs | 13 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Any unsolicited AEs | 77 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Any related unsolicited AEs | 33 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Any unsolicited AEs | 120 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Any unsolicited AEs | 105 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Any related unsolicited AEs | 7 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Any related unsolicited AEs | 26 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Any unsolicited AEs | 75 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Any unsolicited AEs | 10 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Any related unsolicited AEs | 1 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Any related unsolicited AEs | 0 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Any unsolicited AEs | 7 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Any related unsolicited AEs | 1 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Any unsolicited AEs | 7 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 2: Any related unsolicited AEs | 2 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 | Dose 1: Any unsolicited AEs | 5 Participants |
Primary
Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial
An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Time frame: Up to Day 393
Population: Safety Analysis Set: All participants who received at least 1 dose of trial vaccine and for whom any post-vaccination safety data are available. Only participants with evaluable samples at each visit are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 0 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 1 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 8 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 6 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 0 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any SAEs | 1 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial | Any related SAEs | 0 Participants |
Primary
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Time frame: Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
Population: Safety Analysis Set: All participants who received at least 1 dose of trial vaccine and for whom any post-vaccination safety data are available. Only participants with evaluable samples at each visit are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | 9 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | 4 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any related solicited systemic AEs | 4 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | 9 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | 9 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any related solicited systemic AEs | 8 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | 6 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | 3 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any related solicited systemic AEs | 8 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | 5 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any related solicited systemic AEs | 5 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | 8 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any related solicited systemic AEs | 217 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | 217 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | 208 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any related solicited systemic AEs | 228 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | 253 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | 229 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | 188 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | 193 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any related solicited systemic AEs | 190 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any related solicited systemic AEs | 193 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | 195 Participants |
| CVnCoV 12 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | 220 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | 17 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | 13 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | 13 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any related solicited systemic AEs | 13 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | 6 Participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any related solicited systemic AEs | 13 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited local AEs | 22 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any related solicited systemic AEs | 14 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any solicited systemic AEs | 11 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 2: Any related solicited systemic AEs | 11 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited systemic AEs | 14 Participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 | Dose 1: Any solicited local AEs | 26 Participants |
Primary
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43
As measured by an activity assay. In participants not exposed to SARS-CoV-2 before the trial, seroconversion was defined as any increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Time frame: Baseline, Day 29 and Day 43
Population: The Immunogenicity Set including only participants who received Dose 1 and Dose 2 with no protocol deviations with impact to immunogenicity, who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected and had a blood sample collected at Day 43.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 | 0 percentage of participants |
| CVnCoV 6 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 43 | 66.7 percentage of participants |
| CVnCoV 6 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 | 0 percentage of participants |
| CVnCoV 6 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 43 | 70.0 percentage of participants |
| CVnCoV 12 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 | 8.3 percentage of participants |
| CVnCoV 12 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 43 | 86.4 percentage of participants |
| CVnCoV 12 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 | 7.8 percentage of participants |
| CVnCoV 12 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 43 | 77.1 percentage of participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 | 0 percentage of participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 43 | 0 percentage of participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 29 | 0 percentage of participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Day 43 | 0 percentage of participants |
Primary
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43
As measured by enzyme-linked immunosorbent assay (ELISA). In participants not exposed to SARS-CoV-2 before the trial seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: Baseline, Day 29 and Day 43
Population: The Immunogenicity Set including only participants who received Dose 1 and Dose 2 with no protocol deviations with impact to immunogenicity, who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected and had a blood sample collected at Day 43.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Day 29 | 0 percentage of participants |
| CVnCoV 6 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Day 43 | 83.3 percentage of participants |
| CVnCoV 6 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Day 29 | 10.0 percentage of participants |
| CVnCoV 6 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Day 43 | 80.0 percentage of participants |
| CVnCoV 12 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Day 29 | 11.6 percentage of participants |
| CVnCoV 12 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Day 43 | 93.9 percentage of participants |
| CVnCoV 12 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Day 29 | 7.8 percentage of participants |
| CVnCoV 12 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Day 43 | 80.9 percentage of participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Day 29 | 0 percentage of participants |
| Active Control - Hepatitis A Vaccine: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Day 43 | 0 percentage of participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Day 29 | 4.3 percentage of participants |
| Active Control - Pneumococcal Vaccine: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 | Day 43 | 4.8 percentage of participants |
Secondary
Duration of Solicited AEs Occurring on the Day of Booster Vaccination and the Following 7 Days
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the adverse event.
Time frame: Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187)
Population: The Safety Analysis Set including only participants who experienced solicited local and systemic AEs. Only participants who received a booster vaccination on Day 57 or Day 180 and had evaluable samples at each visit were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | 1.7 days | Standard Deviation 0.8 |
| CVnCoV 6 μg: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | 2.8 days | Standard Deviation 2.18 |
| CVnCoV 6 μg: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | 2.0 days | Standard Deviation 1.53 |
| CVnCoV 6 μg: Aged >60 Years | Duration of Solicited AEs Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | 2.0 days | Standard Deviation 1.71 |
| CVnCoV 12 μg: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | 1.6 days | Standard Deviation 0.79 |
| CVnCoV 12 μg: Aged 18-60 Years | Duration of Solicited AEs Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | 2.0 days | Standard Deviation 2.07 |
Secondary
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393
As measured by an activity assay. The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Time frame: For participants who received the booster vaccination on Day 57: Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Day 180, Day 208 and Day 393
Population: The Immunogenicity Set including only participants who received Dose 1, Dose 2 and a booster dose on Day 57 or Day 180 with no protocol deviations with impact to immunogenicity, who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected and had a blood sample collected at Day 43.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 85 | 74.642 titers | Standard Deviation 3.0879 |
| CVnCoV 6 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 57 | 25.937 titers | Standard Deviation 4.4384 |
| CVnCoV 6 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 180 | 16.957 titers | Standard Deviation 3.3656 |
| CVnCoV 6 μg: Aged >60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 393 | 28.280 titers | — |
| CVnCoV 6 μg: Aged >60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 180 | 7.308 titers | Standard Deviation 2.5328 |
| CVnCoV 6 μg: Aged >60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 208 | 141.724 titers | Standard Deviation 2.0232 |
| CVnCoV 12 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 208 | 54.639 titers | Standard Deviation 3.3018 |
| CVnCoV 12 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 180 | 5.867 titers | Standard Deviation 1.7802 |
Secondary
GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393
As measured by ELISA. The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Time frame: For participants who received the booster vaccination on Day 57: Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Day 180, Day 208 and Day 393
Population: The Immunogenicity Set including only participants who received Dose 1, Dose 2 and a booster dose on Day 57 or Day 180 with no protocol deviations with impact to immunogenicity, who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected and had a blood sample collected at Day 43.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 85 | 2889.963 titers | Standard Deviation 2.9473 |
| CVnCoV 6 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 57 | 516.198 titers | Standard Deviation 4.6157 |
| CVnCoV 6 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 180 | 1449.055 titers | Standard Deviation 2.1869 |
| CVnCoV 6 μg: Aged >60 Years | GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 393 | 915.460 titers | — |
| CVnCoV 6 μg: Aged >60 Years | GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 180 | 445.661 titers | Standard Deviation 3.1744 |
| CVnCoV 6 μg: Aged >60 Years | GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 208 | 10094.652 titers | Standard Deviation 2.102 |
| CVnCoV 12 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 208 | 4153.249 titers | Standard Deviation 2.245 |
| CVnCoV 12 μg: Aged 18-60 Years | GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 180 | 153.160 titers | Standard Deviation 2.8146 |
Secondary
Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.
Time frame: Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187)
Population: The Safety Analysis Set including only participants who experienced solicited local and systemic AEs. Only participants who received a booster vaccination on Day 57 or Day 180 and had evaluable samples at each visit were included.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | Grade 3 | 0 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | Grade 1 | 14 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | Grade 2 | 1 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | Grade 1 | 13 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | Grade 2 | 2 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | Grade 3 | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | Grade 2 | 5 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | Grade 3 | 1 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | Grade 1 | 11 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | Grade 3 | 1 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | Grade 2 | 12 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | Grade 1 | 18 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | Grade 1 | 9 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | Grade 2 | 2 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | Grade 3 | 0 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | Grade 3 | 0 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | Grade 2 | 3 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | Grade 1 | 6 Participants |
Secondary
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories: * Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. * Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities. * Severe: an event that prevented normal everyday activities.
Time frame: Up to 28 days after booster vaccination (Days 57 to 85 and Days 180 to 208)
Population: The Safety Analysis Set including only participants who experienced unsolicited AEs. Only participants who received a booster vaccination on Day 57 or Day 180 and had evaluable samples at each visit were included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days | Moderate | 1 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days | Mild | 6 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days | Severe | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days | Moderate | 0 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days | Mild | 5 Participants |
| CVnCoV 6 μg: Aged >60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days | Severe | 1 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days | Mild | 2 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days | Severe | 0 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days | Moderate | 0 Participants |
Secondary
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Booster Vaccination and the Following 28 Days
Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Time frame: Up to 28 days after booster vaccination (Days 57 to 85 and Days 180 to 208)
Population: Safety Analysis Set: All participants who received at least 1 dose of trial vaccine and for whom any post-vaccination safety data are available. Only participants who received a booster vaccination on Day 57 or Day 180 and had evaluable samples at each visit were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Booster Vaccination and the Following 28 Days | Any unsolicited AEs | 7 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Booster Vaccination and the Following 28 Days | Any related unsolicited AEs | 1 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Booster Vaccination and the Following 28 Days | Any unsolicited AEs | 6 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Booster Vaccination and the Following 28 Days | Any related unsolicited AEs | 4 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Booster Vaccination and the Following 28 Days | Any unsolicited AEs | 2 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Booster Vaccination and the Following 28 Days | Any related unsolicited AEs | 2 Participants |
Secondary
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Time frame: Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187)
Population: Safety Analysis Set: All participants who received at least 1 dose of trial vaccine and for whom any post-vaccination safety data are available. Only participants who received a booster vaccination on Day 57 or Day 180 and had evaluable samples at each visit were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | 15 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | 15 Participants |
| CVnCoV 6 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days | Any related solicited systemic AEs | 15 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | 24 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | 24 Participants |
| CVnCoV 6 μg: Aged >60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days | Any related solicited systemic AEs | 24 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited local AEs | 12 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days | Any related solicited systemic AEs | 8 Participants |
| CVnCoV 12 μg: Aged 18-60 Years | Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days | Any solicited systemic AEs | 8 Participants |
Secondary
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393
As measured by an activity assay. In participants not exposed to SARS-CoV-2 before the trial, seroconversion was defined as any increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Time frame: For participants who received the booster vaccination on Day 57: Baseline, Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Baseline, Day 180, Day 208 and Day 393
Population: The Immunogenicity Set including only participants who received Dose 1, Dose 2 and a booster dose on Day 57 or Day 180 with no protocol deviations with impact to immunogenicity, who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected and had a blood sample collected at Day 43.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 85 | 96.0 percentage of participants |
| CVnCoV 6 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 57 | 75.0 percentage of participants |
| CVnCoV 6 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 180 | 57.1 percentage of participants |
| CVnCoV 6 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 393 | 100 percentage of participants |
| CVnCoV 6 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 180 | 28.6 percentage of participants |
| CVnCoV 6 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 208 | 100 percentage of participants |
| CVnCoV 12 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 208 | 90.0 percentage of participants |
| CVnCoV 12 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 180 | 7.7 percentage of participants |
Secondary
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393
As measured by ELISA. In participants not exposed to SARS-CoV-2 before the trial seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.
Time frame: For participants who received the booster vaccination on Day 57: Baseline, Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Baseline, Day 180, Day 208 and Day 393
Population: The Immunogenicity Set including only participants who received Dose 1, Dose 2 and a booster dose on Day 57 or Day 180 with no protocol deviations with impact to immunogenicity, who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected and had a blood sample collected at Day 43.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CVnCoV 6 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 85 | 100 percentage of participants |
| CVnCoV 6 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 57 | 82.1 percentage of participants |
| CVnCoV 6 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 180 | 100 percentage of participants |
| CVnCoV 6 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 393 | 100 percentage of participants |
| CVnCoV 6 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 180 | 90.5 percentage of participants |
| CVnCoV 6 μg: Aged >60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 208 | 100 percentage of participants |
| CVnCoV 12 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 208 | 100 percentage of participants |
| CVnCoV 12 μg: Aged 18-60 Years | Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 | Day 180 | 69.2 percentage of participants |