Immunogenicity and Safety of the First-in-Human SARS-CoV-2 mRNA Vaccine Formulation in Healthy Adults 18 Years of Age and Older

Number of Participants With Solicited Injection Site Reactions

时间窗: Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

Solicited reaction (SR): expected adverse reaction (sign or symptom) observed \& reported under conditions (nature \& onset) prelisted (i.e., solicited) in CRF and considered as related to product administered. Solicited injection site reactions included pain, erythema, \& swelling. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.

Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36

时间窗: Day 36 (post-vaccination)

GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.

Number of Participants With Unsolicited Adverse Events

时间窗: Within 21 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.

Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)

时间窗: From Day 1 until 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups)

SAEs: 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 or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs: event for which ongoing monitoring \& rapid communication by investigator to the sponsor was done. MAAE was a new onset or worsening of a condition that prompted participant or participant's parent/legally acceptable representative to seek unplanned medical advice at physician's office or emergency department. Reported AEs for each arm were presented as pre-specified in study protocol.

Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22

时间窗: Day 1 (pre-vaccination) and Day 22 (post-vaccination)

SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.

Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)

时间窗: Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

AE: any untoward medical occurrence in clinical investigation participant administered medicinal product \& which did not have any causal relationship with the treatment. Unsolicited AE: observed AE that did not fulfill conditions prelisted in case report form (CRF) in terms of diagnosis \&/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, \& any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in CRF. Reported AEs were presented as pre-specified in protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.

Number of Participants With Solicited Systemic Reactions

时间窗: Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

SR was an expected adverse reaction (sign or symptom) observed \& reported under conditions (nature \& onset) prelisted (i.e., solicited) in CRF \& considered as related to product administered. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia \& chills. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.

Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance

时间窗: From Day 1 up to up to 8 days post last vaccination (i.e., up to Day 9 for Cohort 1 groups; up to Day 30 for Cohort 2 groups)

Laboratory tests: hemoglobin (male \& female), above \& below normal white blood cell, lymphocytes, neutrophils \& eosinophils, platelet count, creatinine \& blood urea nitrogen, hyponatremia \& hypernatremia, hyperkalemia \& hypokalemia, hyperglycemia (non-fasting), hypoproteinemia, alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, bilirubin (with any increase in liver function test \[LFT\], bilirubin (normal LFT), prothrombin \& partial thromboplastin time (seconds), Urine: protein, glucose \& blood. US FDA "Toxicity Grading Scale for Healthy Adults \& Adolescent Volunteers" was used for grading; Grade 1=mild, Grade 2=moderate \& Grade 3=severe. In the data table, 'number analyzed'=participants with available data for each specified category \& '0'=none of participants were available for assessment for specified Group.

Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1

时间窗: Day 1 (pre-vaccination)

GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22

时间窗: Day 22 (post-vaccination)

GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.

Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36

时间窗: Day 1 (pre-vaccination) and Day 36 (post-vaccination)

SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.

Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22

时间窗: Day 1 (pre-vaccination) and Day 22 (post-vaccination)

SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.

Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36

时间窗: Day 1 (pre-vaccination) and Day 36 (post-vaccination)

SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.

Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22

时间窗: Day 22 (post-vaccination)

Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 22). LLOQ of the neutralization assay was a titer of 10.

Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36

时间窗: Day 36 (post-vaccination)

Seroconversion was defined as participants with a Baseline (Day 1) titer values below LLOQ with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 36). LLOQ of the neutralization assay was a titer of 10.