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COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)

Phase 2 Clinical Trial to Optimize Immune Coverage of SARS-CoV-2 Existing and Emerging Variants

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05289037
Enrollment
1270
Registered
2022-03-21
Start date
2022-03-30
Completion date
2023-11-27
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Adaptive, COVAIL, Covid-19, Multivalent, Omicron, SARS-CoV-2, Vaccine, Variants

Brief summary

This phase 2 clinical trial will evaluate the safety and immunogenicity of additional doses of prototype and variant (alone or in combination) vaccine candidates in previously vaccinated participants with or without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and will evaluate innate, cellular, and humoral immune responses to inform on how to shift the immune response to cover new variants as they emerge. A randomized open-label, non-placebo controlled, multi-site, multi-stage clinical trial in individuals, 18 years of age and older, who are in a stable state of health, has received a complete authorized/approved vaccine series (primary series + booster either with homologous or heterologous vaccine products) \>/ = 16 weeks prior to enrollment. Subjects will be stratified by i) age (18-64 years and = 65 years of age) (however arms 16 and 17 or stage 4 will only enroll participants between the ages of 18-49 years) and ii) history of confirmed prior SARS-CoV-2 infection, and randomly assigned to receive one of several variant vaccines. Enrollment will target a goal of approximately 45% of each of the variant vaccine arms to be in older adults (= 65 years of age) for stages 1, 2 and 3 and approximately 20% to have had confirmed COVID-19 for all 4 stages. The primary objective is to evaluate humoral immune responses of candidate SARS-CoV-2 variant vaccines, alone or in combination.

Detailed description

This phase 2 clinical trial will evaluate the safety and immunogenicity of additional doses of prototype and variant (alone or in combination) vaccine candidates in previously vaccinated participants with or without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and will evaluate innate, cellular, and humoral immune responses to inform on how to shift the immune response to cover new variants as they emerge. A randomized open-label, non-placebo controlled, multi-site, multi-stage clinical trial in individuals, 18 years of age and older, who are in a stable state of health, has received a complete authorized/approved vaccine series (primary series + booster either with homologous or heterologous vaccine products) \>/= 16 weeks prior to enrollment. Subjects will be stratified by i) age (18-64 years and = 65 years of age) (however arms 16 and 17 or stage 4 will only enroll participants between the ages of 18-49 years) and ii) history of confirmed prior SARS-CoV-2 infection, and randomly assigned to receive one of several variant vaccines. Enrollment will target a goal of approximately 45% of each of the variant vaccine arms to be in older adults (= 65 years of age) for stages 1, 2 and 3 and approximately 20% to have had confirmed COVID-19 for all 4 stages. This is an adaptive design and may add arms of new vaccine platforms and/or variant lineage spike vaccines as needed. The study arms will be conducted in different stages (that could overlap) depending on public health needs and the availability of study products (starting with the available mRNA vaccines). The primary objective is to evaluate humoral immune responses of candidate SARS-CoV-2 variant vaccines, alone or in combination. The secondary objective is to evaluate the safety of candidate SARS-CoV-2 variant vaccines, as assessed by: a) Local and systemic solicited Adverse Events for 7 days following each vaccine dose; b) Unsolicited Adverse Events from Dose 1 to 28 days following each vaccine dose; c) Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interests (AESIs), New Onset of Chronic Medical (NOCMCs) and Adverse Events (AEs) leading to withdrawal from the study from Dose 1 to 12 months after last vaccine dose.

Interventions

DRUGAS03

AS03 oil-in-water emulsion adjuvant.

BIOLOGICALBNT162b2

A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2.

BIOLOGICALBNT162b2 (B.1.1.529)

A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain.

BIOLOGICALBNT162b2 (B.1.351)

A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.351 (Beta) variant SARS-CoV-2 strain.

BIOLOGICALBNT162b2 bivalent (wildtype and Omicron BA.1)

A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer. Contains mRNA that encodes for the prefusion stabilized S protein of the Omicron BA.1 variant SARS-CoV-2 strain and the ancestral strain of SARS-CoV-2.

BIOLOGICALBNT162b2 bivalent (wildtype and Omicron BA.4/BA.5)

A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer. Contains mRNA that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the ancestral strain of SARS-CoV-2.

BIOLOGICALCoV2 preS dTM [B.1.351]

Is a liquid formulation made of recombinant protein placed in a formulation buffer that contains the spike protein sequence of the B.1.351 (Beta) variant SARS-CoV-2 strain.

BIOLOGICALCoV2 preS dTM/D614

Is a liquid formulation made of recombinant protein placed in a formulation buffer. The antigen solution contains the spike protein sequence of the ancestral strain of SARS-CoV-2.

BIOLOGICALCoV2 preS dTM/D614+B.1.351

Is a liquid formulation made of recombinant protein placed in a formulation buffer contains the spike protein sequences of the ancestral and B.1.351 (Beta) variant SARS-CoV-2 strains

BIOLOGICALmRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).

BIOLOGICALmRNA-1273.351

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike (S) protein of the B.1.351 variant SARS-CoV-2 strain.

BIOLOGICALmRNA-1273.529

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain.

BIOLOGICALmRNA-1273.617.2

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.617.2 (Delta) variant SARS-CoV-2 strain.

OTHERSodium Chloride, 0.9%

0.9% Sodium Chloride Injection

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Participants must meet all of the following criteria to be eligible to participate in this study: 1. Individuals \> / = 18 years of age at the time of consent. (18-49 years for stage 4). 2. Confirmed receipt of a complete primary and booster COVID-19 vaccine series, either homologous or heterologous, with an FDA authorized/approved vaccine at least 16 weeks prior to study vaccine dose 1. 3. Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures. 4. Determined by medical history, targeted physical examination and clinical judgement of the investigator to be in stable state of health. Note: Participants with pre-existing stable chronic medical conditions defined as condition not requiring significant change in therapy or hospitalization for worsening disease within 4 weeks from enrollment, can be included at the discretion of the investigator.

Exclusion criteria

Participants meeting any of the following criteria will be excluded from the study: 1. Confirmed SARS-CoV-2 infection \< 16 weeks prior to any study vaccine dose. 2. Pregnant and breastfeeding participants. 3. Prior administration of an investigational coronavirus vaccine at any time or SARS-CoV-2 immunoglobulin, monoclonal antibody or plasma antibody therapy in the preceding 3 months. Note: subjects that participated in clinical trials of products that are now FDA approved/authorized are allowed to participate. 4. Current/planned simultaneous participation in another interventional study or receipt of any investigational study product within 28 days prior to vaccine study dose(s). 5. A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine, polyethylene glycol (PEG), polysorbate or nanolipid particles. 6. A history of myocarditis or pericarditis at any time prior to enrollment (for subjects in stages 1, 2 and 4). 7. Received or plans to receive a vaccine within 28 days prior to or after any dose of study vaccine. Note: Receipt of seasonal influenza vaccine is allowed at any time. 8. Bleeding disorder diagnosed by a healthcare provider (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or bleeding difficulties with intramuscular injections or blood draws. 9. Current or previous diagnosis of an immunocompromising condition or other immunosuppressive condition. 10. Advanced liver or kidney diseases. 11. Advanced (CD4 count \< 200) and/or untreated HIV, untreated Hepatitis B or untreated Hepatitis C. 12. Received oral, intramuscular or intravenous systemic immunosuppressants, or immune-modifying drugs for \>14 days in total within 6 months prior to any study vaccine dose (for corticosteroids = 20 mg \> / = day of prednisone equivalent). Note: Topical medications are allowed. 13. Received immunoglobulin or blood-derived products, within 3 months prior any study vaccine dose. 14. Received chemotherapy, immunotherapy or radiation therapy within 6 months prior to any study vaccine dose. 15. Study personnel or an immediate family member or household member of study personnel. 16. Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as \> / = 38.0 degrees Celsius/100.4 degrees Fahrenheit). Participants meeting this criterion may be rescheduled within the relevant window periods. Note: Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator, as long as the illness is not suggestive of COVID-19. 17. Plan to receive a COVID-19 booster vaccine outside of the study within the next 180 days. (for subjects in Stage 4 only)

Design outcomes

Primary

MeasureTime frameDescription
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422GMR to D614G variant of Pseudovirus Neutralization Against BA.4/BA.5. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366GMR to D614G variant of Pseudovirus Neutralization Against B.1.351. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422GMR to D614G variant of Pseudovirus Neutralization Against B.1.351. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366GMR to D614G variant of Pseudovirus Neutralization Against B.1.617.2. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422GMR to D614G variant of Pseudovirus Neutralization Against B.1.617.2. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366GMR to D614G variant of Pseudovirus Neutralization Against BA.1. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422GMR to D614G variant of Pseudovirus Neutralization Against BA.1. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 1 Pre-Booster Dose, Day 15GMR to D614G variant of Pseudovirus Neutralization Against BA.2.12.1. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366GMR to D614G variant of Pseudovirus Neutralization Against BA.4/BA.5. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.2.12.1 in One Dose Groups.Day 15Pseudovirus Neutralization From Baseline Against BA.2.12.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5.
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 29, Day 91, Day 181, Day 271, Day 366Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 29, Day 91, Day 181, Day 271, Day 366Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 29, Day 91, Day 181, Day 271, Day 366Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 15, Day 29, Day 91, Day 181, Day 271, Day 366Pseudovirus Neutralization From Baseline Against D614G. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Pseudovirus Neutralization From Baseline Against D614G. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 15, Day 29, Day 91, Day 181, Day 271, Day 366Pseudovirus Neutralization From Baseline Against B.1.351. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Pseudovirus Neutralization From Baseline Against B.1.351. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 15, Day 29, Day 91, Day 181, Day 271, Day 366Pseudovirus Neutralization From Baseline Against B.1.617.2. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Pseudovirus Neutralization From Baseline Against B.1.617.2. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 15, Day 29, Day 91, Day 181, Day 271, Day 366Pseudovirus Neutralization From Baseline Against BA.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value The geometric mean of the fold rise is then reported
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Pseudovirus Neutralization From Baseline Against BA.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 15, Day 29, Day 91, Day 181, Day 271, Day 366Pseudovirus Neutralization From Baseline Against BA.4/BA.5. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Pseudovirus Neutralization From Baseline Against BA.4/BA.5. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.
Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1 Pre-Booster Dose, Day 29, Day 91, Day 181, Day 271, Day 366Geometric Mean (GM) AUC of Antibody Against Wa-1. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units\*1/dilution.
Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.Day 1 Pre-Booster Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Geometric Mean (GM) AUC of Antibody Against Wa-1. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units\*1/dilution.
Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1 Pre-Booster Dose, Day 29, Day 91, Day 181, Day 271, Day 366Geometric Mean (GM) AUC of Antibody Against B.1.351. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units\*1/dilution.
Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.Day 1 Pre-Booster Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Geometric Mean (GM) AUC of Antibody Against B.1.351. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units\*1/dilution.
Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 1 Pre-Booster Dose, Day 29, Day 91, Day 181, Day 271, Day 366Geometric Mean (GM) AUC of Antibody Against BA.1. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units\*1/dilution.
Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.Day 1 Pre-Booster Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Geometric Mean (GM) AUC of Antibody Against BA.1. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units\*1/dilution.
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351.
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351.
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2.
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2.
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1.
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1.
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 1 Pre-Booster Dose, Day 15Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1.
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5.

Secondary

MeasureTime frameDescription
Frequency of Any Adverse Events of Special Interest (AESIs)Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.Number of participants that experienced any AESI during the course of the study.
Frequency of Any Medically Attended Adverse Events (MAAEs)Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.Number of participants that experienced any MAAE during the course of the study. Medically Attended Adverse Events (MAAEs) are defined as a hospitalization \< 24 hours, emergency room visit or an otherwise unscheduled visit to or from medical personnel for any reason; and considered related or possibly related to study product
Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.Number of participants that experienced any NOCMC during the course of the study.
Frequency of Any Serious Adverse Events (SAEs)Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.Number of participants that experienced any SAEs during the course of the study. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)Day 1 through Day 8 for Arms 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, and 17 and through 7 days post any vaccination for Arm 3.Number of participants who experienced any systemic solicited AEs through 7 days post any vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever.
Frequency of Local Solicited Reactogenicity Adverse Events (AEs)Day 1 through Day 8 for Arms 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, and 17 and through 7 days post any vaccination for Arm 3.Number of participants who experienced any local solicited AEs through 7 days post any vaccination. Local events include: Injection Site Pain, Injection site Erythema, and Injection site Edema/Induration.
Frequency of Any Unsolicited Adverse Events (AEs)Day 1 through Day 29 for Arms 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, and 17 and 28 days post any vaccination for Arm 3.Number of participants that experienced any Unsolicited AEs through 28 days post vaccination.
Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.Number of participants that experienced any AE during the course of the study that resulted in withdrawal from the study.

Countries

United States

Participant flow

Participants by arm

ArmCount
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
mRNA-1273 administered through 0.2 mg/ml intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=100 mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV). Sodium Chloride, 0.9%: 0.9% Sodium Chloride Injection
99
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
0.1 mg/ml of mRNA-1273.351 and 0.2 mg/ml of mRNA-1273.529 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=100 mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike (S) protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.529: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain. Sodium Chloride, 0.9%: 0.9% Sodium Chloride Injection
113
Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses)
0.1 mg/ml of mRNA-1273.351 and 0.2 mg/ml of mRNA-1273.529 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 and Day 57 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=100 mRNA-1273.351: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike (S) protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.529: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain. Sodium Chloride, 0.9%: 0.9% Sodium Chloride Injection
86
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
0.2 mg/ml of mRNA-1273.617.2 and 0.2 mg/ml of mRNA-1273.529 administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=100 mRNA-1273.529: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain. mRNA-1273.617.2: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.617.2 (Delta) variant SARS-CoV-2 strain. Sodium Chloride, 0.9%: 0.9% Sodium Chloride Injection
101
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
0.2 mg/ml of mRNA-1273.529 administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=100 mRNA-1273.529: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain. Sodium Chloride, 0.9%: 0.9% Sodium Chloride Injection
99
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
0.2 mg/ml of mRNA-1273.529 and mRNA-1273 0.2 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=100 mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV). mRNA-1273.529: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain. Sodium Chloride, 0.9%: 0.9% Sodium Chloride Injection
99
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
500 mcg/mL of BNT162b2 (Wildtype \[Prototype\]) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=50 BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2.
50
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
500 mcg/mL of BNT162b2 (Beta) and 500 mcg/mL of BNT162b2 (Omicron) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=50 BNT162b2 (B.1.1.529): A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain. BNT162b2 (B.1.351): A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.351 (Beta) variant SARS-CoV-2 strain.
52
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
500 mcg/mL of BNT162b2 (Omicron) administered through intramuscular injection in the deltoid muscle on Day 1 and Day 57 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=50 BNT162b2 (B.1.1.529): A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain.
54
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
500 mcg/mL of BNT162b2 (Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=50 BNT162b2 (B.1.351): A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.351 (Beta) variant SARS-CoV-2 strain.
51
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
500 mcg/mL of BNT162b2 (Beta) and 500 mcg/mL of BNT162b2 (Wildtype \[Prototype\]) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=50 BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. BNT162b2 (B.1.351): A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.351 (Beta) variant SARS-CoV-2 strain.
52
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
500 mcg/mL of BNT162b2 (Omicron) and 500 mcg/mL of BNT162b2 (Wildtype \[Prototype\]) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=50 BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. BNT162b2 (B.1.1.529): A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529 (Omicron) variant SARS-CoV-2 strain.
53
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
500 mcg/mL CoV2 preS dTM-AS03 \[D614\] (prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=50 AS03: AS03 oil-in-water emulsion adjuvant. CoV2 preS dTM/D614: Is a liquid formulation made of recombinant protein placed in a formulation buffer. The antigen solution contains the spike protein sequence of the ancestral strain of SARS-CoV-2.
49
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
500 mcg/mL CoV2 preS dTM-AS03 \[B.1.351\] (Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=50 AS03: AS03 oil-in-water emulsion adjuvant. CoV2 preS dTM \[B.1.351\]: Is a liquid formulation made of recombinant protein placed in a formulation buffer that contains the spike protein sequence of the B.1.351 (Beta) variant SARS-CoV-2 strain.
51
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
500 mcg/mL CoV2 preS dTM-AS03 \[D614 + B.1.351\] (prototype + Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; \> / = 65 years (\ 45% in \> / = 65 years) N=50 AS03: AS03 oil-in-water emulsion adjuvant. CoV2 preS dTM/D614+B.1.351: Is a liquid formulation made of recombinant protein placed in a formulation buffer contains the spike protein sequences of the ancestral and B.1.351 (Beta) variant SARS-CoV-2 strains
52
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
100 mcg/mL BNT162b2 bivalent (wildtype and Omicron BA.1) + Wildtype (Prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 49 years; N=100 BNT162b2 bivalent (wildtype and Omicron BA.1): A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer. Contains mRNA that encodes for the prefusion stabilized S protein of the Omicron BA.1 variant SARS-CoV-2 strain and the ancestral strain of SARS-CoV-2.
101
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
100 mcg/mL BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5) + Wildtype (Prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 49 years; N=100 BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5): A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer. Contains mRNA that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the ancestral strain of SARS-CoV-2.
101
Total1,263

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013FG014FG015FG016
Overall StudyDeath00000100000000100
Overall StudyDid not receive vaccine03001110000000100
Overall StudyLost to Follow-up14333232213427464
Overall StudyProtocol deviation00000000000000010
Overall StudyUnable to make last visit00100000000000000
Overall StudyWithdrawal by Subject70331521221012033

Baseline characteristics

CharacteristicStage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses)Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Total
Age, Continuous51.8 years
STANDARD_DEVIATION 16.9
53 years
STANDARD_DEVIATION 16.3
51.7 years
STANDARD_DEVIATION 17.5
52.2 years
STANDARD_DEVIATION 17.5
50.7 years50.8 years
STANDARD_DEVIATION 17.6
50.3 years
STANDARD_DEVIATION 18.1
48.7 years
STANDARD_DEVIATION 16.4
53.9 years
STANDARD_DEVIATION 16.4
49.9 years
STANDARD_DEVIATION 16.1
48 years
STANDARD_DEVIATION 17.9
51.7 years
STANDARD_DEVIATION 16
42.9 years
STANDARD_DEVIATION 18.5
48.7 years
STANDARD_DEVIATION 15.6
46.5 years
STANDARD_DEVIATION 14.7
31.7 years
STANDARD_DEVIATION 8.1
32.2 years
STANDARD_DEVIATION 8.8
47.6 years
STANDARD_DEVIATION 17.4
Age, Customized
18-64 years
75 Participants54 Participants65 Participants64 Participants65 Participants35 Participants36 Participants38 Participants64 Participants36 Participants35 Participants38 Participants39 Participants40 Participants43 Participants101 Participants101 Participants929 Participants
Age, Customized
>=65 years
38 Participants32 Participants36 Participants35 Participants34 Participants15 Participants16 Participants16 Participants35 Participants15 Participants17 Participants15 Participants10 Participants11 Participants9 Participants0 Participants0 Participants334 Participants
BMI27.38 kg/m^2
STANDARD_DEVIATION 5.95
27.17 kg/m^2
STANDARD_DEVIATION 5.4
27.27 kg/m^2
STANDARD_DEVIATION 5.41
27.17 kg/m^2
STANDARD_DEVIATION 5.69
27.14 kg/m^2
STANDARD_DEVIATION 5.46
26.38 kg/m^2
STANDARD_DEVIATION 3.51
28.17 kg/m^2
STANDARD_DEVIATION 6.45
26.81 kg/m^2
STANDARD_DEVIATION 6.78
28.69 kg/m^2
STANDARD_DEVIATION 5.41
28.42 kg/m^2
STANDARD_DEVIATION 6.11
27.54 kg/m^2
STANDARD_DEVIATION 6.33
28.88 kg/m^2
STANDARD_DEVIATION 5.98
25.87 kg/m^2
STANDARD_DEVIATION 5.91
28.85 kg/m^2
STANDARD_DEVIATION 6.7
27.77 kg/m^2
STANDARD_DEVIATION 6.35
26.95 kg/m^2
STANDARD_DEVIATION 5.58
27.18 kg/m^2
STANDARD_DEVIATION 6.15
27.47 kg/m^2
STANDARD_DEVIATION 5.83
Days Since Most Recent COVID19 Vaccine165.5 days
STANDARD_DEVIATION 27.7
175.5 days
STANDARD_DEVIATION 23.8
170.3 days
STANDARD_DEVIATION 29.3
173.2 days
STANDARD_DEVIATION 28.1
168.6 days
STANDARD_DEVIATION 27.2
195.5 days
STANDARD_DEVIATION 33.6
196.6 days
STANDARD_DEVIATION 34.2
200.2 days
STANDARD_DEVIATION 35.6
172.8 days
STANDARD_DEVIATION 32.3
207.5 days
STANDARD_DEVIATION 31.7
207.2 days
STANDARD_DEVIATION 29.3
198.3 days
STANDARD_DEVIATION 34.6
205.9 days
STANDARD_DEVIATION 38.1
194.3 days
STANDARD_DEVIATION 40.9
210.9 days
STANDARD_DEVIATION 41.2
332.5 days
STANDARD_DEVIATION 44.5
334 days
STANDARD_DEVIATION 66.1
208.2 days
STANDARD_DEVIATION 67.3
Days Since Most Recent Self-Reported COVID19 Infection327.7 days
STANDARD_DEVIATION 206.1
358.7 days
STANDARD_DEVIATION 246.8
329.4 days
STANDARD_DEVIATION 214.2
425.9 days
STANDARD_DEVIATION 243.3
334.1 days
STANDARD_DEVIATION 198.4
240.8 days
STANDARD_DEVIATION 174.1
373.1 days
STANDARD_DEVIATION 280.1
242.8 days
STANDARD_DEVIATION 139.4
389.1 days
STANDARD_DEVIATION 236
250.8 days
STANDARD_DEVIATION 163.8
314.2 days
STANDARD_DEVIATION 251.1
219.2 days
STANDARD_DEVIATION 192
224.7 days
STANDARD_DEVIATION 174.4
224.4 days
STANDARD_DEVIATION 93.4
275.1 days
STANDARD_DEVIATION 235.5
292.1 days
STANDARD_DEVIATION 197.1
304.5 days
STANDARD_DEVIATION 191.7
301.3 days
STANDARD_DEVIATION 204.3
Days Since Most Recent Self-Reported COVID19 Infection or COVID19 Vaccine162.5 days
STANDARD_DEVIATION 28.1
173.5 days
STANDARD_DEVIATION 25.8
167.8 days
STANDARD_DEVIATION 30.3
170.8 days
STANDARD_DEVIATION 30
166.7 days
STANDARD_DEVIATION 27.6
190.5 days
STANDARD_DEVIATION 37.3
189.2 days
STANDARD_DEVIATION 38.5
193.4 days
STANDARD_DEVIATION 40
169.2 days
STANDARD_DEVIATION 33.8
198.3 days
STANDARD_DEVIATION 38.3
196.8 days
STANDARD_DEVIATION 38.1
188.9 days
STANDARD_DEVIATION 40.5
195.1 days
STANDARD_DEVIATION 44.1
183.4 days
STANDARD_DEVIATION 40.5
195.4 days
STANDARD_DEVIATION 47.9
269.8 days
STANDARD_DEVIATION 82.3
274 days
STANDARD_DEVIATION 83.2
193.6 days
STANDARD_DEVIATION 58.2
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants1 Participants7 Participants7 Participants5 Participants4 Participants6 Participants9 Participants5 Participants2 Participants3 Participants1 Participants8 Participants5 Participants4 Participants17 Participants21 Participants116 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
102 Participants85 Participants94 Participants92 Participants94 Participants45 Participants46 Participants45 Participants94 Participants49 Participants49 Participants52 Participants41 Participants46 Participants48 Participants84 Participants80 Participants1146 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Prior Infection (Positive Nuclear Protein Antibody or Self-Report)
No
90 Participants71 Participants84 Participants76 Participants79 Participants33 Participants34 Participants36 Participants78 Participants33 Participants37 Participants35 Participants27 Participants31 Participants32 Participants21 Participants25 Participants822 Participants
Prior Infection (Positive Nuclear Protein Antibody or Self-Report)
Yes
23 Participants15 Participants17 Participants23 Participants20 Participants17 Participants18 Participants18 Participants21 Participants18 Participants15 Participants18 Participants22 Participants20 Participants20 Participants80 Participants76 Participants441 Participants
Prior Infection (Self-Report)
No
93 Participants77 Participants86 Participants84 Participants84 Participants39 Participants40 Participants41 Participants84 Participants39 Participants40 Participants40 Participants34 Participants36 Participants36 Participants42 Participants41 Participants936 Participants
Prior Infection (Self-Report)
Yes
20 Participants9 Participants15 Participants15 Participants15 Participants11 Participants12 Participants13 Participants15 Participants12 Participants12 Participants13 Participants15 Participants15 Participants16 Participants59 Participants60 Participants327 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants2 Participants6 Participants
Race (NIH/OMB)
Asian
8 Participants6 Participants6 Participants7 Participants9 Participants5 Participants9 Participants9 Participants5 Participants5 Participants6 Participants6 Participants9 Participants4 Participants4 Participants11 Participants16 Participants125 Participants
Race (NIH/OMB)
Black or African American
6 Participants6 Participants6 Participants4 Participants10 Participants5 Participants2 Participants3 Participants12 Participants5 Participants5 Participants2 Participants3 Participants9 Participants4 Participants10 Participants12 Participants104 Participants
Race (NIH/OMB)
More than one race
2 Participants0 Participants8 Participants2 Participants1 Participants1 Participants2 Participants3 Participants2 Participants2 Participants3 Participants1 Participants0 Participants0 Participants6 Participants7 Participants4 Participants44 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants2 Participants0 Participants1 Participants3 Participants2 Participants12 Participants
Race (NIH/OMB)
White
94 Participants74 Participants81 Participants85 Participants78 Participants38 Participants39 Participants39 Participants79 Participants39 Participants38 Participants44 Participants35 Participants38 Participants37 Participants68 Participants65 Participants971 Participants
SARS-COV-2 Vaccination Regimen
Ad26 Primary, Ad26 Boost
0 Participants1 Participants1 Participants0 Participants2 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants1 Participants1 Participants8 Participants
SARS-COV-2 Vaccination Regimen
Ad26 Primary, mRNA Boost
6 Participants3 Participants5 Participants4 Participants1 Participants0 Participants0 Participants0 Participants4 Participants1 Participants0 Participants2 Participants2 Participants0 Participants2 Participants6 Participants6 Participants42 Participants
SARS-COV-2 Vaccination Regimen
mRNA Primary, mRNA Boost
107 Participants82 Participants95 Participants95 Participants96 Participants50 Participants52 Participants54 Participants95 Participants50 Participants52 Participants51 Participants46 Participants50 Participants50 Participants94 Participants94 Participants1213 Participants
Sex: Female, Male
Female
65 Participants48 Participants52 Participants53 Participants49 Participants24 Participants27 Participants30 Participants50 Participants28 Participants28 Participants31 Participants33 Participants30 Participants27 Participants56 Participants58 Participants689 Participants
Sex: Female, Male
Male
48 Participants38 Participants49 Participants46 Participants50 Participants26 Participants25 Participants24 Participants49 Participants23 Participants24 Participants22 Participants16 Participants21 Participants25 Participants45 Participants43 Participants574 Participants

Adverse events

Event typeEG000
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
deaths
Total, all-cause mortality
0 / 990 / 1990 / 860 / 1010 / 991 / 990 / 500 / 520 / 540 / 510 / 520 / 530 / 490 / 511 / 520 / 1010 / 101
other
Total, other adverse events
98 / 99185 / 19976 / 8698 / 10194 / 9989 / 9946 / 5047 / 5249 / 5442 / 5148 / 5251 / 5342 / 4946 / 5149 / 5296 / 10194 / 101
serious
Total, serious adverse events
4 / 994 / 1996 / 862 / 1013 / 992 / 990 / 500 / 521 / 541 / 515 / 521 / 531 / 491 / 511 / 520 / 1010 / 101

Outcome results

Primary

Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.

Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2712.83 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 294.66 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3662.50 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.81 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1811.87 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 294.31 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.85 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1811.90 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3662.31 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2712.59 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 294.50 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2712.79 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1811.92 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.99 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3662.26 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3662.18 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 294.96 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 913.28 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.05 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2712.90 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.04 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2712.70 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 294.28 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.83 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 913.00 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 293.59 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.71 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.58 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.19 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2712.69 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2712.42 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 913.31 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 295.31 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1811.91 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.81 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.34 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2711.95 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 294.35 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.85 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1811.85 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 913.76 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 295.58 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.46 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2713.15 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.98 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.06 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3662.10 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2712.64 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 913.48 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 295.25 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 913.06 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1811.65 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.86 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2712.23 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 295.01 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 911.77 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.48 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2712.12 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 292.31 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1811.82 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2712.46 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.29 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.50 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 293.07 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.68 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2712.09 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.12 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.45 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 292.68 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.15 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1811.69 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 293.59 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2711.35 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.23 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.16 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.16 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 293.75 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2711.37 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1811.97 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.55 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.

Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.Day 4222.15 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.Day 295.30 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.Day 574.07 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.Day 856.61 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.Day 1474.55 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.Day 2373.44 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.Day 3272.91 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.

Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 295.24 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.80 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.06 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1811.90 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3662.33 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.64 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 294.95 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.05 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3662.24 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1811.94 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1811.93 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3662.27 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.95 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.36 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 295.35 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1812.20 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3662.29 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 296.19 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2713.17 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.87 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 295.30 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1812.17 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.90 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3661.87 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.38 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 293.89 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.52 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1812.24 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3661.55 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 912.51 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.58 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.65 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1812.18 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 296.37 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3661.90 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3661.55 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 295.71 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.43 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.25 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1812.22 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 296.20 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2713.15 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3662.14 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.93 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1812.44 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.48 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.65 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1812.04 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 295.64 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3662.07 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 296.03 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.17 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.31 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1811.90 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3661.95 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.30 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3661.38 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 911.95 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 292.67 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1811.88 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 912.32 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3661.46 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.40 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1812.30 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 293.36 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.06 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1812.03 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 912.08 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 292.86 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3661.36 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 912.65 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1811.87 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 294.48 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2711.37 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3661.19 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 294.81 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 1812.05 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 3661.13 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 912.82 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.Day 2711.32 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.

Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.Day 295.96 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.Day 574.69 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.Day 857.99 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.Day 1475.28 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.Day 2373.47 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.Day 3272.91 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.Day 4222.03 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.

Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 294.57 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2712.41 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.59 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.85 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3662.01 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2712.05 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.75 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.88 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.42 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 293.61 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.73 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.85 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 293.78 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2712.19 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.65 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.74 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 293.87 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2712.41 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.78 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.86 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 293.67 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2712.18 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.90 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.61 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.55 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1812.04 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 293.25 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.43 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.44 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2712.23 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.68 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.62 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.52 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 293.75 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2711.97 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.65 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.26 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.43 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 293.55 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2711.72 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 294.25 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 913.03 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1812.16 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2712.60 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.74 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 294.09 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.93 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.64 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2712.16 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.72 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.47 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.50 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 294.19 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2711.81 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.61 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.71 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 911.72 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2711.92 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 292.24 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.31 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.41 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.95 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2712.05 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 292.59 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.22 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 911.93 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.28 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2711.75 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 292.30 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.89 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2711.20 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.46 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 293.05 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.06 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.03 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 293.29 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 912.28 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 1811.68 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 2711.25 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.Day 3661.08 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.

Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.Day 2372.68 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.Day 3272.31 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.Day 4221.75 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.Day 294.09 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.Day 573.02 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.Day 854.85 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.Day 1473.74 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.

Pseudovirus Neutralization From Baseline Against B.1.351. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 04 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 295.69 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.41 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3663.62 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 159.47 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 914.31 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2714.15 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 299.14 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1813.35 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3663.67 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2714.89 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 916.73 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1512.48 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1813.26 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 297.72 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1511.51 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2714.50 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 916.34 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3663.22 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1813.62 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3663.33 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1512.01 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2714.70 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 298.20 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 917.18 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 916.96 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1814.36 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 297.15 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1511.23 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3663.50 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2715.11 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2714.70 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3663.36 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 294.30 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1813.01 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 155.70 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.35 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.61 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3663.22 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 158.02 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 913.71 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 297.53 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2714.21 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2713.39 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 159.67 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 299.31 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 914.67 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.86 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3662.76 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2715.09 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 299.22 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1510.69 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1813.25 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3664.10 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 914.65 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 296.77 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3663.46 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2713.94 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 913.53 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.28 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 158.11 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 914.71 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 298.52 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1813.03 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3664.84 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1510.42 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2715.21 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.94 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 152.05 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 292.86 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2713.94 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3663.04 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.90 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1815.31 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 155.91 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3664.79 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2717.86 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 918.23 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2910.37 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 153.14 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 295.10 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1813.89 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2714.26 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3663.15 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 913.72 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 155.50 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1811.95 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.41 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.16 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 294.84 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2711.20 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 2711.23 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 295.68 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 912.72 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 3661.45 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 156.63 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.Day 1812.07 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.

Pseudovirus Neutralization From Baseline Against B.1.351. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported

Time frame: Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.Day 1513.31 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.Day 299.27 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.Day 577.10 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.Day 8512.37 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.Day 1475.98 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.Day 2376.60 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.Day 3275.17 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.Day 4224.49 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.

Pseudovirus Neutralization From Baseline Against B.1.617.2. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported

Time frame: Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 294.80 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2712.97 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 913.25 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 157.22 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1811.79 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3662.55 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 914.46 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2713.07 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3662.45 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1812.03 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 157.26 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 295.29 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3662.29 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1812.16 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 158.18 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 914.45 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 296.02 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2712.80 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1811.86 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3661.96 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2712.66 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 913.85 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 294.40 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 156.10 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 157.89 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2713.04 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 295.51 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 915.01 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3662.27 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1812.41 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1812.23 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 293.73 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 912.22 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 154.50 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2712.72 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3662.45 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 295.19 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1811.72 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 912.59 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3662.28 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2712.28 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 154.95 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2711.92 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3661.82 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 154.93 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 294.72 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 912.81 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1811.83 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2712.72 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3662.53 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 294.90 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 155.15 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 912.57 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1811.81 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 294.82 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2712.17 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1811.71 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3662.59 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 912.34 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 155.15 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2712.59 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 295.65 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 156.54 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 913.07 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3663.18 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1811.88 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 292.15 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3661.88 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 912.07 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 151.37 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2712.34 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1811.81 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 295.32 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 914.17 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3662.96 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 152.86 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1813.06 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2713.73 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 293.55 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2712.53 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1812.54 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3662.44 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 912.59 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 151.93 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 294.04 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3661.54 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 911.88 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1811.65 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2711.29 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 154.41 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 3661.61 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 155.00 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 912.28 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 2711.34 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 1811.85 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.Day 294.48 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.

Pseudovirus Neutralization From Baseline Against B.1.617.2. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported

Time frame: Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.Day 156.72 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.Day 294.98 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.Day 574.15 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.Day 856.60 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.Day 1473.32 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.Day 2373.43 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.Day 3272.61 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.Day 4222.64 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.

Pseudovirus Neutralization From Baseline Against BA.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value The geometric mean of the fold rise is then reported

Time frame: Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1510.10 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 296.84 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1812.72 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3664.84 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 914.12 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2715.77 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2912.75 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2718.21 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1815.23 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1516.85 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 918.18 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3667.30 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1814.52 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1516.34 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2911.63 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2718.76 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3667.18 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 917.84 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 916.94 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3665.94 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1517.50 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1814.84 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2912.07 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2717.40 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2718.20 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1515.32 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3665.64 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2910.40 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 917.24 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1815.17 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3664.75 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 155.93 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.02 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2716.42 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 293.81 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1814.08 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 916.27 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1512.07 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2717.53 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1814.20 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3667.10 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 298.26 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1514.51 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3666.36 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2911.70 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1815.32 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2716.14 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 919.44 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1814.84 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3666.56 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2717.09 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 916.44 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1512.23 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 298.49 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3666.67 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 297.07 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 159.37 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 915.15 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2715.54 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1813.66 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 918.01 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 299.40 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1515.15 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1815.15 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 36611.14 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2718.36 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 292.59 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.02 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1814.58 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2716.35 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 152.98 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3665.13 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1817.92 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 156.74 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 298.72 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 916.29 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2717.00 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3666.75 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1816.17 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3665.86 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2716.26 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 294.94 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 154.28 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.91 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1812.95 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 913.52 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3662.24 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.33 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 294.70 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 155.95 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 156.49 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 295.10 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 2712.33 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 3662.09 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 1813.23 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.Day 914.02 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.

Pseudovirus Neutralization From Baseline Against BA.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.Day 2912.96 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.Day 1517.18 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.Day 579.08 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.Day 8516.67 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.Day 14710.48 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.Day 2378.78 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.Day 3278.29 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.Day 4228.79 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.2.12.1 in One Dose Groups.

Pseudovirus Neutralization From Baseline Against BA.2.12.1. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 15

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 who did not receive second dose were analyzed as part of Stage 1 - Arm 02. BA.2.12.1 was only tested on a subset of groups and visits because it was superseded by other variants of concern.

ArmMeasureValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.2.12.1 in One Dose Groups.10.84 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.2.12.1 in One Dose Groups.9.34 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.2.12.1 in One Dose Groups.11.84 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.2.12.1 in One Dose Groups.9.01 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.2.12.1 in One Dose Groups.8.65 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.

Pseudovirus Neutralization From Baseline Against BA.4/BA.5. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 296.56 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 914.82 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1813.36 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1512.31 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 2718.95 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 3668.16 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 918.98 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 36610.49 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1816.08 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 27111.67 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1510.06 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 2910.34 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 918.63 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 36610.03 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1516.19 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1815.21 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 2911.93 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 27111.05 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 916.64 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1815.29 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 3668.47 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 159.20 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 2719.92 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 298.45 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 299.88 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 27112.73 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 918.01 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1512.25 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 3668.58 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1816.83 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 27110.41 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 913.96 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1815.80 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 294.21 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 36610.05 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 298.39 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1814.84 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 3669.73 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 916.96 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 27110.18 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 916.65 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 3666.70 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 299.51 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1814.92 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 2717.00 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 36610.95 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 27111.20 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 299.40 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 158.45 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 916.49 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1815.92 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1815.07 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 2719.77 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 916.55 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 36613.41 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 299.72 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 36613.61 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 298.75 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 2719.69 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 917.07 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1815.85 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1815.39 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 293.68 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 2718.60 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 3667.36 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 153.10 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 913.22 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 296.57 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 916.41 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1818.48 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 3669.19 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 2718.79 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 155.54 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 154.37 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1816.86 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 914.81 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 2718.53 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 3668.73 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 295.46 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 2712.31 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 154.65 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 912.77 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 294.03 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 3662.35 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1812.71 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 3662.88 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 296.64 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 158.04 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 915.27 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 1814.34 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.Day 2713.24 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.

Pseudovirus Neutralization From Baseline Against BA.4/BA.5. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.Day 578.51 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.Day 8515.55 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.Day 1540.80 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.Day 2910.61 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.Day 1479.05 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.Day 23711.11 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.Day 32711.06 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.Day 42211.68 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.

Pseudovirus Neutralization From Baseline Against D614G. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1812.05 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 913.50 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 294.80 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 156.49 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3662.77 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2713.44 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3662.29 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1812.00 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 155.41 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2713.41 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 913.74 fold rise
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 294.25 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 914.45 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3662.44 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 156.88 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1812.52 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 295.07 fold rise
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2713.54 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 913.70 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3662.09 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2713.09 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 293.77 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1811.97 fold rise
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 154.98 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 157.31 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 294.97 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3662.60 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2713.59 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1812.85 fold rise
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 914.71 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 911.92 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3662.59 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 293.45 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2712.82 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 154.27 fold rise
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1812.61 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 294.25 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2712.24 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 153.99 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 912.03 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3662.20 fold rise
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1811.82 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 912.11 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 293.85 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3661.73 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1811.82 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 153.98 fold rise
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2711.86 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1812.18 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3662.76 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 294.25 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2713.10 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 912.29 fold rise
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 155.11 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1811.99 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 912.19 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 294.46 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2712.21 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3662.88 fold rise
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 154.89 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 156.12 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1812.23 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 912.48 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2712.39 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3663.08 fold rise
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 295.09 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1812.36 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 151.57 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2712.43 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 292.00 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3662.43 fold rise
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 912.21 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1813.02 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 913.75 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 152.82 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3663.65 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 294.26 fold rise
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2713.44 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3662.43 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2712.30 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1812.48 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 912.20 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 151.84 fold rise
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 292.72 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2711.23 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3661.08 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 911.93 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 153.69 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1811.46 fold rise
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 294.20 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 2711.33 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 3661.13 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 912.46 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 154.33 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 1811.57 fold rise
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.Day 294.64 fold rise
Primary

Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.

Pseudovirus Neutralization From Baseline Against D614G. Fold-rise is calculated by dividing post-vaccination results by the baseline value. The geometric mean of the fold rise is then reported.

Time frame: Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.Day 293.81 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.Day 573.33 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.Day 2373.73 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.Day 3272.67 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.Day 4223.02 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.Day 155.35 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.Day 854.88 fold rise
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.Day 1472.97 fold rise
Primary

Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.

Geometric Mean (GM) AUC of Antibody Against B.1.351. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units\*1/dilution.

Time frame: Day 1 Pre-Booster Dose, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91260600.97 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366221467.29 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181173909.68 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271258643.48 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29436540.44 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 193551.19 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1129906.22 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271328407.16 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29536040.87 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366288113.03 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181237513.05 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91353154.19 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181228919.38 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91337018.67 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1116649.05 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366267894.35 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271331083.82 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29497454.13 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181238062.10 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1115206.13 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271336408.76 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366249713.10 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91368777.24 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29522838.44 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91364466.11 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366247236.94 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1128531.47 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271338933.50 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29510066.75 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181258839.20 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366243160.36 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271408169.15 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29468813.37 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181303657.19 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1135763.15 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91343409.80 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1104424.42 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271242648.32 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91339016.33 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29499652.43 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181192668.11 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366181309.72 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29441732.81 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366156958.86 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1110265.46 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91304500.86 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181219015.58 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271222230.23 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181245072.17 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1100277.89 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271294022.31 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29536875.49 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91358322.49 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366200084.98 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271311998.19 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366253664.70 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1121192.68 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91395543.34 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29535912.15 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181263281.28 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1135028.37 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91396620.95 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29590251.89 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181234800.63 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271284552.50 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366231244.70 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29327932.05 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271315964.73 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181275654.28 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1150238.68 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91264515.83 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366227063.40 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271312951.39 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366216318.74 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181300882.56 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29386837.28 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1134064.73 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91315462.53 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29359000.12 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271300475.72 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1139963.38 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366215517.27 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181287091.71 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91296474.19 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29479928.00 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1136025.14 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271190613.29 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181235298.55 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366164587.63 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91307530.83 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 181280572.85 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 1144727.88 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 366163821.61 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 271199914.23 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 91360330.74 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.Day 29547431.70 Arbitrary Units*1/Dilution
Primary

Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.

Geometric Mean (GM) AUC of Antibody Against B.1.351. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units\*1/dilution.

Time frame: Day 1 Pre-Booster Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.Day 85601632.71 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.Day 199752.03 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.Day 29467456.52 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.Day 57383162.27 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.Day 147440762.25 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.Day 237339450.17 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.Day 327290896.60 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.Day 422217113.45 Arbitrary Units*1/Dilution
Primary

Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.

Geometric Mean (GM) AUC of Antibody Against BA.1. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units\*1/dilution.

Time frame: Day 1 Pre-Booster Dose, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 27199192.03 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29191702.35 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 135858.62 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36679561.28 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91111776.32 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 18167934.34 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29245795.04 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 366105460.05 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 271131888.79 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 150667.27 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 18195644.75 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91150303.44 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 271139325.91 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 146101.27 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29243857.48 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 18189619.90 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 366106503.48 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91154578.88 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91168167.22 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 18196998.27 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36699354.35 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 143880.60 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29268727.94 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 271139410.13 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 181103752.38 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 148636.02 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36692964.28 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29245471.75 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91163330.96 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 271139473.50 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 181117299.54 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 271149877.01 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36685243.80 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 153148.74 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91130887.24 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29199576.30 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 137332.20 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29228987.60 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91131524.99 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 18178601.03 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 27195340.03 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36667777.11 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 27192710.85 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36663755.85 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 139668.84 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29216259.20 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 18196217.34 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91138870.07 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 18188377.85 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36678292.70 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91142416.99 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29215235.97 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 136466.06 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 271112221.17 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91165935.22 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29253784.67 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 271122393.65 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 146523.96 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36695692.23 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 181100149.77 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 271122432.06 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91174816.63 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29343044.44 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 181108679.49 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36697653.95 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 156154.79 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 271127066.31 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 155708.69 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91108504.45 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 181106506.21 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29140177.75 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36678559.42 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36670561.84 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 181122787.89 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 271120389.82 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91119334.36 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 151579.87 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29168689.34 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91110503.80 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 271117354.27 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36676460.37 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 181107521.40 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29152376.48 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 153338.07 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 18193570.97 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36661045.92 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91131000.91 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29219690.36 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 148508.52 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 27170720.41 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 27166434.87 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 181102367.44 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 150242.30 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 91140386.22 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 36654849.37 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.Day 29242501.72 Arbitrary Units*1/Dilution
Primary

Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.

Geometric Mean (GM) AUC of Antibody Against BA.1. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units\*1/dilution.

Time frame: Day 1 Pre-Booster Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.Day 139029.80 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.Day 29232195.94 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.Day 57184155.65 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.Day 85303406.48 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.Day 147206168.23 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.Day 237132219.79 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.Day 327112933.35 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.Day 42279707.84 Arbitrary Units*1/Dilution
Primary

Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.

Geometric Mean (GM) AUC of Antibody Against Wa-1. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units\*1/dilution.

Time frame: Day 1 Pre-Booster Dose, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271390584.35 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91438337.91 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1160130.96 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29643473.03 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366310610.18 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181298887.11 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366372637.70 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29733522.42 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91491732.55 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271431882.28 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1207723.16 Arbitrary Units*1/Dilution
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181353554.44 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91514596.59 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1202202.73 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181347652.35 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29751245.45 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271452851.99 Arbitrary Units*1/Dilution
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366377586.71 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29727260.22 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366350750.36 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181367923.35 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91500148.94 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1196631.40 Arbitrary Units*1/Dilution
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271475740.12 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29732226.74 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91536531.50 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366357990.63 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271466559.85 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181395234.07 Arbitrary Units*1/Dilution
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1212964.59 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181478836.67 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1235396.11 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271580706.90 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29659275.24 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91548300.07 Arbitrary Units*1/Dilution
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366345763.94 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181294887.23 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1182053.56 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366266067.35 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91461530.27 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271346700.48 Arbitrary Units*1/Dilution
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29657238.13 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91391247.40 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366231315.61 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1170171.30 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29552682.55 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181301817.71 Arbitrary Units*1/Dilution
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271301421.05 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91448950.77 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366272137.87 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181320772.07 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29668859.02 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1165049.51 Arbitrary Units*1/Dilution
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271394254.66 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271421371.41 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181385153.46 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29780465.85 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366332233.81 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91514233.46 Arbitrary Units*1/Dilution
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1187732.35 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1225024.80 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181334355.35 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29828997.70 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366303821.76 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91556630.53 Arbitrary Units*1/Dilution
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271383558.51 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1232208.85 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91398264.81 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181417943.47 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29480315.31 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271442185.42 Arbitrary Units*1/Dilution
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366319747.17 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271414729.20 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181396620.26 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29495494.62 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1207078.95 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91428565.45 Arbitrary Units*1/Dilution
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366281475.15 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29494440.20 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91438037.58 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1223811.30 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366301625.72 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181394207.59 Arbitrary Units*1/Dilution
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271394141.46 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91442103.46 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271271252.94 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366239959.56 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181324842.08 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1216940.66 Arbitrary Units*1/Dilution
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29626852.32 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 91510417.03 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 271286565.58 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 366242634.48 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 29751965.51 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 1227685.26 Arbitrary Units*1/Dilution
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.Day 181383432.41 Arbitrary Units*1/Dilution
Primary

Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.

Geometric Mean (GM) AUC of Antibody Against Wa-1. The assay result, reported in arbitrary units, was repeated over a series of dilutions (e.g. 1/10, 1/100, 1/1000). These data were plotted, with dilution factor (1/dilution) on the x-axis and assay result on the y-axis, and the AUC was calculated as the area under the assay results from each dilution. As the x-axis of this AUC calculation was the dilution factor and the y-axis was the assay result in arbitrary units, the calculated AUC has units of arbitrary units\*1/dilution.

Time frame: Day 1 Pre-Booster Dose, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.Day 147582298.62 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.Day 1170503.26 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.Day 29606554.56 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.Day 57494683.51 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.Day 85762319.06 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.Day 237447713.57 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.Day 327395463.67 Arbitrary Units*1/Dilution
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.Day 422302772.82 Arbitrary Units*1/Dilution
Primary

Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.

Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.8 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 157678.4 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 294815.7 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1812033.2 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 913575.3 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2713423.4 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3662857.4 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 11069.4 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1513422.2 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2715039.4 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 917029.6 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 299771.6 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1813466.0 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3663796.1 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2713938.1 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 296919.2 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 915685.7 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3662829.1 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1812804.2 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1862.6 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 159926.8 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 297551.7 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1813370.8 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1511214.3 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2714442.3 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 916703.6 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1933.8 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3663126.2 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1814008.9 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1963.6 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3663498.5 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1510820.3 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2714766.7 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 916534.1 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 296790.7 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 11223.6 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2717104.4 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3664782.9 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 157611.7 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1814110.3 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 295266.4 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 912742.8 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1812625.3 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 11056.9 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 158476.8 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3663221.4 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 297961.0 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2714105.5 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 913778.1 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2713133.2 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1812624.9 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1922.8 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 298652.2 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 914135.7 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3662377.1 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 158830.1 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2714943.1 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1813150.5 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1977.0 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1510447.5 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 299007.8 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 914507.0 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3664056.6 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 159901.1 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 914316.6 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 298014.2 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3663906.0 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2714537.9 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1812791.2 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 11183.1 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 914879.2 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 299167.2 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1511367.9 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 11065.4 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1813566.1 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3664325.9 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2715236.9 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 11426.0 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1814227.2 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3664472.8 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 914194.0 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 294081.5 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2715853.2 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 152849.5 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2716449.5 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 916814.3 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 155099.4 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1814814.4 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1863.5 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 298285.2 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3663796.0 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 915876.1 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1816141.5 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 11556.0 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 155075.6 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 298103.0 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3665337.7 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2717143.7 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 12821.0 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2913674.7 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3664041.5 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1515520.2 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2713588.4 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1815741.9 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 916168.0 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1816041.1 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1519051.8 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 12871.5 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3664026.9 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 917758.5 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2713622.5 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2916252.8 titer
Primary

Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.

Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 1847.0 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 1511275.7 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 2375362.8 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 3274295.6 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 297800.2 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 576008.9 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 8510285.2 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 1475061.1 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 4223780.4 titer
Primary

Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.

Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2714773.6 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1511566.9 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 11602.4 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 915329.5 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 297899.3 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3663949.6 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1812933.9 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 11842.0 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2715270.2 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1813564.8 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1513447.7 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 917977.7 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 299742.0 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3664289.1 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1813824.7 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2911005.1 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 918256.9 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1514581.1 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 11783.4 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3664011.9 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2714992.4 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 917267.3 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2715022.5 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 11898.6 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3663690.3 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1511575.4 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 298256.2 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1813499.3 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 918651.8 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3664186.9 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 11771.4 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 299696.2 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1814143.8 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2715294.9 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1513975.9 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 12261.3 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 914874.8 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1510868.1 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1815684.5 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 298444.4 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3666333.9 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2717566.2 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 158689.0 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 914253.7 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2713649.7 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 299095.1 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 11753.6 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3663663.3 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1812797.9 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1813337.3 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2713360.2 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3663161.0 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 914854.3 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 298504.4 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 158705.4 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 11775.8 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3664490.3 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 914709.7 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2714730.2 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 159519.2 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 11849.3 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 299067.6 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1813323.3 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 915475.8 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1814026.4 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1512004.8 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2714792.7 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2910754.4 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3665671.3 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 12232.5 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3665700.1 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2911738.3 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1814109.5 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2715104.3 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1513331.1 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 12032.3 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 916208.7 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 12679.5 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 915543.9 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3665301.9 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 295768.5 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2716223.0 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1814968.0 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 153666.9 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 11750.1 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 917065.7 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 298746.4 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 155005.2 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1815343.6 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2715963.9 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3664295.2 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 916475.1 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3666388.3 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 12493.9 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 154820.9 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1816290.0 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 298863.7 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2716591.1 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1514610.6 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2714604.6 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2913482.3 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 916349.1 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 13315.7 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3665333.6 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1815798.8 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2916409.4 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1518199.3 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 13637.2 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2715006.9 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1816884.7 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 918184.0 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3665745.6 titer
Primary

Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.

Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 859866.0 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 1475012.4 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 2375004.8 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 11508.5 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 1510135.8 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 297478.5 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 576256.1 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 3273856.0 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 4223919.6 titer
Primary

Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.

Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 291863.8 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1264.4 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 152669.9 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2711552.1 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3661235.0 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 911095.3 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 181741.1 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 155278.9 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3662217.1 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2712453.0 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1811583.8 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1311.2 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 912492.5 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 293967.2 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 912234.9 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3661987.9 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1278.1 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 293320.9 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1811226.9 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 154544.2 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2712403.2 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2712549.8 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1343.8 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 156014.6 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 293994.1 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 912382.6 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1811634.9 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3662012.2 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1811721.4 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 155339.3 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 912460.1 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1348.4 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3662032.1 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 293520.8 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2712770.2 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1420.3 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3662218.4 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2713236.6 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 152662.2 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 911228.7 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1811801.7 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 291602.1 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 292532.9 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3661998.1 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1811214.8 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1306.8 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 911851.5 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 153753.3 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2712107.2 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1811859.4 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 913011.7 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3661943.4 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 293852.6 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 154781.7 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1329.8 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2711995.1 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1811299.1 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 153315.5 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3661824.1 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2711902.3 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1271.2 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 911728.7 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 292301.1 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 292547.3 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1811413.4 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1360.2 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 911895.6 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2712000.0 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3662355.2 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 153570.4 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 912726.7 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3663247.7 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 155544.3 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1346.4 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1812021.5 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2712744.7 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 293285.6 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3662270.8 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 151221.8 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1413.6 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 291071.7 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 911247.1 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1811939.9 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2712654.2 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 151966.6 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2712027.9 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1291.6 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3661985.3 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 292367.4 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 911756.6 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1812541.8 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1812310.1 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 911471.8 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2712463.5 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3662335.7 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 291824.4 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 151636.0 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1366.2 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 11103.1 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 295211.8 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3662538.8 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 156558.3 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1813361.6 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2712818.0 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 913954.1 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 295056.7 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3662007.4 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2712401.5 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 11002.9 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 913963.2 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1813263.9 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 156511.2 titer
Primary

Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.

Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 293235.4 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 572322.2 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 854111.6 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 1249.7 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 154289.3 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 1472616.7 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 2372088.0 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 3272006.1 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 4222136.6 titer
Primary

Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.

Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1.

Time frame: Day 1 Pre-Booster Dose, Day 15

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 who did not receive second dose were analyzed as part of Stage 1 - Arm 02. BA.2.12.1 was only tested on a subset of groups and visits because it was superseded by other variants of concern.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 151879.9 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 1173.5 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 1209.1 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 151952.8 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 152569.9 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 1217.0 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 1352.9 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 153181.1 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 1345.2 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 152986.1 titer
Primary

Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.

Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1155.3 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3661208.4 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 181538.3 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 291035.7 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 91756.3 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2711437.9 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 151214.7 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 151349.8 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1170.8 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3661793.9 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2711951.1 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1811028.3 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 291766.3 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 911503.2 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2711733.1 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1152.0 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 151812.1 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 291850.9 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 911367.4 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 181801.2 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3661567.6 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 152036.2 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 291631.5 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1195.4 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1811037.4 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 911297.3 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3661633.8 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2711950.2 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 911363.4 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 151832.5 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2712023.5 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 291665.5 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1811117.8 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3661472.2 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1174.0 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 91785.8 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3662378.5 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1206.8 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2712655.1 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1811327.5 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 29870.9 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2711451.4 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 911032.5 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 291303.8 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1155.3 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3661378.2 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 181707.8 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2711290.0 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1183.7 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 291754.5 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 911221.7 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 181971.0 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3661180.6 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1148.6 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 291397.6 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 15169.0 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3661628.2 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 91950.7 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 181868.4 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2711620.4 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3661972.5 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2711468.9 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 911021.8 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 181824.6 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1150.1 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 291458.4 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1811199.9 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 291680.7 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 911313.7 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3662122.8 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1184.0 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2711727.2 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 91830.6 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2712211.5 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1257.6 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3661993.5 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1811460.0 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 29948.1 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 15767.3 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 291274.8 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1195.6 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3661628.0 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 151084.3 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 911201.3 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2711670.7 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1811805.7 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1254.8 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3662319.4 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 151144.8 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1811765.8 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 911247.7 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2712263.3 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 291463.9 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 293104.8 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1812099.7 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3661770.2 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 153577.0 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 912163.2 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1768.6 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2711843.8 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 155906.9 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2712419.0 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1735.1 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1813189.2 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3662041.4 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 913774.7 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 294881.1 titer
Primary

Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.

Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 2371407.5 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 3271419.5 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 4221569.2 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 1132.1 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 15816.0 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 291416.8 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 571148.9 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 852029.1 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 1471195.3 titer
Primary

Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.

Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1816903.6 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1521060.3 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 27111298.3 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 13245.3 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 3668671.6 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2915972.1 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 9111701.1 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2916815.7 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1521523.4 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 3668756.9 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 27112807.0 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 13959.5 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1817562.1 titer
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 9114410.2 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 3668552.4 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2918250.6 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 27112567.4 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 9116558.4 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1818909.5 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1524323.2 titer
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 13537.5 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 27111943.9 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1519304.9 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 13874.1 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2914380.9 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 9114296.6 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1817621.8 titer
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 3668065.4 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2917680.2 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1819964.2 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 13595.9 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1526279.7 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 27112712.9 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 9116567.5 titer
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 3669784.4 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 27115654.4 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2916440.9 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 18113012.4 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 36613214.9 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 918878.3 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 14761.5 titer
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1521566.8 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 13720.3 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 3667644.9 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2915825.6 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1514986.8 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1816369.6 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 917168.4 titer
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2717715.8 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2915451.6 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1515842.2 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 13982.2 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 3666661.2 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1817294.8 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 918157.4 titer
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2717211.2 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 13687.5 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 27110557.7 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 918344.8 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1518854.6 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1817954.9 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 3669652.1 titer
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2915674.6 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2919718.1 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 36612279.8 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1819107.1 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 14423.3 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2719559.5 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1522458.9 titer
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 9110091.6 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2924139.0 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1528322.2 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 14686.6 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 9111463.3 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 18110985.5 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 27110701.5 titer
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 36612341.7 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 15196.7 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 36613314.0 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2910390.1 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 158102.7 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 9111464.2 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 18112634.3 titer
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 27112557.1 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 9112503.4 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 27110729.0 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 159670.5 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 36610449.0 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2913898.2 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 18110278.3 titer
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 13432.5 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 18113441.8 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 9111949.2 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 36614255.0 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2914825.3 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 27113065.9 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 159982.9 titer
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 15419.9 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1527493.0 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2931502.1 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 3668366.7 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 18111401.6 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 17448.8 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 9114685.9 titer
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2719755.4 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 9118941.5 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 3668509.6 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 1533715.5 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 18112407.1 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 17786.8 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 2936372.7 titer
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.Day 27110562.7 titer
Primary

Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.

Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.Day 3278859.3 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.Day 42210156.6 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.Day 13358.3 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.Day 1517962.2 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.Day 2912816.7 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.Day 5711171.5 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.Day 8516328.8 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.Day 1479988.4 titer
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.Day 23712128.0 titer
Primary

Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.

GMR to D614G variant of Pseudovirus Neutralization Against B.1.351. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.36 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.25 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.33 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.30 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.31 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.29 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.30 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.49 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.39 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.46 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.62 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.27 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.43 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.58 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.31 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.24 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.41 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.38 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.34 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.31 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.33 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.53 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.47 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.58 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.24 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.37 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.39 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.44 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.41 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.37 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.40 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.39 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.27 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.38 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.36 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.26 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.36 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.35 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.31 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.45 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.32 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.32 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.42 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.41 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.50 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.28 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.57 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.53 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.53 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.43 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.56 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.36 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.36 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.51 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.23 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.56 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.55 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.57 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.54 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.40 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.47 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.42 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.26 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.31 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.32 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.44 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.47 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.41 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.43 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.27 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.40 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.32 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.35 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.38 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.49 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.43 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.23 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.37 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.47 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.39 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.33 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.35 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.34 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.27 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.36 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.60 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.25 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.47 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.60 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.53 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.54 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.51 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.29 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.49 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.55 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.46 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.55 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.37 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.48 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.56 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.43 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.37 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.38 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.42 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.50 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 910.41 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 150.57 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 3660.47 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 2710.34 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 10.37 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 290.45 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.Day 1810.49 ratio
Primary

Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.

GMR to D614G variant of Pseudovirus Neutralization Against B.1.351. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 10.25 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 150.63 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 290.61 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 570.54 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 850.63 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 1470.51 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 2370.44 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 3270.48 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.Day 4220.37 ratio
Primary

Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.

GMR to D614G variant of Pseudovirus Neutralization Against B.1.617.2. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.49 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.55 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.46 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.42 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.49 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.42 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.46 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.41 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.47 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.47 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.49 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.58 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.62 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.55 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.40 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.60 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.43 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.60 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.50 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.50 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.47 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.42 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.46 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.49 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.60 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.57 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.51 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.46 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.42 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.49 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.42 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.52 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.55 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.43 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.53 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.44 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.47 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.50 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.48 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.48 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.55 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.51 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.48 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.59 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.44 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.47 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.57 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.58 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.47 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.45 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.47 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.55 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.47 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.60 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.55 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.46 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.58 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.50 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.50 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.56 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.42 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.47 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.45 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.53 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.55 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.44 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.50 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.46 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.50 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.54 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.49 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.47 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.43 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.54 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.37 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.48 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.46 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.39 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.48 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.40 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.45 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.56 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.50 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.52 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.52 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.57 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.56 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.63 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.52 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.41 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.51 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.54 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.50 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.45 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.48 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.47 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.60 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.46 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.45 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.64 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.53 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.51 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.43 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.47 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.43 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 910.43 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 3660.68 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 1810.55 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 150.54 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 2710.47 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 290.45 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.Day 10.47 ratio
Primary

Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.

GMR to D614G variant of Pseudovirus Neutralization Against B.1.617.2. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 10.45 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 150.56 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 290.58 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 570.56 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 850.60 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 1470.50 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 2370.41 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 3270.44 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.Day 4220.39 ratio
Primary

Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.

GMR to D614G variant of Pseudovirus Neutralization Against BA.1. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.14 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.08 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.11 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.09 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.14 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.12 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.13 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.17 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.25 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.19 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.08 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.24 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.21 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.25 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.23 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.19 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.08 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.13 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.14 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.19 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.18 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.17 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.31 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.25 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.28 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.09 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.21 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.21 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.21 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.10 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.15 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.20 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.22 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.17 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.20 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.09 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.12 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.10 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.21 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.14 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.17 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.14 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.19 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.26 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.25 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.27 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.26 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.08 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.16 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.37 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.08 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.30 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.25 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.25 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.28 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.29 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.15 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.18 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.18 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.07 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.16 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.19 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.21 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.21 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.13 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.19 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.19 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.16 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.08 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.16 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.26 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.24 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.26 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.20 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.07 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.18 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.14 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.21 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.08 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.11 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.15 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.15 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.10 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.17 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.14 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.25 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.19 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.08 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.20 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.19 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.17 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.07 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.12 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.16 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.17 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.16 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.19 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.12 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.29 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.15 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.29 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.30 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.24 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.27 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.17 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 290.14 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 150.19 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 10.13 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 1810.26 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 910.21 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 2710.23 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.Day 3660.24 ratio
Primary

Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.

GMR to D614G variant of Pseudovirus Neutralization Against BA.1. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 10.07 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 150.24 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 290.25 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 570.21 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 850.25 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 1470.26 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 2370.17 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 3270.23 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.Day 4220.21 ratio
Primary

Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.

GMR to D614G variant of Pseudovirus Neutralization Against BA.2.12.1. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

Time frame: Day 1 Pre-Booster Dose, Day 15

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 who did not receive second dose were analyzed as part of Stage 1 - Arm 02. BA.2.12.1 was only tested on a subset of groups and visits because it was superseded by other variants of concern.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 10.07 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 150.11 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 10.04 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 150.13 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 10.05 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 150.12 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 150.18 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 10.06 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 10.07 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.Day 150.14 ratio
Primary

Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.

GMR to D614G variant of Pseudovirus Neutralization Against BA.4/BA.5. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 271, Day 366

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.13 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.05 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.06 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.06 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.08 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.14 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 150.07 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.15 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.20 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.04 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 150.09 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.11 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.14 ratio
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.10 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.10 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.18 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.14 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.04 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.09 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.08 ratio
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 150.08 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.16 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.14 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.09 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.20 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.11 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 150.11 ratio
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.05 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 150.09 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.11 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.09 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.16 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.15 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.08 ratio
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.05 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.09 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.05 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.04 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.10 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.17 ratio
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.18 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.08 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.14 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.18 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.19 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.11 ratio
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.04 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.05 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.13 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.15 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.18 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.11 ratio
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.18 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 150.11 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.09 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.04 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.11 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.11 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.15 ratio
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.17 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.03 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.09 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.07 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.15 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.16 ratio
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.10 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.11 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.16 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.04 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.17 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.07 ratio
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.11 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.09 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.15 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.07 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.12 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.05 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.18 ratio
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 150.09 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.10 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.06 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.16 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.18 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.16 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 150.11 ratio
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.09 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.10 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.10 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.05 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.13 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.16 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 150.11 ratio
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.17 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.10 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.18 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.19 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 150.13 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.21 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.10 ratio
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.15 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 2710.23 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 10.09 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 290.13 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 1810.26 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 910.20 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 150.18 ratio
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.Day 3660.24 ratio
Primary

Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.

GMR to D614G variant of Pseudovirus Neutralization Against BA.4/BA.5. GMR is calculated by dividing by the neutralization against D614G. The geometric mean of the ratio is then reported.

Time frame: Day 1 Pre-Booster Dose, Day 15, Day 29, Day 57, Day 85, Day 147, Day 237, Day 327, Day 422

Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood samples for immunogenicity testing for which valid results were reported. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 10.04 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 150.06 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 290.11 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 570.10 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 850.12 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 1470.12 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 2370.12 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 3270.16 ratio
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.Day 4220.15 ratio
Secondary

Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.

Number of participants that experienced any AE during the course of the study that resulted in withdrawal from the study.

Time frame: Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.

Population: The Safety Analysis population for the study includes all participants who received at least one dose of vaccine. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.1 Participants
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.1 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.0 Participants
Secondary

Frequency of Any Adverse Events of Special Interest (AESIs)

Number of participants that experienced any AESI during the course of the study.

Time frame: Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.

Population: The Safety Analysis population for the study includes all participants who received at least one dose of vaccine. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Frequency of Any Adverse Events of Special Interest (AESIs)3 Participants
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Frequency of Any Adverse Events of Special Interest (AESIs)7 Participants
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Frequency of Any Adverse Events of Special Interest (AESIs)7 Participants
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Frequency of Any Adverse Events of Special Interest (AESIs)5 Participants
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Frequency of Any Adverse Events of Special Interest (AESIs)3 Participants
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Frequency of Any Adverse Events of Special Interest (AESIs)1 Participants
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Frequency of Any Adverse Events of Special Interest (AESIs)0 Participants
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Frequency of Any Adverse Events of Special Interest (AESIs)0 Participants
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Frequency of Any Adverse Events of Special Interest (AESIs)1 Participants
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Frequency of Any Adverse Events of Special Interest (AESIs)1 Participants
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Frequency of Any Adverse Events of Special Interest (AESIs)1 Participants
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Frequency of Any Adverse Events of Special Interest (AESIs)0 Participants
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Frequency of Any Adverse Events of Special Interest (AESIs)2 Participants
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Frequency of Any Adverse Events of Special Interest (AESIs)2 Participants
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Frequency of Any Adverse Events of Special Interest (AESIs)2 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Any Adverse Events of Special Interest (AESIs)1 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Any Adverse Events of Special Interest (AESIs)2 Participants
Secondary

Frequency of Any Medically Attended Adverse Events (MAAEs)

Number of participants that experienced any MAAE during the course of the study. Medically Attended Adverse Events (MAAEs) are defined as a hospitalization \< 24 hours, emergency room visit or an otherwise unscheduled visit to or from medical personnel for any reason; and considered related or possibly related to study product

Time frame: Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.

Population: The Safety Analysis population for the study includes all participants who received at least one dose of vaccine. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Frequency of Any Medically Attended Adverse Events (MAAEs)2 Participants
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Frequency of Any Medically Attended Adverse Events (MAAEs)2 Participants
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Frequency of Any Medically Attended Adverse Events (MAAEs)1 Participants
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Frequency of Any Medically Attended Adverse Events (MAAEs)1 Participants
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Frequency of Any Medically Attended Adverse Events (MAAEs)2 Participants
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Any Medically Attended Adverse Events (MAAEs)0 Participants
Secondary

Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)

Number of participants that experienced any NOCMC during the course of the study.

Time frame: Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.

Population: The Safety Analysis population for the study includes all participants who received at least one dose of vaccine. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)2 Participants
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)8 Participants
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)4 Participants
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)5 Participants
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)3 Participants
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)1 Participants
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)2 Participants
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)5 Participants
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)5 Participants
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)0 Participants
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)1 Participants
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)0 Participants
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)1 Participants
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)2 Participants
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)1 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)5 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)2 Participants
Secondary

Frequency of Any Serious Adverse Events (SAEs)

Number of participants that experienced any SAEs during the course of the study. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

Time frame: Day 1 to study completion (through up to Day 366) for Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and Day 1 to study completion (through up to Day 422) for Arm 3.

Population: The Safety Analysis population for the study includes all participants who received at least one dose of vaccine. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Frequency of Any Serious Adverse Events (SAEs)4 Participants
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Frequency of Any Serious Adverse Events (SAEs)4 Participants
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Frequency of Any Serious Adverse Events (SAEs)7 Participants
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Frequency of Any Serious Adverse Events (SAEs)2 Participants
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Frequency of Any Serious Adverse Events (SAEs)3 Participants
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Frequency of Any Serious Adverse Events (SAEs)4 Participants
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Frequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Frequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Frequency of Any Serious Adverse Events (SAEs)1 Participants
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Frequency of Any Serious Adverse Events (SAEs)1 Participants
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Frequency of Any Serious Adverse Events (SAEs)5 Participants
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Frequency of Any Serious Adverse Events (SAEs)1 Participants
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Frequency of Any Serious Adverse Events (SAEs)1 Participants
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Frequency of Any Serious Adverse Events (SAEs)1 Participants
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Frequency of Any Serious Adverse Events (SAEs)1 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Any Serious Adverse Events (SAEs)0 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Any Serious Adverse Events (SAEs)0 Participants
Secondary

Frequency of Any Unsolicited Adverse Events (AEs)

Number of participants that experienced any Unsolicited AEs through 28 days post vaccination.

Time frame: Day 1 through Day 29 for Arms 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, and 17 and 28 days post any vaccination for Arm 3.

Population: The Safety Analysis population for the study includes all participants who received at least one dose of vaccine. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Frequency of Any Unsolicited Adverse Events (AEs)26 Participants
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Frequency of Any Unsolicited Adverse Events (AEs)40 Participants
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Frequency of Any Unsolicited Adverse Events (AEs)39 Participants
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Frequency of Any Unsolicited Adverse Events (AEs)31 Participants
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Frequency of Any Unsolicited Adverse Events (AEs)35 Participants
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Frequency of Any Unsolicited Adverse Events (AEs)33 Participants
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Frequency of Any Unsolicited Adverse Events (AEs)17 Participants
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Frequency of Any Unsolicited Adverse Events (AEs)12 Participants
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Frequency of Any Unsolicited Adverse Events (AEs)14 Participants
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Frequency of Any Unsolicited Adverse Events (AEs)13 Participants
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Frequency of Any Unsolicited Adverse Events (AEs)19 Participants
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Frequency of Any Unsolicited Adverse Events (AEs)16 Participants
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Frequency of Any Unsolicited Adverse Events (AEs)15 Participants
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Frequency of Any Unsolicited Adverse Events (AEs)13 Participants
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Frequency of Any Unsolicited Adverse Events (AEs)11 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Any Unsolicited Adverse Events (AEs)33 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Any Unsolicited Adverse Events (AEs)28 Participants
Secondary

Frequency of Local Solicited Reactogenicity Adverse Events (AEs)

Number of participants who experienced any local solicited AEs through 7 days post any vaccination. Local events include: Injection Site Pain, Injection site Erythema, and Injection site Edema/Induration.

Time frame: Day 1 through Day 8 for Arms 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, and 17 and through 7 days post any vaccination for Arm 3.

Population: The Safety Analysis population for the study includes all participants who received at least one dose of vaccine. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Frequency of Local Solicited Reactogenicity Adverse Events (AEs)93 Participants
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Frequency of Local Solicited Reactogenicity Adverse Events (AEs)101 Participants
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Frequency of Local Solicited Reactogenicity Adverse Events (AEs)77 Participants
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Frequency of Local Solicited Reactogenicity Adverse Events (AEs)87 Participants
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Frequency of Local Solicited Reactogenicity Adverse Events (AEs)82 Participants
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Frequency of Local Solicited Reactogenicity Adverse Events (AEs)80 Participants
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Frequency of Local Solicited Reactogenicity Adverse Events (AEs)38 Participants
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Frequency of Local Solicited Reactogenicity Adverse Events (AEs)41 Participants
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Frequency of Local Solicited Reactogenicity Adverse Events (AEs)43 Participants
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Frequency of Local Solicited Reactogenicity Adverse Events (AEs)40 Participants
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Frequency of Local Solicited Reactogenicity Adverse Events (AEs)43 Participants
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Frequency of Local Solicited Reactogenicity Adverse Events (AEs)46 Participants
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Frequency of Local Solicited Reactogenicity Adverse Events (AEs)40 Participants
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Frequency of Local Solicited Reactogenicity Adverse Events (AEs)42 Participants
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Frequency of Local Solicited Reactogenicity Adverse Events (AEs)42 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Local Solicited Reactogenicity Adverse Events (AEs)82 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Local Solicited Reactogenicity Adverse Events (AEs)86 Participants
Secondary

Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)

Number of participants who experienced any systemic solicited AEs through 7 days post any vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever.

Time frame: Day 1 through Day 8 for Arms 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, and 17 and through 7 days post any vaccination for Arm 3.

Population: The Safety Analysis population for the study includes all participants who received at least one dose of vaccine. Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) who did not receive second dose were analyzed as part of Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)82 Participants
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)88 Participants
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)70 Participants
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)80 Participants
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)81 Participants
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)80 Participants
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)40 Participants
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)42 Participants
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)37 Participants
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)33 Participants
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)36 Participants
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)39 Participants
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)33 Participants
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)33 Participants
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)35 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)80 Participants
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)83 Participants

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026