| Primary | Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection | Incidence of SARS-CoV-2 infection diagnosed by study PCR among baseline negative participants, with exposure starting from first study PCR and censored at last PCR/outside vaccination and exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval. | Baseline negative with outside vaccination censored incidence rate follow-up | Posted | | Number | 95% Confidence Interval | events per 100 person years | | Measured through Month 4 study visit | person-years | person-years | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
| | Units | Counts |
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| Participants | | | person-years | |
| | Title | Denominators | Categories |
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| | | Title | Measurements |
|---|
| - OG00012.2(6.1 to 21.9)
- OG00131.8(20.3 to 47.2)
- OG00289.6(65.4 to 119.9)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring. | | | | | Vaccine efficacy, (1-HR) *100% | 52.6 | | | 2-Sided | 95 | -14.1 | 80.3 | | | "Immediate Vaccination" compared to "Standard of care" (reference). Wald 95% CI. | | Superiority | | |
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| Primary | Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load | As a measure of infection and a proxy of infectiousness, mean observed peak viral load (minimum cycle threshold) in nasal samples from FAS-P participants diagnosed with SARS-CoV-2 infection, stratified by lab and target (nucleocapsid gene N1 or N2). Nasal swabs were to be collected daily, and viral load was measured on available specimens taken between the first and last days of PCR-confirmed SARS-CoV-2 infection. Due to early termination, the study was underpowered to look at the vaccine effect on viral load and limited descriptive analysis was performed. The number participants analyzed per row is less than the overall number analyzed as participants were only analyzed by one of the two labs and in few cases the N2 target values could not be measured. | | Posted | | Mean | Full Range | Cycle Thresholds | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 |
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| Primary | Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load | As a measure of infection and a proxy of infectiousness, median observed peak viral load (minimum cycle threshold) in nasal samples from FAS-P participants diagnosed with SARS-CoV-2 infection, stratified by lab and target (nucleocapsid gene N1 or N2). Nasal swabs were to be collected daily, and viral load was measured on available specimens taken between the first and last days of PCR-confirmed SARS-CoV-2 infection. Due to early termination, the study was underpowered to look at the vaccine effect on viral load and limited descriptive analysis was performed. The number participants analyzed per row is less than the overall number analyzed as participants were only analyzed by one of the two labs and in few cases the N2 target values could not be measured. | | Posted | | Median | Inter-Quartile Range | Cycle Thresholds | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | |
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| Secondary | Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms | Incidence of study PCR-confirmed SARS-CoV-2 infection and concurrent symptoms captured by daily or weekly symptom reporting (at least one of the following: hospitalization, fever, chills, cough, shortness of breath, difficulty breathing, tiredness/fatigue, muscle aches, joint aches, body aches, headache, change in sense of taste, change in sense of smell, sore throat, nasal congestion, runny nose, nausea, vomiting, diarrhea, oral ulcers and clinical or radiographical evidence of pneumonia) among baseline negative participants. Exposure starting from first study PCR and censored at last PCR/outside vaccination. Participants without concurrent symptom data were assumed not symptomatic and were additionally censored at SARS-CoV-2 infection. Exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval. | Baseline negative with outside vaccination censored incidence rate follow-up | Posted | | Number | 95% Confidence Interval | events per 100 person years | | Measured through Month 4 study visit | person-years | person-years | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care |
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| Secondary | Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity | Incidence of SARS-CoV-2 infection diagnosed by study PCR among FAS-P participants, with exposure starting from first study PCR and censored at last PCR/outside vaccination and exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval. | FAS-P with outside vaccination censored incidence rate follow-up | Posted | | Number | 95% Confidence Interval | events per 100 person years | | Measured through Month 4 study visit | person-years | person-years | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
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| Secondary | Impact of Moderna COVID-19 Vaccine on Secondary Transmission of SARS-CoV-2 Infection | Evaluated by the number of secondary transmission events in close-contact cohorts from main study participants who were SARS-CoV-2 seronegative at enrollment | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
| |
| Secondary | Efficacy of Moderna COVID-19 Vaccine to Prevent Serologically Confirmed SARS-CoV-2 Infection | Evaluated by SARS-CoV-2 antibodies to the nucleocapsid protein post Month 1 visit among participants who were SARS-CoV-2 seronegative at enrollment | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
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| Secondary | Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms | Evaluated by SARS-CoV-2 infection confirmed by PCR among participants who were SARS-CoV-2 seronegative at enrollment; reporting at least 2 of the following systemic symptoms: Fever (≥ 38ºC), chills, myalgia, headache, sore throat; or reporting at least one of the following signs/symptoms: cough, shortness of breath or difficulty breathing, new olfactory or taste disorder, clinical or radiographical evidence of pneumonia, thromboembolic event, myocardial infarction, myocarditis, chilblains, or multi-inflammatory syndrome | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
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| Secondary | Effect of Moderna COVID-19 Vaccine on Magnitude of Viral Load Over Time | Summary measures of the viral load curve, all evaluated among participants diagnosed with SARS-CoV-2 infection who were SARS-CoV-2 seronegative at enrollment | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
| |
| Secondary | Efficacy of Moderna Vaccine Regardless of Baseline Serostatus (SARS-CoV-2 Infection by PCR) | Evaluated by SARS-CoV-2 infection diagnosed by PCR | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
| |
| Secondary | Effect of Moderna Vaccine on Viral Load Regardless of Baseline Serostatus (Viral Load) | Evaluated by peak viral load in nasal samples from diagnosed participants | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
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| Secondary | Effect of Moderna Vaccine on Secondary Status Regardless of Baseline Serostatus (Secondary Transmission Events) | Evaluated by number of secondary transmission events in close-contact cohorts | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
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| Secondary | Immunogenicity of Moderna COVID-19 Vaccine | Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 2 | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
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| Secondary | Immune Responses as Correlates of Risk of SARS-CoV-2 Acquisition, Viral Load, Secondary Infection, and COVID-19 Disease | Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 2 | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
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| Secondary | Efficacy of Moderna COVID-19 Vaccine Against Asymptomatic SARS-CoV-2 Infection | SARS-CoV-2 infection by PCR or periodic serology | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
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| Secondary | Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection and COVID-19 Disease | SARS-CoV-2 infection diagnosed by PCR among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
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| Secondary | Effect of Moderna COVID-19 Vaccine on Viral Load | Measure of peak viral load among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
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| Secondary | Effect of Moderna COVID-19 Vaccine on Secondary Transmission | Measure of secondary transmission events among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits | Data have not been collected and outcome cannot be reported. | Posted | | | | | | Measured through Month 4 study visit | | | | ID | Title | Description |
|---|
| OG000 | Immediate Vaccination | Immediate Vaccination Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29. | | OG001 | Standard of Care | Standard of Care Group: Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141. | | OG002 | Vaccine Declined | Vaccine Declined: Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study |
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