SARS-CoV-2
Conditions
Keywords
mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
Brief summary
The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an optional booster dose (BD) (in Parts 1 and 2).
Detailed description
This is a Phase 2/3, 3-part, open-label, dose-escalation, age de-escalation, randomized, observer-blind, placebo-controlled, expansion study intended to infer the effectiveness of mRNA-1273 in children aged 6 months to less than 12 years. Please access http://www.kidcovestudy.com for additional information, such as Study Overview, Participation, Site Locations along with contact numbers for each location for the study.
Interventions
BIOLOGICALmRNA-1273
Sterile liquid for injection
BIOLOGICALPlacebo
0.9% sodium chloride (normal saline) injection
BIOLOGICALmRNA-1273.214
Sterile liquid for injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Parts 1 and 3 are Open-label; Part 2 Randomized and Observer-blind
Eligibility
Sex/Gender
ALL
Age
6 Months to 11 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * For participants with chronic diseases (such as, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus \[HIV\] infection), the disease should be stable, per investigator assessment. * Investigator assessment that the parent(s)/legally acceptable representatives understand and are willing and physically able to comply with protocol mandated follow-up, including all procedures, written informed consent is provided, and participants provide assent. * For children 2 years of age or older has a body mass index at or above the third percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit. * For children 6 months to \<12 months of age: born at full-term with a minimum birth weight of 2.5 kilograms (kg). * For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection (Day 29) and the third dose in Part 3 (Day 149/booster dose Day 1), and not currently breastfeeding. Key
Exclusion criteria
* Known history of SARS-CoV-2 infection within 2 weeks prior to administration of vaccine or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to administration of vaccine. * Prior administration of an investigational or approved CoV (such as, SARS-CoV-2, SARS CoV, Middle East Respiratory Syndrome CoV) vaccine. * Treatment with investigational or approved agents for prophylaxis against COVID 19 (such as, receipt of SARS-CoV-2 monoclonal antibodies) within 6 months prior to enrollment. * Known hypersensitivity to a component of the vaccine or its excipients. * A medical or psychiatric condition that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results. * History of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety. * Received any non-study vaccine within 14 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine) * Received intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to Day 1 * Participated in an interventional clinical study within 28 days prior to Day 0 or plans to donate blood products while participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | Up to 28 days post-vaccination | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. COVID-19/SARS-CoV-2 infections were considered clinical events for efficacy and not AEs. A summary of SAEs and all nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section and presented by each dose group separately. |
| Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | Up to 2 years | An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. AESIs for mRNA-1273 were identified based upon medical concepts that may be related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance. An MAAE is an AE that led to an unscheduled visit to a healthcare practitioner. This included visits to a study site for unscheduled assessments and visits to healthcare practitioners external to the study site. COVID-19/SARS-CoV-2 infections were considered clinical events for efficacy and not AEs. A summary of SAEs and all nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section and presented by each dose group separately. |
| Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301 | Day 57 P204/Day 57 P301 | Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ and values greater than upper limit of quantification (ULOQ) were replaced by ULOQ if actual values were not available. LLOQ was 18.5 arbitrary units (AU)/milliliter (mL) and ULOQ was 45118 AU/mL for ID50 titer. Per-Protocol (PP) Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 and negative serology test based on binding antibody (bAb) specific to SARS-CoV-2 nucleocapsid protein at baseline, not receiving highly active antiretroviral therapy (HAART) for participants with HIV; and had no major protocol deviations that impacted key or critical data. |
| Parts 2 and 3: GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | Day 57 P204/Day 57 P301 | Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ and values \>ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline in Part 2, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key/critical data. Since the number of participants enrolled in Part 3 was substantially smaller than the planned sample size required for immunogenicity hypothesis testing after Dose 2 of mRNA-1273 25 μg primary series and after a 3rd dose of mRNA-1273 25 μg, the hypothesis testing was not performed. |
| Parts 1 and 2: Seroresponse Rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | Day 57 P204/Day 57 P301 | Percentage of participants with seroresponse for pseudovirus neutralizing antibody ID50 are reported. Seroresponse: change from below LLOQ to equal above 4\*LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ. LLOQ=18.5 AU/mL and ULOQ=45118 AU/mL for ID50 titer. PP Immunogenicity Subset: all enrolled participants who received planned doses of study vaccine, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 at baseline, not receiving HAART; and had no major protocol deviations that impacted key/critical data. Since the number of participants enrolled in Part 3 was substantially smaller than the planned sample size required for immunogenicity hypothesis testing after Dose 2 of mRNA-1273 25 μg primary series and after a 3rd dose of mRNA-1273 25 μg, the hypothesis testing was not performed. |
| Parts 2 and 3: SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | Day 57 P204/Day 57 P301 | Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 and ULOQ AU/mL was 111433 AU/mL. PP Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline in Part 2, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key or critical data. |
| Parts 1 and 2: GM Concentration of Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years of Age) Vaccine Recipients in Study P301 | BD-Day 29 P204/Day 57 P301 | Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 vaccination in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. |
| Part 3: GM Concentration of Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 | Third Dose-Day 29 P204/Day 57 P301 | Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, not receiving HAART in participants with HIV, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. Since the number of participants enrolled in Part 3 was substantially smaller than the planned sample size required for immunogenicity hypothesis testing after Dose 2 of mRNA-1273 25 μg primary series and after a 3rd dose of mRNA-1273 25 μg, the hypothesis testing was not performed. |
| Parts 1 and 2: SRR for Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 | BD-Day 29 P204/Day 57 P301 | Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 vaccination in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. |
| Part 3: SRR for Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 | Third Dose-Day 29 P204/Day 57 P301 | Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, not receiving HAART in participants with HIV were not receiving HAART, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. |
| Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 7 days post-vaccination | Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Day 1, Day 57 (1 month after Dose 2) | GM level of SARSCOV2S2P immunoglobulin G (IgG) antibody VAC123/VAC72, as measured by ECL multiplex assay specific to SARS-CoV-2 spike protein is reported. Antibody values reported as \<LLOQ were replaced by 0.5\*LLOQ and values \>ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 23 AU/mL and ULOQ was 14000000 AU/mL for VAC72. LLOQ was 69 AU/mL and ULOQ was 14400000 AU/mL for VAC123. PP Immunogenicity Subset: all enrolled participants who received planned doses of study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 protein at baseline, not receiving HAART in participants with HIV; and had no major protocol deviations. |
| Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1 (Pre-booster), BD-Day 29 (1 month after booster dose) | GM level of SARSCOV2S2P IgG antibody VAC123/VAC72 is reported. Antibody values reported as \<LLOQ were replaced by 0.5\*LLOQ and values \>ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 23 and ULOQ was 14000000 AU/mL for VAC72. LLOQ was 69 and ULOQ was 14400000 AU/mL for VAC123. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, , not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline, had BD-Day 29 antibody assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not receive off-study COVID-19 vaccination prior to BD-Day 29 visit. |
| Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181 | Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181 | GM level of SARSCOV2S2P IgG antibody against B.1.1.529 strain is reported. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 102 and ULOQ was 1180000 AU/mL for VAC123. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, participants with HIV were not receiving HAART, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impact key or critical data, and had not receive off-study COVID-19 vaccination prior to BD-Day 29 visit. |
| Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 1 and Day 57 (1 month after Dose 2) | Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ and values greater than ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. PP Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key or critical data. |
| Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Day 1 and Day 57 (1 month after Dose 2) | Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. Data are reported per Baseline SARS-CoV-2 status: Negative and Positive. PP Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline in Part 2, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key or critical data. |
| Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Baseline (Pre-Dose 1), Day 57 (1 month after Dose 2), Day 209 (6 months after Dose 2), BD-Day 1 (Pre-booster), and BD-Day 29 (1 month after booster dose or third dose) | Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 vaccination in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. |
| Part 3: GM Concentration of Post-third Dose SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181 | Baseline (Pre-Dose 1), Day 57 (1 month after Dose 2), Third Dose-Day 1 (at least 3 months or 6 months after Dose 2), Third Dose-Day 29 (1 month after third dose), and Third Dose-Day 181 (6 months after third dose) | Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, not receiving HAART in participants with HIV, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. |
| Part 2: Number of Participants With SARS-CoV-2 Infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR) | 14 days after second injection | SARS-CoV-2 infection was defined in participants with negative SARS-CoV-2 at baseline: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1, that became positive (as measured by Roche Elecsys) postbaseline; OR positive RT-PCR postbaseline. PP Set for Efficacy included all enrolled participants who received planned doses of study drug per schedule, complied with the 2nd injection timing, had no major protocol deviations that impacted key or critical efficacy data, and had a negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline. |
| Part 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys) | 14 days after second injection | Asymptomatic SARS-CoV-2 infection was identified by absence of symptoms and infections as detected by RT-PCR or serology tests: Absence of COVID-19 symptoms AND at least 1 from following: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1 that became positive post-baseline, OR positive RT-PCR test post-baseline. PP Set for Efficacy included all enrolled participants who received planned doses of study drug per schedule, complied with the 2nd injection timing, had no major protocol deviations that impacted key or critical efficacy data, and had a negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline. |
| Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19) | 14 days after second injection | A COVID-19 case was identified as a positive post-baseline RT-PCR test result together with at least 1 of following systemic symptoms: fever (≥ 38 degrees Celsius \[°C\]/≥ 100.4 degree Fahrenheit \[°F\]) or chills, fatigue, headache, myalgia, nasal congestion or rhinorrhea, new loss of taste or smell, sore throat, abdominal pain, diarrhoea, nausea/vomiting, poor appetite/poor feeding; or at least 1 of following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing. PP Set for Efficacy included all enrolled participants who received planned doses of study drug per schedule, complied with the 2nd injection timing, had no major protocol deviations that impacted key or critical efficacy data, and had a negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Deaths Related to Study Drug | Up to 2 years | A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause. |
Countries
Canada, United States
Participant flow
Recruitment details
The study was conducted in 3 parts: Part 1 (open-label; dose-escalation and age de-escalation), Part 2 (placebo-controlled), and Part 3 (open-label; lower dose regimen).
Pre-assignment details
A comparison to the mRNA-1273-P301 (NCT04470427) study's efficacy data was performed on a sub-group of mRNA-1273-P301 (P301) study participants aged 18-25 (N=296). Study Completion and Not Completion data reported in the Participant Flow were collected by Overall Study (that is, as 1 period regardless if a booster dose was received).
Participants by arm
| Arm | Count |
|---|---|
| Part 1 (6-11 Years): mRNA-1273 50 µg Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29). | 380 |
| Part 1 (6-11 Years): mRNA-1273 100 µg Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29). | 371 |
| Part 1 (2-5 Years): mRNA-1273 25 µg Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29). | 75 |
| Part 1 (2-5 Years): mRNA-1273 50 µg Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29). | 149 |
| Part 1 (6-23 Months): mRNA-1273 25 µg Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29). | 150 |
| Part 2 (6-11 Years): Placebo Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 50 μg of mRNA-1273 after the availability of a coronavirus disease 2019 (COVID-19) vaccine under EUA. | 1,004 |
| Part 2 (6-11 Years): mRNA-1273 50 µg Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29). | 3,011 |
| Part 2 (2-5 Years): Placebo Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA. | 1,008 |
| Part 2 (2-5 Years): mRNA-1273 25 µg Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29). | 3,040 |
| Part 2 (6-23 Months): Placebo Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA. | 669 |
| Part 2 (6-23 Months): mRNA-1273 25 µg Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29). | 1,995 |
| Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1, and Day 29). | 90 |
| Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301). | 296 |
| Total | 12,238 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 24 | 15 | 6 | 4 | 21 | 55 | 237 | 52 | 221 | 43 | 142 | 18 |
| Overall Study | Missing | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 2 | 1 | 1 | 0 |
| Overall Study | Other Than Specified | 6 | 5 | 3 | 2 | 6 | 31 | 86 | 66 | 388 | 48 | 258 | 4 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 | 0 | 3 | 18 | 1 | 7 | 0 | 5 | 0 |
| Overall Study | Protocol Deviation | 0 | 0 | 0 | 1 | 1 | 2 | 2 | 2 | 2 | 1 | 0 | 0 |
| Overall Study | Received Emergency Use Authorization (EUA) Vaccine | 5 | 4 | 0 | 3 | 1 | 194 | 37 | 222 | 29 | 115 | 9 | 1 |
| Overall Study | Withdrawal by Subject | 36 | 31 | 11 | 8 | 16 | 162 | 299 | 149 | 303 | 94 | 192 | 16 |
Baseline characteristics
| Characteristic | Part 1 (6-11 Years): mRNA-1273 50 µg | Part 1 (6-11 Years): mRNA-1273 100 µg | Part 1 (2-5 Years): mRNA-1273 25 µg | Part 1 (2-5 Years): mRNA-1273 50 µg | Part 1 (6-23 Months): mRNA-1273 25 µg | Part 2 (6-11 Years): Placebo | Part 2 (6-11 Years): mRNA-1273 50 µg | Part 2 (2-5 Years): Placebo | Part 2 (2-5 Years): mRNA-1273 25 µg | Part 2 (6-23 Months): Placebo | Part 2 (6-23 Months): mRNA-1273 25 µg | Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg | Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized Age Categorical Data for Participants Enrolled in Study mRNA-1273-P204 Adults (between 18 and 64 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Age Categorical Data for Participants Enrolled in Study mRNA-1273-P204 Children (2 - 11 years) | 380 Participants | 371 Participants | 75 Participants | 149 Participants | 0 Participants | 1004 Participants | 3011 Participants | 997 Participants | 3022 Participants | 0 Participants | 6 Participants | 90 Participants | 0 Participants | 9105 Participants |
| Age, Customized Age Categorical Data for Participants Enrolled in Study mRNA-1273-P204 Infants and toddlers (28 days - 23 months) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 150 Participants | 0 Participants | 0 Participants | 11 Participants | 18 Participants | 669 Participants | 1989 Participants | 0 Participants | 0 Participants | 2837 Participants |
| Age, Customized Age Categorical Data for Participants Enrolled in Study mRNA-1273-P301 Adults (between 18 and 64 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 296 Participants | 296 Participants |
| Age, Customized Age Categorical Data for Participants Enrolled in Study mRNA-1273-P301 Children (2 - 11 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Age Categorical Data for Participants Enrolled in Study mRNA-1273-P301 Infants and toddlers (28 days - 23 months) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Ethnicity Data for Participants Enrolled in Study mRNA-1273-P204 Hispanic or Latino | 72 Participants | 69 Participants | 24 Participants | 17 Participants | 15 Participants | 183 Participants | 562 Participants | 142 Participants | 429 Participants | 94 Participants | 257 Participants | 29 Participants | 0 Participants | 1893 Participants |
| Ethnicity (NIH/OMB) Ethnicity Data for Participants Enrolled in Study mRNA-1273-P204 Not Hispanic or Latino | 304 Participants | 296 Participants | 51 Participants | 129 Participants | 133 Participants | 811 Participants | 2421 Participants | 857 Participants | 2593 Participants | 568 Participants | 1719 Participants | 58 Participants | 0 Participants | 9940 Participants |
| Ethnicity (NIH/OMB) Ethnicity Data for Participants Enrolled in Study mRNA-1273-P204 Unknown or Not Reported | 4 Participants | 6 Participants | 0 Participants | 3 Participants | 2 Participants | 10 Participants | 28 Participants | 9 Participants | 18 Participants | 7 Participants | 19 Participants | 3 Participants | 0 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Ethnicity Data for Participants Enrolled in Study mRNA-1273-P301 Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 78 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Ethnicity Data for Participants Enrolled in Study mRNA-1273-P301 Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 216 Participants | 216 Participants |
| Ethnicity (NIH/OMB) Ethnicity Data for Participants Enrolled in Study mRNA-1273-P301 Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P204 American Indian or Alaska Native | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 15 Participants | 3 Participants | 11 Participants | 0 Participants | 7 Participants | 2 Participants | 0 Participants | 44 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P204 Asian | 28 Participants | 25 Participants | 8 Participants | 3 Participants | 7 Participants | 100 Participants | 297 Participants | 51 Participants | 191 Participants | 38 Participants | 94 Participants | 2 Participants | 0 Participants | 844 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P204 Black or African American | 34 Participants | 13 Participants | 3 Participants | 7 Participants | 3 Participants | 94 Participants | 310 Participants | 38 Participants | 142 Participants | 18 Participants | 62 Participants | 37 Participants | 0 Participants | 761 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P204 Multiple | 39 Participants | 31 Participants | 3 Participants | 10 Participants | 11 Participants | 98 Participants | 330 Participants | 100 Participants | 324 Participants | 76 Participants | 215 Participants | 0 Participants | 0 Participants | 1237 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P204 Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 3 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 13 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P204 Not Reported | 9 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants | 23 Participants | 4 Participants | 13 Participants | 2 Participants | 11 Participants | 1 Participants | 0 Participants | 77 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P204 Other | 3 Participants | 10 Participants | 7 Participants | 1 Participants | 3 Participants | 22 Participants | 62 Participants | 16 Participants | 43 Participants | 7 Participants | 33 Participants | 0 Participants | 0 Participants | 207 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P204 Unknown | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 10 Participants | 0 Participants | 4 Participants | 1 Participants | 5 Participants | 0 Participants | 0 Participants | 24 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P204 White | 266 Participants | 284 Participants | 54 Participants | 128 Participants | 124 Participants | 676 Participants | 1960 Participants | 793 Participants | 2307 Participants | 527 Participants | 1568 Participants | 48 Participants | 0 Participants | 8735 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 30 Participants | 30 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 29 Participants | 29 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 Multiple | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 14 Participants | 14 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Data for Participants Enrolled in Study mRNA-1273-P301 White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 207 Participants | 207 Participants |
| Sex: Female, Male Sex Data for Participants Enrolled in Study mRNA-1273-P204 Female | 185 Participants | 199 Participants | 39 Participants | 69 Participants | 67 Participants | 516 Participants | 1456 Participants | 498 Participants | 1490 Participants | 341 Participants | 981 Participants | 34 Participants | 0 Participants | 5875 Participants |
| Sex: Female, Male Sex Data for Participants Enrolled in Study mRNA-1273-P204 Male | 195 Participants | 172 Participants | 36 Participants | 80 Participants | 83 Participants | 488 Participants | 1555 Participants | 510 Participants | 1550 Participants | 328 Participants | 1014 Participants | 56 Participants | 0 Participants | 6067 Participants |
| Sex: Female, Male Sex Data for Participants Enrolled in Study mRNA-1273-P301 Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 153 Participants | 153 Participants |
| Sex: Female, Male Sex Data for Participants Enrolled in Study mRNA-1273-P301 Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 143 Participants | 143 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 | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 380 | 0 / 371 | 0 / 69 | 0 / 155 | 0 / 150 | 0 / 995 | 0 / 3,007 | 0 / 1,007 | 0 / 3,031 | 0 / 666 | 0 / 1,994 | 0 / 90 | 0 / 701 | 0 / 640 | 0 / 444 | 0 / 70 | 0 / 2,766 | 0 / 184 | 0 / 212 | 0 / 89 | 1 / 2,771 | 0 / 28 |
| other Total, other adverse events | 145 / 380 | 134 / 371 | 30 / 69 | 78 / 155 | 111 / 150 | 100 / 995 | 573 / 3,007 | 356 / 1,007 | 1,341 / 3,031 | 317 / 666 | 1,095 / 1,994 | 9 / 90 | 64 / 701 | 58 / 640 | 62 / 444 | 4 / 70 | 468 / 2,766 | 28 / 184 | 56 / 212 | 20 / 89 | 655 / 2,771 | 4 / 28 |
| serious Total, serious adverse events | 5 / 380 | 3 / 371 | 0 / 69 | 0 / 155 | 3 / 150 | 1 / 995 | 22 / 3,007 | 3 / 1,007 | 32 / 3,031 | 7 / 666 | 45 / 1,994 | 1 / 90 | 3 / 701 | 8 / 640 | 4 / 444 | 0 / 70 | 12 / 2,766 | 0 / 184 | 1 / 212 | 1 / 89 | 23 / 2,771 | 0 / 28 |
Outcome results
Primary
Part 3: GM Concentration of Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301
Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, not receiving HAART in participants with HIV, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. Since the number of participants enrolled in Part 3 was substantially smaller than the planned sample size required for immunogenicity hypothesis testing after Dose 2 of mRNA-1273 25 μg primary series and after a 3rd dose of mRNA-1273 25 μg, the hypothesis testing was not performed.
Time frame: Third Dose-Day 29 P204/Day 57 P301
Population: PP immunogenicity subset (Third Dose Analysis). Study P301 mRNA-1273 100 μg: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 3: GM Concentration of Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 | 4616.6 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Part 3: GM Concentration of Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 | 1400.4 AU/mL |
Primary
Part 3: SRR for Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301
Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, not receiving HAART in participants with HIV were not receiving HAART, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit.
Time frame: Third Dose-Day 29 P204/Day 57 P301
Population: PP immunogenicity subset (Third Dose Analysis). Study P301 mRNA-1273 100 μg: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 3: SRR for Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 | 90.0 percentage of participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Part 3: SRR for Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 | 99.3 percentage of participants |
Primary
Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. AESIs for mRNA-1273 were identified based upon medical concepts that may be related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance. An MAAE is an AE that led to an unscheduled visit to a healthcare practitioner. This included visits to a study site for unscheduled assessments and visits to healthcare practitioners external to the study site. COVID-19/SARS-CoV-2 infections were considered clinical events for efficacy and not AEs. A summary of SAEs and all nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section and presented by each dose group separately.
Time frame: Up to 2 years
Population: Safety Set of Part 1 and Part 3 included all dosed participants and of Part 2 included all randomized participants who received any study injection. Per prespecified analysis, the data for this outcome measure was not collected for participants who received only placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 85 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 1 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 1 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 1 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 71 Participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 1 Participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 2 Participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 59 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 16 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 23 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 4 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 17 Participants |
| Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 1 Participants |
| Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 3 Participants |
| Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 0 Participants |
| Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 10 Participants |
| Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 1 Participants |
| Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 7 Participants |
| Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 2 Participants |
| Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 182 Participants |
| Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 16 Participants |
| Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 901 Participants |
| Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 1 Participants |
| Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 3 (6-11 Years): BD mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 0 Participants |
| Part 3 (6-11 Years): BD mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 1 Participants |
| Part 3 (6-11 Years): BD mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 3 (6-11 Years): BD mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 1 (6-11 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 1 (6-11 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 0 Participants |
| Part 1 (6-11 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 1 (6-11 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 3 Participants |
| Part 1 (6-11 Years): mRNA-1273 100 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 3 Participants |
| Part 1 (6-11 Years): mRNA-1273 100 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 1 (6-11 Years): mRNA-1273 100 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 2 Participants |
| Part 1 (6-11 Years): mRNA-1273 100 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 137 Participants |
| Part 1 (2-5 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 9 Participants |
| Part 1 (2-5 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 616 Participants |
| Part 1 (2-5 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 1 (2-5 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 7 Participants |
| Part 1 (2-5 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 1 (2-5 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 0 Participants |
| Part 1 (2-5 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 1 (2-5 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 16 Participants |
| Part 1 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 0 Participants |
| Part 1 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 1 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 1 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 34 Participants |
| Part 2 (6-11 Years): Placebo | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 1 Participants |
| Part 2 (6-11 Years): Placebo | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 175 Participants |
| Part 2 (6-11 Years): Placebo | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 5 Participants |
| Part 2 (6-11 Years): Placebo | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 5 Participants |
| Part 2 (6-11 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 7 Participants |
| Part 2 (6-11 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 169 Participants |
| Part 2 (6-11 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 3 Participants |
| Part 2 (6-11 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 2 (2-5 Years): Placebo | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 2 (2-5 Years): Placebo | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 32 Participants |
| Part 2 (2-5 Years): Placebo | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 0 Participants |
| Part 2 (2-5 Years): Placebo | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 2 (2-5 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 0 Participants |
| Part 2 (2-5 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 80 Participants |
| Part 2 (2-5 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 1 Participants |
| Part 2 (2-5 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 2 (6-23 Months): Placebo | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 2 (6-23 Months): Placebo | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 2 Participants |
| Part 2 (6-23 Months): Placebo | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 105 Participants |
| Part 2 (6-23 Months): Placebo | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 3 Participants |
| Part 2 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 22 Participants |
| Part 2 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 1095 Participants |
| Part 2 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 2 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 19 Participants |
| Part 3 (6-11 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 1 Participants |
| Part 3 (6-11 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 13 Participants |
| Part 3 (6-11 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 32 Participants |
| Part 3 (6-11 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 1687 Participants |
| Part 2 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 13 Participants |
| Part 2 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 1 Participants |
| Part 2 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 1237 Participants |
| Part 2 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 45 Participants |
| Part 3 (6-11 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 22 Participants |
| Part 3 (6-11 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 3 (6-11 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 1 Participants |
| Part 3 (6-11 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 0 Participants |
| Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover) | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover) | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 3 Participants |
| Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover) | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 221 Participants |
| Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover) | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 3 Participants |
| Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover) | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
| Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover) | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 1 Participants |
| Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover) | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 204 Participants |
| Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover) | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 8 Participants |
| Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover) | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | SAEs | 4 Participants |
| Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover) | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AESIs | 1 Participants |
| Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover) | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | MAAEs | 171 Participants |
| Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover) | Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study | AEs Leading to Discontinuation | 0 Participants |
Primary
Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section.
Time frame: 7 days post-vaccination
Population: Solicited Safety Set: all participants in Safety Set (Safety Set of Part 1 and Part 3 included all dosed participants and of Part 2 included all randomized participants who received any study injection) who contributed any solicited AR data, that is, had at least 1 post-baseline solicited safety assessment. Per prespecified analysis, data for this endpoint was not collected for the mRNA-1273.214 treatment groups.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 216 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 221 Participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 93 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 24 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 46 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 7 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 36 Participants |
| Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 4 Participants |
| Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 12 Participants |
| Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 358 Participants |
| Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 1726 Participants |
| Part 3 (6-11 Years): BD mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 30 Participants |
| Part 1 (6-11 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 374 Participants |
| Part 1 (6-11 Years): mRNA-1273 100 µg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 367 Participants |
| Part 1 (2-5 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 62 Participants |
| Part 1 (2-5 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 147 Participants |
| Part 1 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 141 Participants |
| Part 2 (6-11 Years): Placebo | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 823 Participants |
| Part 2 (6-11 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 2983 Participants |
| Part 2 (2-5 Years): Placebo | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 797 Participants |
| Part 2 (2-5 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 2800 Participants |
| Part 2 (6-23 Months): Placebo | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 596 Participants |
| Part 2 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 1889 Participants |
| Part 3 (6-11 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | 66 Participants |
Primary
Parts 1, 2, and 3: Number of Participants With Unsolicited AEs
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. COVID-19/SARS-CoV-2 infections were considered clinical events for efficacy and not AEs. A summary of SAEs and all nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section and presented by each dose group separately.
Time frame: Up to 28 days post-vaccination
Population: Safety Set of Part 1 and Part 3 included all dosed participants and of Part 2 included all randomized participants who received any study injection. Per prespecified analysis, data for this endpoint was not collected for the mRNA-1273.214 and placebo only treatment groups.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 38 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 20 Participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 24 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 8 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 4 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 1 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 8 Participants |
| Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 1 Participants |
| Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 5 Participants |
| Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 33 Participants |
| Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 196 Participants |
| Part 3 (6-11 Years): BD mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 106 Participants |
| Part 1 (6-11 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 92 Participants |
| Part 1 (6-11 Years): mRNA-1273 100 µg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 15 Participants |
| Part 1 (2-5 Years): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 51 Participants |
| Part 1 (2-5 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 75 Participants |
| Part 1 (6-23 Months): mRNA-1273 25 µg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 785 Participants |
| Part 2 (6-11 Years): Placebo | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 1087 Participants |
| Part 2 (6-11 Years): mRNA-1273 50 µg | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 883 Participants |
| Part 2 (2-5 Years): Placebo | Parts 1, 2, and 3: Number of Participants With Unsolicited AEs | 17 Participants |
Primary
Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301
Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ and values greater than upper limit of quantification (ULOQ) were replaced by ULOQ if actual values were not available. LLOQ was 18.5 arbitrary units (AU)/milliliter (mL) and ULOQ was 45118 AU/mL for ID50 titer. Per-Protocol (PP) Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 and negative serology test based on binding antibody (bAb) specific to SARS-CoV-2 nucleocapsid protein at baseline, not receiving highly active antiretroviral therapy (HAART) for participants with HIV; and had no major protocol deviations that impacted key or critical data.
Time frame: Day 57 P204/Day 57 P301
Population: PP immunogenicity subset. Study P301 mRNA-1273 100 μg: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. 'Overall number of participants analyzed' = participants evaluable for this endpoint. As planned, Part 1 immunogenicity assessment did not serve as formal noninferiority hypothesis testing. It was intended to guide the dose selection only.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301 | 1012.5 titer |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301 | 1845.9 titer |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301 | 1782.6 titer |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301 | 1669.1 titer |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301 | 1890.2 titer |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301 | 1618.3 titer |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301 | 1321.9 titer |
95% CI: [1.061, 1.413]
Primary
Parts 1 and 2: GM Concentration of Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years of Age) Vaccine Recipients in Study P301
Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 vaccination in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit.
Time frame: BD-Day 29 P204/Day 57 P301
Population: PP immunogenicity subset (Booster Dose Analysis). Study P301 mRNA-1273 100 μg: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. 'Overall number of participants analyzed' = Pre-booster SARS-CoV-2 negative participants evaluable for this endpoint. 'Part 1 6-23 months group' and 'Part 1 2-5 years group' combined for noninferiority hypothesis testing. 'Part 1 and Part 2 groups of 6-11 years' combined for noninferiority hypothesis testing.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Concentration of Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years of Age) Vaccine Recipients in Study P301 | 1400.4 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Concentration of Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years of Age) Vaccine Recipients in Study P301 | 5457.2 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Concentration of Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years of Age) Vaccine Recipients in Study P301 | 5575.9 AU/mL |
95% CI: [3.158, 4.808]
95% CI: [3.404, 4.657]
Primary
Parts 1 and 2: Seroresponse Rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301
Percentage of participants with seroresponse for pseudovirus neutralizing antibody ID50 are reported. Seroresponse: change from below LLOQ to equal above 4\*LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ. LLOQ=18.5 AU/mL and ULOQ=45118 AU/mL for ID50 titer. PP Immunogenicity Subset: all enrolled participants who received planned doses of study vaccine, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 at baseline, not receiving HAART; and had no major protocol deviations that impacted key/critical data. Since the number of participants enrolled in Part 3 was substantially smaller than the planned sample size required for immunogenicity hypothesis testing after Dose 2 of mRNA-1273 25 μg primary series and after a 3rd dose of mRNA-1273 25 μg, the hypothesis testing was not performed.
Time frame: Day 57 P204/Day 57 P301
Population: PP immunogenicity subset. Study P301 mRNA-1273 100 μg: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. 'Overall number of participants analyzed' = participants evaluable for this endpoint. As planned, Part 1 immunogenicity assessment did not serve as formal noninferiority hypothesis testing. It was intended to guide the dose selection only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: Seroresponse Rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 99.5 percentage of participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: Seroresponse Rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 100 percentage of participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: Seroresponse Rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 100 percentage of participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: Seroresponse Rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 100 percentage of participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Parts 1 and 2: Seroresponse Rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 100 percentage of participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1 and 2: Seroresponse Rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 99.0 percentage of participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: Seroresponse Rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 99.3 percentage of participants |
95% CI: [-2.2, 1.6]
Primary
Parts 1 and 2: SRR for Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301
Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 vaccination in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit.
Time frame: BD-Day 29 P204/Day 57 P301
Population: PP immunogenicity subset (Booster Dose Analysis). Study P301 mRNA-1273 100 μg: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. 'Overall number of participants analyzed' = Pre-booster SARS-CoV-2 negative participants evaluable for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: SRR for Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 | 99.3 percentage of participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: SRR for Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 | 100 percentage of participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: SRR for Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 | 100 percentage of participants |
95% CI: [-4.4, 2.4]
95% CI: [-2.2, 2.4]
Primary
Parts 2 and 3: GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ and values \>ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline in Part 2, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key/critical data. Since the number of participants enrolled in Part 3 was substantially smaller than the planned sample size required for immunogenicity hypothesis testing after Dose 2 of mRNA-1273 25 μg primary series and after a 3rd dose of mRNA-1273 25 μg, the hypothesis testing was not performed.
Time frame: Day 57 P204/Day 57 P301
Population: PP immunogenicity subset. Study P301 mRNA-1273 100 μg: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 2 and 3: GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 1394.1 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 2 and 3: GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 1759.8 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 2 and 3: GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 4368.6 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 2 and 3: GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 1400.4 AU/mL |
95% CI: [0.87, 1.139]
95% CI: [1.101, 1.434]
Primary
Parts 2 and 3: SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301
Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 and ULOQ AU/mL was 111433 AU/mL. PP Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline in Part 2, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key or critical data.
Time frame: Day 57 P204/Day 57 P301
Population: PP immunogenicity subset. Study P301 mRNA-1273 100 μg: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 2 and 3: SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 98.9 percentage of participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 2 and 3: SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 100 percentage of participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 2 and 3: SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 88.5 percentage of participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 2 and 3: SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 | 99.3 percentage of participants |
95% CI: [-2.5, 1.5]
95% CI: [-0.8, 2.4]
Secondary
Part 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys)
Asymptomatic SARS-CoV-2 infection was identified by absence of symptoms and infections as detected by RT-PCR or serology tests: Absence of COVID-19 symptoms AND at least 1 from following: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1 that became positive post-baseline, OR positive RT-PCR test post-baseline. PP Set for Efficacy included all enrolled participants who received planned doses of study drug per schedule, complied with the 2nd injection timing, had no major protocol deviations that impacted key or critical efficacy data, and had a negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline.
Time frame: 14 days after second injection
Population: PP set for efficacy. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys) | 10 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Part 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys) | 10 Participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Part 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys) | 55 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Part 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys) | 124 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Part 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys) | 21 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Part 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys) | 70 Participants |
95% CI: [0.151, 0.882]
95% CI: [-0.007, 0.48]
95% CI: [-0.832, 0.352]
Secondary
Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19)
A COVID-19 case was identified as a positive post-baseline RT-PCR test result together with at least 1 of following systemic symptoms: fever (≥ 38 degrees Celsius \[°C\]/≥ 100.4 degree Fahrenheit \[°F\]) or chills, fatigue, headache, myalgia, nasal congestion or rhinorrhea, new loss of taste or smell, sore throat, abdominal pain, diarrhoea, nausea/vomiting, poor appetite/poor feeding; or at least 1 of following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing. PP Set for Efficacy included all enrolled participants who received planned doses of study drug per schedule, complied with the 2nd injection timing, had no major protocol deviations that impacted key or critical efficacy data, and had a negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline.
Time frame: 14 days after second injection
Population: PP set for efficacy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19) | 4 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19) | 3 Participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19) | 125 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19) | 207 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19) | 73 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19) | 130 Participants |
95% CI: [-0.416, 0.965]
95% CI: [0.328, 0.574]
95% CI: [0.232, 0.576]
Secondary
Part 2: Number of Participants With SARS-CoV-2 Infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR)
SARS-CoV-2 infection was defined in participants with negative SARS-CoV-2 at baseline: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1, that became positive (as measured by Roche Elecsys) postbaseline; OR positive RT-PCR postbaseline. PP Set for Efficacy included all enrolled participants who received planned doses of study drug per schedule, complied with the 2nd injection timing, had no major protocol deviations that impacted key or critical efficacy data, and had a negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline.
Time frame: 14 days after second injection
Population: PP set for efficacy. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 2: Number of Participants With SARS-CoV-2 Infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR) | 14 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Part 2: Number of Participants With SARS-CoV-2 Infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR) | 13 Participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Part 2: Number of Participants With SARS-CoV-2 Infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR) | 178 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Part 2: Number of Participants With SARS-CoV-2 Infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR) | 330 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Part 2: Number of Participants With SARS-CoV-2 Infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR) | 94 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Part 2: Number of Participants With SARS-CoV-2 Infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR) | 198 Participants |
95% CI: [0.325, 0.873]
95% CI: [0.287, 0.509]
95% CI: [0.127, 0.474]
Secondary
Part 3: GM Concentration of Post-third Dose SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181
Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, not receiving HAART in participants with HIV, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit.
Time frame: Baseline (Pre-Dose 1), Day 57 (1 month after Dose 2), Third Dose-Day 1 (at least 3 months or 6 months after Dose 2), Third Dose-Day 29 (1 month after third dose), and Third Dose-Day 181 (6 months after third dose)
Population: PP immunogenicity subset (Third Dose Analysis). 'Overall number of participants analyzed' = participants evaluable for this endpoint. Number analyzed = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 3: GM Concentration of Post-third Dose SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181 | Baseline | 120.0 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 3: GM Concentration of Post-third Dose SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181 | Day 57 | 3775.0 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 3: GM Concentration of Post-third Dose SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181 | Third Dose-Day 1 | 1839.1 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 3: GM Concentration of Post-third Dose SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181 | Third Dose-Day 29 | 4616.6 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 3: GM Concentration of Post-third Dose SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181 | Third Dose-Day 181 | 1432.5 AU/mL |
Secondary
Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181
GM level of SARSCOV2S2P IgG antibody against B.1.1.529 strain is reported. Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 102 and ULOQ was 1180000 AU/mL for VAC123. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, participants with HIV were not receiving HAART, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impact key or critical data, and had not receive off-study COVID-19 vaccination prior to BD-Day 29 visit.
Time frame: Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181
Population: PP immunogenicity subset (Third Dose Analysis). 'Overall number of participants analyzed = participants evaluable for this endpoint. Number analyzed = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181 | Baseline (Pre-dose 1) | 4659.5 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181 | Day 57 | 141758.0 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181 | Third Dose-Day 1 | 48176.2 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181 | Third Dose-Day 29 | 93436.4 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181 | Third Dose-Day 181 | 40271.7 AU/mL |
Secondary
Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29
Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 vaccination in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit.
Time frame: Baseline (Pre-Dose 1), Day 57 (1 month after Dose 2), Day 209 (6 months after Dose 2), BD-Day 1 (Pre-booster), and BD-Day 29 (1 month after booster dose or third dose)
Population: PP immunogenicity subset (Booster Dose Analysis). 'Overall number of participants analyzed' = participants evaluable for this endpoint. Number analyzed = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 1 | 558.0 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 57 | 1557.1 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 29 | 6474.7 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 209 | 448.6 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Baseline | 9.0 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 209 | 544.5 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 1 | 447.2 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 29 | 5778.7 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 57 | 1275.0 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Baseline | 12.8 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 209 | 790.7 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Baseline | 7.8 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 57 | 1718.7 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 1 | 795.5 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 29 | 5805.4 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 1 | 627.9 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 57 | 1503.3 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Baseline | 9.3 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 209 | 530.3 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 29 | 6991.6 AU/mL |
Secondary
Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29
GM level of SARSCOV2S2P IgG antibody VAC123/VAC72 is reported. Antibody values reported as \<LLOQ were replaced by 0.5\*LLOQ and values \>ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 23 and ULOQ was 14000000 AU/mL for VAC72. LLOQ was 69 and ULOQ was 14400000 AU/mL for VAC123. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, , not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline, had BD-Day 29 antibody assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not receive off-study COVID-19 vaccination prior to BD-Day 29 visit.
Time frame: Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1 (Pre-booster), BD-Day 29 (1 month after booster dose)
Population: PP immunogenicity subset (Booster Dose Analysis). Overall number of participants analyzed = participants evaluable for this endpoint. Number analyzed = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 57 | 302128.3 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Baseline | 50.0 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 209 | 74516.9 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 29 | 633999.7 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 1 | 66677.7 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 209 | 66516.5 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Baseline | 37.5 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 57 | 279427.6 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 1 | 68322.4 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 29 | 675348.1 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 209 | 71427.5 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Baseline | 34.5 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 29 | 536478.9 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 1 | 50621.5 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 57 | 241874.9 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 1 | 86416.4 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 209 | 85360.1 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Baseline | 51.9 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | BD-Day 29 | 520973.0 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29 | Day 57 | 336189.6 AU/mL |
Secondary
Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57
GM level of SARSCOV2S2P immunoglobulin G (IgG) antibody VAC123/VAC72, as measured by ECL multiplex assay specific to SARS-CoV-2 spike protein is reported. Antibody values reported as \<LLOQ were replaced by 0.5\*LLOQ and values \>ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 23 AU/mL and ULOQ was 14000000 AU/mL for VAC72. LLOQ was 69 AU/mL and ULOQ was 14400000 AU/mL for VAC123. PP Immunogenicity Subset: all enrolled participants who received planned doses of study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 protein at baseline, not receiving HAART in participants with HIV; and had no major protocol deviations.
Time frame: Day 1, Day 57 (1 month after Dose 2)
Population: PP immunogenicity subset. Overall number of participants analyzed= participants evaluable for this endpoint. Number analyzed = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Baseline (Day 1) | 35.6 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Day 57 | 325784.0 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Baseline (Day 1) | 49.1 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Day 57 | 457349.2 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Baseline (Day 1) | 15.8 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Day 57 | 261952.0 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Baseline (Day 1) | 33.7 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Day 57 | 417419.8 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Baseline (Day 1) | 14.6 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Day 57 | 297561.7 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Baseline (Day 1) | 32.6 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Day 57 | 293118.9 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Day 57 | 235059.2 AU/mL |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Baseline (Day 1) | 24.5 AU/mL |
| Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Baseline (Day 1) | 22.0 AU/mL |
| Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg | Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 | Day 57 | 293955.4 AU/mL |
Secondary
Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57
Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ and values greater than ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. PP Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key or critical data.
Time frame: Day 1 and Day 57 (1 month after Dose 2)
Population: PP immunogenicity subset. 'Overall number of participants analyzed' = participants evaluable for this endpoint. Number analyzed = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 1 | 9.3 titer |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 57 | 1669.1 titer |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 1 | 9.6 titer |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 57 | 1890.2 titer |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 1 | 9.3 titer |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 57 | 1012.5 titer |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 1 | 9.3 titer |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 57 | 1845.9 titer |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 1 | 9.6 titer |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 57 | 1782.6 titer |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 1 | 9.3 titer |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 | Day 57 | 1618.3 titer |
Secondary
Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57
Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. Data are reported per Baseline SARS-CoV-2 status: Negative and Positive. PP Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline in Part 2, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key or critical data.
Time frame: Day 1 and Day 57 (1 month after Dose 2)
Population: PP immunogenicity subset. 'Overall number of participants analyzed' = participants evaluable for this endpoint. Number analyzed = participants evaluable at specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Baseline SARS-CoV-2 (Negative): Day 1 | 7.9 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Baseline SARS-CoV-2(Negative): Day 57 | 1398.1 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Baseline SARS-CoV-2 (Positive): Day 57 | 7430.0 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Baseline SARS-CoV-2 (Positive): Day 1 | 175.3 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Baseline SARS-CoV-2 (Negative): Day 1 | 8.0 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Baseline SARS-CoV-2 (Positive): Day 1 | 199.9 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Baseline SARS-CoV-2(Negative): Day 57 | 1760.8 AU/mL |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Baseline SARS-CoV-2 (Positive): Day 57 | 10411.6 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Baseline SARS-CoV-2(Negative): Day 57 | 2140.6 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Baseline SARS-CoV-2 (Negative): Day 1 | 21.5 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Baseline SARS-CoV-2 (Positive): Day 1 | 177.5 AU/mL |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 | Baseline SARS-CoV-2 (Positive): Day 57 | 4592.9 AU/mL |
Other Pre-specified
Number of Deaths Related to Study Drug
A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.
Time frame: Up to 2 years
Population: Safety Set of Part 1 and Part 3 included all dosed participants and of Part 2 included all randomized participants who received any study injection. Data are reported by study part and by age categories of 6-11 years and 6 months-5 years.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 3 (6-11 Years): BD mRNA-1273 25 µg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 3 (6-11 Years): BD mRNA-1273 25 µg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 1 (6-11 Years): mRNA-1273 50 µg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 1 (6-11 Years): mRNA-1273 50 µg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 1 (6-11 Years): mRNA-1273 100 µg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 1 (6-11 Years): mRNA-1273 100 µg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 1 (2-5 Years): mRNA-1273 25 µg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 1 (2-5 Years): mRNA-1273 25 µg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 1 (2-5 Years): mRNA-1273 50 µg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 1 (2-5 Years): mRNA-1273 50 µg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 1 (6-23 Months): mRNA-1273 25 µg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 1 (6-23 Months): mRNA-1273 25 µg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 2 (6-11 Years): Placebo | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 2 (6-11 Years): Placebo | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 2 (6-11 Years): mRNA-1273 50 µg | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 2 (6-11 Years): mRNA-1273 50 µg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 2 (2-5 Years): Placebo | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 2 (2-5 Years): Placebo | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 2 (2-5 Years): mRNA-1273 25 µg | Number of Deaths Related to Study Drug | Deaths | 1 Participants |
| Part 2 (2-5 Years): mRNA-1273 25 µg | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |
| Part 2 (6-23 Months): Placebo | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Part 2 (6-23 Months): Placebo | Number of Deaths Related to Study Drug | Deaths related to study drug | 0 Participants |