SARS-CoV-2, COVID-19
Conditions
Keywords
COVID-19, Pandemic, Booster vaccine
Brief summary
The purpose of Part A of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccines to control vaccine. The purpose of Part B of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccine under three different storage conditions.
Detailed description
Part A: This Phase 2 study's Part A evaluates the safety, reactogenicity, and immunogenicity of two candidate vaccines - the bivalent CV0701 and the monovalent CV0601 - in healthy adults who have received a full primary vaccination series (with or without booster doses). By including these candidates, the study will assess whether immune interference occurs between the XY spike protein and the XX spike protein antigens in the bivalent vaccine compared with the XX spike protein antigen in the monovalent vaccine. In Part A, both CV0701 and CV0601 will be compared to the Control Vaccine (that serve as a standard of care control) using a randomized, observer-blinded design. Part B: The purpose of Part B is to evaluate the safety and Day 29 immunogenicity of CV0801 under three storage conditions: * Condition 1: Baseline/control * Condition 2: Intermediate storage * Condition 3: Maximum storage Condition 1 serves as the control against which the performance (safety, reactogenicity, and immunogenicity) of Conditions 2 and 3 will be compared. mRNA vaccine stability is affected by product-specific factors (e.g., molecular weight, buffer composition, lipid nanoparticle encapsulation), manufacturing factors (such as the duration the vaccine remains in liquid form during production and handling at different temperatures), and storage conditions. The impact of these factors is based on product and process knowledge as well as clinical experience. Through Part B of this Phase 2 study, GSK and CureVac aim to develop data on how different storage conditions affect the final attributes of the vaccine in a clinical trial setting.
Interventions
BIOLOGICALCV0701 mRNA COVID-19 Vaccine (Low dose)
Study vaccine was administered as a single intramuscular injection.
BIOLOGICALCV0701 mRNA COVID-19 Vaccine (Medium dose)
Study vaccine was administered as a single intramuscular injection.
BIOLOGICALCV0701 mRNA COVID-19 Vaccine (High dose)
Study vaccine was administered as a single intramuscular injection.
BIOLOGICALCV0601 mRNA COVID-19 Vaccine
Study vaccine was administered as a single intramuscular injection.
BIOLOGICALControl vaccine
Study vaccine was administered as a single intramuscular injection.
BIOLOGICALCV0801 mRNA COVID-19 Vaccine
Study vaccine was administered as a single intramuscular injection.
Sponsors
CureVac
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
This is an observer-blind study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply: 1. Is at least 18 years old and has achieved legal age according to local regulations in each participating country. 2. Must provide documented informed consent prior to any study procedures being performed. 3. Can and will comply with the requirements of the protocol, in the opinion of the investigator. 4. Is healthy or medically stable as determined by the investigator's judgment based on medical history, vital sign measurements, and physical examination findings. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. 5. Prior receipt of an mRNA COVID-19 vaccine. This may be from a completed primary vaccination series or booster dose(s) of an approved or authorized mRNA COVID-19 vaccine. The last vaccination must be an mRNA COVID-19 vaccination received at least 3 months prior to randomization. 6. If the participant is a woman of childbearing potential, the participant may be enrolled in the study, if they: * have practiced adequate contraception for 30 days prior to study intervention administration; and * have a negative pregnancy test result on the day of study intervention administration; and * have agreed to continue adequate contraception for 2 months after study intervention administration. Female participants of non-childbearing potential may be enrolled in the study. Nonchildbearing potential is defined as current salpingectomy, hysterectomy, ovariectomy, or postmenopausal. Participants are excluded from the study if any of the following criteria apply: 1. Is pregnant or has a positive pregnancy test result at Visit 1. 2. Is breastfeeding or will (re)start breastfeeding from the study intervention administration to 3 months after study intervention administration. 3. Has any medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the participant at an unacceptable risk of injury, would render them unable to meet the requirements of the protocol or may interfere with successful completion of the study. 4. Has any history of an immunosuppressive or immunodeficient condition resulting from disease. 5. Has used immunosuppressants or other immune-modifying drugs for 14 consecutive days or more within 3 months prior to the study intervention administration. Non-systemic corticosteroids are allowed. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. 6. Has an acute medical illness or acute febrile illness with oral temperature ≥38.0°C or ≥100.4°F within 72 hours prior to study intervention administration. 7. Has participated in another study involving any investigational product, vaccine, or device within 28 days before the study intervention administration and/or planned participation through end of study (EoS). 8. Has participated in Part A of this study. 9. Has a history of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticaria, angioedema, and other significant reactions to any previous mRNA vaccine or any component of the study intervention(s). 10. Has received or plans to receive immunoglobulins or any blood or blood products within 3 months before study intervention administration through EoS. 11. Has a bleeding disorder, or prior history of significant bleeding or bruising following intramuscular injections. 12. Has a history of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. 13. Has a history of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection. 14. Has received a live vaccine 30 days before the study intervention administration or has a planned administration within 30 days after the study intervention administration. 15. Has received a non-replicating vaccine 8 days before the study intervention administration or has a planned administration within 14 days after the study intervention administration. 16. Has a documented history of confirmed SARS-CoV-2 infection within 3 months before study intervention administration. 17. Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection within 2 weeks before study intervention administration. 18. Is an employee or family member of the investigator or study site staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs | Day 1 to Day 181 | — |
| Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | At Day 29 | — |
| Part B: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | At Day 29 | — |
| Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Day 1 to Day 7 | Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade. |
| Part A: Number of Participants Reporting Any Solicited Systemic AEs | Day 1 to Day 7 | Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature is higher than or equal to (\>=) 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade. |
| Part A: Number of Participants Reporting Any Unsolicited AEs | Day 1 to Day 28 | An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade. |
| Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | Day 1 to Day 181 | An SAE refers to any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or extends existing hospitalization, causes persistent or significant disability/incapacity, involves a congenital anomaly/birth defect in a participant's offspring, includes an abnormal pregnancy outcome, or occurs in any other situation per the investigator's judgement. An MAAE results in a visit to a medical professional, such as televisits, physician's office visits, urgent care visits, emergency rooms visits, or hospitalizations. AESIs are severe or non-severe predefined AEs of scientific and medical concern specific to the product/program. This study noted the following AESIs: potential immune-mediated disease (pIMDs), lab-confirmed moderate to severe COVID-19, myocarditis and pericarditis, anaphylaxis, or severe hypersensitivity within 24 hours post-intervention. Any indicates the occurrence of the event regardless of its intensity grade. |
| Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Day 1 to Day 7 | Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade. |
| Part B: Number of Participants Reporting Any Solicited Systemic AEs | Day 1 to Day 7 | Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature \>= 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade. |
| Part B: Number of Participants Reporting Any Unsolicited AEs | Day 1 to Day 28 | An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade. |
| Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | At Day 29 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | At Day 91 and Day 181 | — |
| Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | At Day 29, Day 91 and Day 181 | — |
| Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | At Day 29 compared to baseline (Day 1) | Seroresponse is defined as post-booster titer greater than or equal to (≥) 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ. |
| Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | At Day 29 compared to baseline (Day 1) | Seroresponse is defined as post-booster titer ≥ 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ. |
| Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | At Day 29 compared to baseline (Day 1) | Seroresponse is defined as post-booster titer ≥ 4 times the LLOQ when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ. |
| Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | At Day 29, Day 91 and Day 181 compared to baseline (Day 1) | GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer. |
| Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | At Day 29, Day 91 and Day 181 compared to baseline (Day 1) | GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer. |
| Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | At Day 29, Day 91 and Day 181 compared to baseline (Day 1) | GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer. |
| Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | At Day 91 and Day 181 | — |
Countries
Australia, United States
Participant flow
Pre-assignment details
A total of 692 participants were included in enrolled set out of which only 686 were included in exposed set and started the study.
Participants by arm
| Arm | Count |
|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1. | 87 |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1. | 84 |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1. | 84 |
| Part A: CV0601 mRNA COVID-19 Vaccine Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1. | 85 |
| Part A: Control Vaccine Participants received one dose of the control vaccine at Day 1. | 85 |
| Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition) Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition. | 86 |
| Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition) Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition. | 87 |
| Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition) Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition. | 88 |
| Total | 686 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Early Withdrawal: Participant relocated and cannot attend the site | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 | 1 | 2 | 1 | 1 | 2 | 3 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Control Vaccine | Total | Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition) | Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition) | Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition) |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Part A | 53.3 Years STANDARD_DEVIATION 16.94 | 52.5 Years STANDARD_DEVIATION 16.61 | 54.1 Years STANDARD_DEVIATION 16.71 | 53.9 Years STANDARD_DEVIATION 15.53 | 54.2 Years STANDARD_DEVIATION 16.66 | 53.6 Years STANDARD_DEVIATION 16.53 | — | — | — |
| Age, Continuous Part B | — | — | — | — | — | 53.6 Years STANDARD_DEVIATION 17.26 | 53.4 Years STANDARD_DEVIATION 17.94 | 53.2 Years STANDARD_DEVIATION 17.25 | 54.3 Years STANDARD_DEVIATION 16.76 |
| Race/Ethnicity, Customized Aboriginal Australian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants | 8 Participants | 6 Participants | 7 Participants | 9 Participants | 64 Participants | 8 Participants | 11 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Japanese Origin | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 7 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other, Unspecified | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 76 Participants | 73 Participants | 77 Participants | 73 Participants | 73 Participants | 593 Participants | 73 Participants | 72 Participants | 76 Participants |
| Sex: Female, Male Female | 41 Participants | 37 Participants | 45 Participants | 45 Participants | 38 Participants | 334 Participants | 42 Participants | 39 Participants | 47 Participants |
| Sex: Female, Male Male | 43 Participants | 47 Participants | 42 Participants | 40 Participants | 47 Participants | 352 Participants | 44 Participants | 48 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 84 | 0 / 84 | 0 / 85 | 0 / 85 | 0 / 86 | 0 / 87 | 0 / 88 |
| other Total, other adverse events | 64 / 87 | 68 / 84 | 72 / 84 | 62 / 85 | 75 / 85 | 62 / 86 | 55 / 87 | 65 / 88 |
| serious Total, serious adverse events | 3 / 87 | 0 / 84 | 3 / 84 | 1 / 85 | 3 / 85 | 2 / 86 | 2 / 87 | 4 / 88 |
Outcome results
Primary
Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Time frame: At Day 29
Population: Analysis was performed on the Per Protocol Set (PPS) which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XX spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | 1266.7 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | 1786.9 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | 2122.1 Titers |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | 2218.6 Titers |
| Part A: Control Vaccine | Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | 1725.5 Titers |
Primary
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Time frame: At Day 29
Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 3725.0 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 4680.6 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 5275.7 Titers |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 5261.2 Titers |
| Part A: Control Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 4863.4 Titers |
Primary
Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
An SAE refers to any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or extends existing hospitalization, causes persistent or significant disability/incapacity, involves a congenital anomaly/birth defect in a participant's offspring, includes an abnormal pregnancy outcome, or occurs in any other situation per the investigator's judgement. An MAAE results in a visit to a medical professional, such as televisits, physician's office visits, urgent care visits, emergency rooms visits, or hospitalizations. AESIs are severe or non-severe predefined AEs of scientific and medical concern specific to the product/program. This study noted the following AESIs: potential immune-mediated disease (pIMDs), lab-confirmed moderate to severe COVID-19, myocarditis and pericarditis, anaphylaxis, or severe hypersensitivity within 24 hours post-intervention. Any indicates the occurrence of the event regardless of its intensity grade.
Time frame: Day 1 to Day 181
Population: Analysis was performed on the ES which includes all participants who received the study intervention and had post-vaccination data available for the specified duration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | MAAEs | 29 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | AESIs | 7 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | SAEs | 3 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | SAEs | 0 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | MAAEs | 21 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | AESIs | 2 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | SAEs | 3 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | MAAEs | 25 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | AESIs | 4 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | MAAEs | 31 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | AESIs | 1 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | SAEs | 1 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | SAEs | 3 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | MAAEs | 30 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | AESIs | 5 Participants |
Primary
Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Time frame: Day 1 to Day 7
Population: Analysis was performed on the eDiary Set which includes all participants in the safety analysis set for whom eDiary data are available post-vaccination for the specified duration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Swelling | 0 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Redness | 2 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Pain | 34 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Lymphadenopathy | 7 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Swelling | 1 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Pain | 46 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Lymphadenopathy | 10 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Redness | 3 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Pain | 53 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Swelling | 3 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Lymphadenopathy | 15 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Redness | 2 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Lymphadenopathy | 12 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Redness | 1 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Swelling | 1 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Pain | 40 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Lymphadenopathy | 10 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Pain | 54 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Redness | 2 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) | Swelling | 1 Participants |
Primary
Part A: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature is higher than or equal to (\>=) 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Time frame: Day 1 to Day 7
Population: Analysis was performed on the eDiary Set which includes all participants in the safety analysis set for whom eDiary data are available post-vaccination for the specified duration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Chills | 5 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Fatigue | 30 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Myalgia | 14 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Arthralgia | 9 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Headache | 20 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Fever | 0 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Arthralgia | 7 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Headache | 30 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Fever | 1 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Myalgia | 20 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Chills | 9 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Fatigue | 26 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Arthralgia | 13 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Chills | 11 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Fever | 2 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Fatigue | 40 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Headache | 37 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Myalgia | 35 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Chills | 3 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Fatigue | 24 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Fever | 2 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Headache | 27 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Myalgia | 25 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Arthralgia | 4 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Chills | 9 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Fatigue | 34 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Arthralgia | 14 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Fever | 3 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Headache | 28 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Solicited Systemic AEs | Myalgia | 28 Participants |
Primary
Part A: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
Time frame: Day 1 to Day 28
Population: Analysis was performed on the Exposed Set (ES) which includes all participants who received the study intervention and had unsolicited AEs data available post-vaccination for the specified duration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Number of Participants Reporting Any Unsolicited AEs | 20 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Number of Participants Reporting Any Unsolicited AEs | 22 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Number of Participants Reporting Any Unsolicited AEs | 21 Participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Number of Participants Reporting Any Unsolicited AEs | 27 Participants |
| Part A: Control Vaccine | Part A: Number of Participants Reporting Any Unsolicited AEs | 23 Participants |
Primary
Part B: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Time frame: At Day 29
Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 5658.8 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 4889.4 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 4629.7 Titers |
Primary
Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs
Time frame: Day 1 to Day 181
Population: Analysis was performed on the ES which includes all participants who received the study intervention and had post-vaccination data available for the specified duration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs | SAEs | 2 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs | MAAEs | 24 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs | AESIs | 0 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs | SAEs | 2 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs | MAAEs | 26 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs | AESIs | 2 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs | MAAEs | 23 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs | AESIs | 2 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs | SAEs | 4 Participants |
Primary
Part B: Number of Participants Reporting Any Solicited Administration Site AEs
Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Time frame: Day 1 to Day 7
Population: Analysis was performed on the eDiary Set which includes all participants in the safety analysis set for whom eDiary data are available post-vaccination for the specified duration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Pain | 34 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Swelling | 3 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Redness | 1 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Lymphadenopathy | 6 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Lymphadenopathy | 5 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Pain | 42 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Redness | 0 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Swelling | 2 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Lymphadenopathy | 10 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Swelling | 1 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Redness | 3 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any Solicited Administration Site AEs | Pain | 42 Participants |
Primary
Part B: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature \>= 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Time frame: Day 1 to Day 7
Population: Analysis was performed on the eDiary Set which includes all participants in the safety analysis set for whom eDiary data are available post-vaccination for the specified duration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Fever | 0 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Myalgia | 11 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Chills | 1 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Fatigue | 28 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Headache | 19 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Arthralgia | 6 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Arthralgia | 9 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Fever | 0 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Fatigue | 28 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Headache | 15 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Myalgia | 21 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Chills | 2 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Myalgia | 19 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Chills | 1 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Arthralgia | 9 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Fatigue | 28 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Fever | 0 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any Solicited Systemic AEs | Headache | 28 Participants |
Primary
Part B: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
Time frame: Day 1 to Day 28
Population: Analysis was performed on the ES which includes all participants who received the study intervention and had unsolicited AEs data available post-vaccination for the specified duration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part B: Number of Participants Reporting Any Unsolicited AEs | 17 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part B: Number of Participants Reporting Any Unsolicited AEs | 18 Participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part B: Number of Participants Reporting Any Unsolicited AEs | 18 Participants |
Secondary
Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Time frame: At Day 29, Day 91 and Day 181 compared to baseline (Day 1)
Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XX spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 29 | 2.72 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 181 | 0.96 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 91 | 1.69 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 91 | 2.29 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 29 | 3.84 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 181 | 1.31 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 91 | 2.86 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 29 | 4.56 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 181 | 1.61 Ratio |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 29 | 4.77 Ratio |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 181 | 1.70 Ratio |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 91 | 2.95 Ratio |
| Part A: Control Vaccine | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 91 | 2.23 Ratio |
| Part A: Control Vaccine | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 29 | 3.71 Ratio |
| Part A: Control Vaccine | Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 181 | 1.21 Ratio |
Secondary
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Time frame: At Day 29, Day 91 and Day 181 compared to baseline (Day 1)
Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 29 | 2.14 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 181 | 1.07 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 91 | 1.41 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 91 | 1.98 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 29 | 2.68 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 181 | 1.42 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 91 | 2.28 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 29 | 3.03 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 181 | 1.61 Ratio |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 29 | 3.02 Ratio |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 181 | 1.57 Ratio |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 91 | 2.11 Ratio |
| Part A: Control Vaccine | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 91 | 1.72 Ratio |
| Part A: Control Vaccine | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 29 | 2.79 Ratio |
| Part A: Control Vaccine | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 181 | 1.28 Ratio |
Secondary
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Time frame: At Day 29, Day 91 and Day 181 compared to baseline (Day 1)
Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XZ spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 29 | 2.66 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 181 | 1.16 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 91 | 1.78 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 91 | 2.40 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 29 | 3.82 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 181 | 1.44 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 91 | 3.30 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 29 | 4.55 Ratio |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 181 | 1.87 Ratio |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 29 | 5.49 Ratio |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 181 | 1.98 Ratio |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 91 | 3.30 Ratio |
| Part A: Control Vaccine | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 91 | 2.47 Ratio |
| Part A: Control Vaccine | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 29 | 3.61 Ratio |
| Part A: Control Vaccine | Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 181 | 1.29 Ratio |
Secondary
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Time frame: At Day 91 and Day 181
Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XX spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 91 | 872.5 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 181 | 585.0 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 91 | 1181.9 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 181 | 797.0 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 91 | 1477.7 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 181 | 977.6 Titers |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 181 | 1032.6 Titers |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 91 | 1527.8 Titers |
| Part A: Control Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 91 | 1155.6 Titers |
| Part A: Control Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | Day 181 | 734.2 Titers |
Secondary
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Time frame: At Day 91 and Day 181
Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 91 | 2637.0 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 181 | 2215.8 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 91 | 3714.0 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 181 | 2935.4 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 91 | 4284.9 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 181 | 3319.3 Titers |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 181 | 3243.6 Titers |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 91 | 3952.1 Titers |
| Part A: Control Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 91 | 3216.5 Titers |
| Part A: Control Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | Day 181 | 2640.6 Titers |
Secondary
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
Time frame: At Day 29, Day 91 and Day 181
Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XZ spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 29 | 196.0 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 181 | 105.3 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 91 | 139.8 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 91 | 188.6 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 29 | 281.5 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 181 | 131.1 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 91 | 259.6 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 29 | 335.0 Titers |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 181 | 170.2 Titers |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 29 | 404.3 Titers |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 181 | 180.2 Titers |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 91 | 259.5 Titers |
| Part A: Control Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 91 | 194.5 Titers |
| Part A: Control Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 29 | 265.7 Titers |
| Part A: Control Vaccine | Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | Day 181 | 117.2 Titers |
Secondary
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Seroresponse is defined as post-booster titer greater than or equal to (≥) 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
Time frame: At Day 29 compared to baseline (Day 1)
Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XX spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | 38.5 Percentage of participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | 50.0 Percentage of participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | 50.7 Percentage of participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | 51.4 Percentage of participants |
| Part A: Control Vaccine | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein | 48.1 Percentage of participants |
Secondary
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Seroresponse is defined as post-booster titer ≥ 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
Time frame: At Day 29 compared to baseline (Day 1)
Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 17.9 Percentage of participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 25.7 Percentage of participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 29.3 Percentage of participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 25.7 Percentage of participants |
| Part A: Control Vaccine | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein | 35.0 Percentage of participants |
Secondary
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
Seroresponse is defined as post-booster titer ≥ 4 times the LLOQ when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
Time frame: At Day 29 compared to baseline (Day 1)
Population: Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XZ spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose) | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | 39.7 Percentage of participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose) | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | 43.8 Percentage of participants |
| Part A: CV0701 mRNA COVID-19 Vaccine (High Dose) | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | 55.4 Percentage of participants |
| Part A: CV0601 mRNA COVID-19 Vaccine | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | 47.3 Percentage of participants |
| Part A: Control Vaccine | Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein | 47.5 Percentage of participants |