MedDataX Logo

Trial Outcomes & Findings for COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) (NCT NCT05289037)

NCT ID: NCT05289037

Last Updated: 2025-10-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1270 participants

Primary outcome timeframe

Day 29, Day 91, Day 181, Day 271, Day 366

Results posted on

2025-10-17

Participant Flow

Participant milestones

Participant milestones
Measure
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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
Overall Study
STARTED
99
100
102
101
100
100
51
52
54
51
52
53
49
51
53
101
101
Overall Study
COMPLETED
91
93
95
95
95
91
45
49
50
48
48
49
46
42
47
91
94
Overall Study
NOT COMPLETED
8
7
7
6
5
9
6
3
4
3
4
4
3
9
6
10
7

Reasons for withdrawal

Reasons for withdrawal
Measure
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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
Overall Study
Withdrawal by Subject
7
0
3
3
1
5
2
1
2
2
1
0
1
2
0
3
3
Overall Study
Lost to Follow-up
1
4
3
3
3
2
3
2
2
1
3
4
2
7
4
6
4
Overall Study
Death
0
0
0
0
0
1
0
0
0
0
0
0
0
0
1
0
0
Overall Study
Did not receive vaccine
0
3
0
0
1
1
1
0
0
0
0
0
0
0
1
0
0
Overall Study
Unable to make last visit
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Overall Study
Protocol deviation
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0

Baseline Characteristics

COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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
Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses)
n=86 Participants
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
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=99 Participants
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
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=50 Participants
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.
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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.
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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.
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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.
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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.
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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.
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=49 Participants
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.
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=51 Participants
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.
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=101 Participants
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.
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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.
Total
n=1263 Participants
Total of all reporting groups
Age, Continuous
53.9 years
STANDARD_DEVIATION 16.4 • n=5 Participants
51.8 years
STANDARD_DEVIATION 16.9 • n=7 Participants
53 years
STANDARD_DEVIATION 16.3 • n=5 Participants
51.7 years
STANDARD_DEVIATION 17.5 • n=4 Participants
52.2 years
STANDARD_DEVIATION 17.5 • n=21 Participants
50.7 years
STANDARD_DEVIATION 18. • n=8 Participants
50.8 years
STANDARD_DEVIATION 17.6 • n=8 Participants
50.3 years
STANDARD_DEVIATION 18.1 • n=24 Participants
48.7 years
STANDARD_DEVIATION 16.4 • n=42 Participants
49.9 years
STANDARD_DEVIATION 16.1 • n=42 Participants
48 years
STANDARD_DEVIATION 17.9 • n=42 Participants
51.7 years
STANDARD_DEVIATION 16 • n=42 Participants
42.9 years
STANDARD_DEVIATION 18.5 • n=36 Participants
48.7 years
STANDARD_DEVIATION 15.6 • n=36 Participants
46.5 years
STANDARD_DEVIATION 14.7 • n=24 Participants
31.7 years
STANDARD_DEVIATION 8.1 • n=135 Participants
32.2 years
STANDARD_DEVIATION 8.8 • n=136 Participants
47.6 years
STANDARD_DEVIATION 17.4 • n=44 Participants
Age, Customized
18-64 years
64 Participants
n=5 Participants
75 Participants
n=7 Participants
54 Participants
n=5 Participants
65 Participants
n=4 Participants
64 Participants
n=21 Participants
65 Participants
n=8 Participants
35 Participants
n=8 Participants
36 Participants
n=24 Participants
38 Participants
n=42 Participants
36 Participants
n=42 Participants
35 Participants
n=42 Participants
38 Participants
n=42 Participants
39 Participants
n=36 Participants
40 Participants
n=36 Participants
43 Participants
n=24 Participants
101 Participants
n=135 Participants
101 Participants
n=136 Participants
929 Participants
n=44 Participants
Age, Customized
>=65 years
35 Participants
n=5 Participants
38 Participants
n=7 Participants
32 Participants
n=5 Participants
36 Participants
n=4 Participants
35 Participants
n=21 Participants
34 Participants
n=8 Participants
15 Participants
n=8 Participants
16 Participants
n=24 Participants
16 Participants
n=42 Participants
15 Participants
n=42 Participants
17 Participants
n=42 Participants
15 Participants
n=42 Participants
10 Participants
n=36 Participants
11 Participants
n=36 Participants
9 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
334 Participants
n=44 Participants
Sex: Female, Male
Female
50 Participants
n=5 Participants
65 Participants
n=7 Participants
48 Participants
n=5 Participants
52 Participants
n=4 Participants
53 Participants
n=21 Participants
49 Participants
n=8 Participants
24 Participants
n=8 Participants
27 Participants
n=24 Participants
30 Participants
n=42 Participants
28 Participants
n=42 Participants
28 Participants
n=42 Participants
31 Participants
n=42 Participants
33 Participants
n=36 Participants
30 Participants
n=36 Participants
27 Participants
n=24 Participants
56 Participants
n=135 Participants
58 Participants
n=136 Participants
689 Participants
n=44 Participants
Sex: Female, Male
Male
49 Participants
n=5 Participants
48 Participants
n=7 Participants
38 Participants
n=5 Participants
49 Participants
n=4 Participants
46 Participants
n=21 Participants
50 Participants
n=8 Participants
26 Participants
n=8 Participants
25 Participants
n=24 Participants
24 Participants
n=42 Participants
23 Participants
n=42 Participants
24 Participants
n=42 Participants
22 Participants
n=42 Participants
16 Participants
n=36 Participants
21 Participants
n=36 Participants
25 Participants
n=24 Participants
45 Participants
n=135 Participants
43 Participants
n=136 Participants
574 Participants
n=44 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=5 Participants
11 Participants
n=7 Participants
1 Participants
n=5 Participants
7 Participants
n=4 Participants
7 Participants
n=21 Participants
5 Participants
n=8 Participants
4 Participants
n=8 Participants
6 Participants
n=24 Participants
9 Participants
n=42 Participants
2 Participants
n=42 Participants
3 Participants
n=42 Participants
1 Participants
n=42 Participants
8 Participants
n=36 Participants
5 Participants
n=36 Participants
4 Participants
n=24 Participants
17 Participants
n=135 Participants
21 Participants
n=136 Participants
116 Participants
n=44 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
94 Participants
n=5 Participants
102 Participants
n=7 Participants
85 Participants
n=5 Participants
94 Participants
n=4 Participants
92 Participants
n=21 Participants
94 Participants
n=8 Participants
45 Participants
n=8 Participants
46 Participants
n=24 Participants
45 Participants
n=42 Participants
49 Participants
n=42 Participants
49 Participants
n=42 Participants
52 Participants
n=42 Participants
41 Participants
n=36 Participants
46 Participants
n=36 Participants
48 Participants
n=24 Participants
84 Participants
n=135 Participants
80 Participants
n=136 Participants
1146 Participants
n=44 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
1 Participants
n=44 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
1 Participants
n=135 Participants
2 Participants
n=136 Participants
6 Participants
n=44 Participants
Race (NIH/OMB)
Asian
5 Participants
n=5 Participants
8 Participants
n=7 Participants
6 Participants
n=5 Participants
6 Participants
n=4 Participants
7 Participants
n=21 Participants
9 Participants
n=8 Participants
5 Participants
n=8 Participants
9 Participants
n=24 Participants
9 Participants
n=42 Participants
5 Participants
n=42 Participants
6 Participants
n=42 Participants
6 Participants
n=42 Participants
9 Participants
n=36 Participants
4 Participants
n=36 Participants
4 Participants
n=24 Participants
11 Participants
n=135 Participants
16 Participants
n=136 Participants
125 Participants
n=44 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
1 Participants
n=135 Participants
0 Participants
n=136 Participants
1 Participants
n=44 Participants
Race (NIH/OMB)
Black or African American
12 Participants
n=5 Participants
6 Participants
n=7 Participants
6 Participants
n=5 Participants
6 Participants
n=4 Participants
4 Participants
n=21 Participants
10 Participants
n=8 Participants
5 Participants
n=8 Participants
2 Participants
n=24 Participants
3 Participants
n=42 Participants
5 Participants
n=42 Participants
5 Participants
n=42 Participants
2 Participants
n=42 Participants
3 Participants
n=36 Participants
9 Participants
n=36 Participants
4 Participants
n=24 Participants
10 Participants
n=135 Participants
12 Participants
n=136 Participants
104 Participants
n=44 Participants
Race (NIH/OMB)
White
79 Participants
n=5 Participants
94 Participants
n=7 Participants
74 Participants
n=5 Participants
81 Participants
n=4 Participants
85 Participants
n=21 Participants
78 Participants
n=8 Participants
38 Participants
n=8 Participants
39 Participants
n=24 Participants
39 Participants
n=42 Participants
39 Participants
n=42 Participants
38 Participants
n=42 Participants
44 Participants
n=42 Participants
35 Participants
n=36 Participants
38 Participants
n=36 Participants
37 Participants
n=24 Participants
68 Participants
n=135 Participants
65 Participants
n=136 Participants
971 Participants
n=44 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
8 Participants
n=4 Participants
2 Participants
n=21 Participants
1 Participants
n=8 Participants
1 Participants
n=8 Participants
2 Participants
n=24 Participants
3 Participants
n=42 Participants
2 Participants
n=42 Participants
3 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
6 Participants
n=24 Participants
7 Participants
n=135 Participants
4 Participants
n=136 Participants
44 Participants
n=44 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
2 Participants
n=36 Participants
0 Participants
n=36 Participants
1 Participants
n=24 Participants
3 Participants
n=135 Participants
2 Participants
n=136 Participants
12 Participants
n=44 Participants
Prior Infection (Self-Report)
Yes
15 Participants
n=5 Participants
20 Participants
n=7 Participants
9 Participants
n=5 Participants
15 Participants
n=4 Participants
15 Participants
n=21 Participants
15 Participants
n=8 Participants
11 Participants
n=8 Participants
12 Participants
n=24 Participants
13 Participants
n=42 Participants
12 Participants
n=42 Participants
12 Participants
n=42 Participants
13 Participants
n=42 Participants
15 Participants
n=36 Participants
15 Participants
n=36 Participants
16 Participants
n=24 Participants
59 Participants
n=135 Participants
60 Participants
n=136 Participants
327 Participants
n=44 Participants
Prior Infection (Self-Report)
No
84 Participants
n=5 Participants
93 Participants
n=7 Participants
77 Participants
n=5 Participants
86 Participants
n=4 Participants
84 Participants
n=21 Participants
84 Participants
n=8 Participants
39 Participants
n=8 Participants
40 Participants
n=24 Participants
41 Participants
n=42 Participants
39 Participants
n=42 Participants
40 Participants
n=42 Participants
40 Participants
n=42 Participants
34 Participants
n=36 Participants
36 Participants
n=36 Participants
36 Participants
n=24 Participants
42 Participants
n=135 Participants
41 Participants
n=136 Participants
936 Participants
n=44 Participants
Prior Infection (Positive Nuclear Protein Antibody or Self-Report)
Yes
21 Participants
n=5 Participants
23 Participants
n=7 Participants
15 Participants
n=5 Participants
17 Participants
n=4 Participants
23 Participants
n=21 Participants
20 Participants
n=8 Participants
17 Participants
n=8 Participants
18 Participants
n=24 Participants
18 Participants
n=42 Participants
18 Participants
n=42 Participants
15 Participants
n=42 Participants
18 Participants
n=42 Participants
22 Participants
n=36 Participants
20 Participants
n=36 Participants
20 Participants
n=24 Participants
80 Participants
n=135 Participants
76 Participants
n=136 Participants
441 Participants
n=44 Participants
Prior Infection (Positive Nuclear Protein Antibody or Self-Report)
No
78 Participants
n=5 Participants
90 Participants
n=7 Participants
71 Participants
n=5 Participants
84 Participants
n=4 Participants
76 Participants
n=21 Participants
79 Participants
n=8 Participants
33 Participants
n=8 Participants
34 Participants
n=24 Participants
36 Participants
n=42 Participants
33 Participants
n=42 Participants
37 Participants
n=42 Participants
35 Participants
n=42 Participants
27 Participants
n=36 Participants
31 Participants
n=36 Participants
32 Participants
n=24 Participants
21 Participants
n=135 Participants
25 Participants
n=136 Participants
822 Participants
n=44 Participants
SARS-COV-2 Vaccination Regimen
mRNA Primary, mRNA Boost
95 Participants
n=5 Participants
107 Participants
n=7 Participants
82 Participants
n=5 Participants
95 Participants
n=4 Participants
95 Participants
n=21 Participants
96 Participants
n=8 Participants
50 Participants
n=8 Participants
52 Participants
n=24 Participants
54 Participants
n=42 Participants
50 Participants
n=42 Participants
52 Participants
n=42 Participants
51 Participants
n=42 Participants
46 Participants
n=36 Participants
50 Participants
n=36 Participants
50 Participants
n=24 Participants
94 Participants
n=135 Participants
94 Participants
n=136 Participants
1213 Participants
n=44 Participants
SARS-COV-2 Vaccination Regimen
Ad26 Primary, mRNA Boost
4 Participants
n=5 Participants
6 Participants
n=7 Participants
3 Participants
n=5 Participants
5 Participants
n=4 Participants
4 Participants
n=21 Participants
1 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
2 Participants
n=42 Participants
2 Participants
n=36 Participants
0 Participants
n=36 Participants
2 Participants
n=24 Participants
6 Participants
n=135 Participants
6 Participants
n=136 Participants
42 Participants
n=44 Participants
SARS-COV-2 Vaccination Regimen
Ad26 Primary, Ad26 Boost
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
2 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=36 Participants
1 Participants
n=36 Participants
0 Participants
n=24 Participants
1 Participants
n=135 Participants
1 Participants
n=136 Participants
8 Participants
n=44 Participants
BMI
28.69 kg/m^2
STANDARD_DEVIATION 5.41 • n=5 Participants
27.38 kg/m^2
STANDARD_DEVIATION 5.95 • n=7 Participants
27.17 kg/m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
27.27 kg/m^2
STANDARD_DEVIATION 5.41 • n=4 Participants
27.17 kg/m^2
STANDARD_DEVIATION 5.69 • n=21 Participants
27.14 kg/m^2
STANDARD_DEVIATION 5.46 • n=8 Participants
26.38 kg/m^2
STANDARD_DEVIATION 3.51 • n=8 Participants
28.17 kg/m^2
STANDARD_DEVIATION 6.45 • n=24 Participants
26.81 kg/m^2
STANDARD_DEVIATION 6.78 • n=42 Participants
28.42 kg/m^2
STANDARD_DEVIATION 6.11 • n=42 Participants
27.54 kg/m^2
STANDARD_DEVIATION 6.33 • n=42 Participants
28.88 kg/m^2
STANDARD_DEVIATION 5.98 • n=42 Participants
25.87 kg/m^2
STANDARD_DEVIATION 5.91 • n=36 Participants
28.85 kg/m^2
STANDARD_DEVIATION 6.7 • n=36 Participants
27.77 kg/m^2
STANDARD_DEVIATION 6.35 • n=24 Participants
26.95 kg/m^2
STANDARD_DEVIATION 5.58 • n=135 Participants
27.18 kg/m^2
STANDARD_DEVIATION 6.15 • n=136 Participants
27.47 kg/m^2
STANDARD_DEVIATION 5.83 • n=44 Participants
Days Since Most Recent COVID19 Vaccine
172.8 days
STANDARD_DEVIATION 32.3 • n=5 Participants
165.5 days
STANDARD_DEVIATION 27.7 • n=7 Participants
175.5 days
STANDARD_DEVIATION 23.8 • n=5 Participants
170.3 days
STANDARD_DEVIATION 29.3 • n=4 Participants
173.2 days
STANDARD_DEVIATION 28.1 • n=21 Participants
168.6 days
STANDARD_DEVIATION 27.2 • n=8 Participants
195.5 days
STANDARD_DEVIATION 33.6 • n=8 Participants
196.6 days
STANDARD_DEVIATION 34.2 • n=24 Participants
200.2 days
STANDARD_DEVIATION 35.6 • n=42 Participants
207.5 days
STANDARD_DEVIATION 31.7 • n=42 Participants
207.2 days
STANDARD_DEVIATION 29.3 • n=42 Participants
198.3 days
STANDARD_DEVIATION 34.6 • n=42 Participants
205.9 days
STANDARD_DEVIATION 38.1 • n=36 Participants
194.3 days
STANDARD_DEVIATION 40.9 • n=36 Participants
210.9 days
STANDARD_DEVIATION 41.2 • n=24 Participants
332.5 days
STANDARD_DEVIATION 44.5 • n=135 Participants
334 days
STANDARD_DEVIATION 66.1 • n=136 Participants
208.2 days
STANDARD_DEVIATION 67.3 • n=44 Participants
Days Since Most Recent Self-Reported COVID19 Infection
389.1 days
STANDARD_DEVIATION 236 • n=5 Participants
327.7 days
STANDARD_DEVIATION 206.1 • n=7 Participants
358.7 days
STANDARD_DEVIATION 246.8 • n=5 Participants
329.4 days
STANDARD_DEVIATION 214.2 • n=4 Participants
425.9 days
STANDARD_DEVIATION 243.3 • n=21 Participants
334.1 days
STANDARD_DEVIATION 198.4 • n=8 Participants
240.8 days
STANDARD_DEVIATION 174.1 • n=8 Participants
373.1 days
STANDARD_DEVIATION 280.1 • n=24 Participants
242.8 days
STANDARD_DEVIATION 139.4 • n=42 Participants
250.8 days
STANDARD_DEVIATION 163.8 • n=42 Participants
314.2 days
STANDARD_DEVIATION 251.1 • n=42 Participants
219.2 days
STANDARD_DEVIATION 192 • n=42 Participants
224.7 days
STANDARD_DEVIATION 174.4 • n=36 Participants
224.4 days
STANDARD_DEVIATION 93.4 • n=36 Participants
275.1 days
STANDARD_DEVIATION 235.5 • n=24 Participants
292.1 days
STANDARD_DEVIATION 197.1 • n=135 Participants
304.5 days
STANDARD_DEVIATION 191.7 • n=136 Participants
301.3 days
STANDARD_DEVIATION 204.3 • n=44 Participants
Days Since Most Recent Self-Reported COVID19 Infection or COVID19 Vaccine
169.2 days
STANDARD_DEVIATION 33.8 • n=5 Participants
162.5 days
STANDARD_DEVIATION 28.1 • n=7 Participants
173.5 days
STANDARD_DEVIATION 25.8 • n=5 Participants
167.8 days
STANDARD_DEVIATION 30.3 • n=4 Participants
170.8 days
STANDARD_DEVIATION 30 • n=21 Participants
166.7 days
STANDARD_DEVIATION 27.6 • n=8 Participants
190.5 days
STANDARD_DEVIATION 37.3 • n=8 Participants
189.2 days
STANDARD_DEVIATION 38.5 • n=24 Participants
193.4 days
STANDARD_DEVIATION 40 • n=42 Participants
198.3 days
STANDARD_DEVIATION 38.3 • n=42 Participants
196.8 days
STANDARD_DEVIATION 38.1 • n=42 Participants
188.9 days
STANDARD_DEVIATION 40.5 • n=42 Participants
195.1 days
STANDARD_DEVIATION 44.1 • n=36 Participants
183.4 days
STANDARD_DEVIATION 40.5 • n=36 Participants
195.4 days
STANDARD_DEVIATION 47.9 • n=24 Participants
269.8 days
STANDARD_DEVIATION 82.3 • n=135 Participants
274 days
STANDARD_DEVIATION 83.2 • n=136 Participants
193.6 days
STANDARD_DEVIATION 58.2 • n=44 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=98 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.
Day 91
2.59 fold rise
Interval 2.18 to 3.08
2.42 fold rise
Interval 2.13 to 2.75
2.65 fold rise
Interval 2.24 to 3.13
2.74 fold rise
Interval 2.34 to 3.21
2.55 fold rise
Interval 2.17 to 3.0
2.44 fold rise
Interval 1.88 to 3.18
2.62 fold rise
Interval 2.16 to 3.16
2.43 fold rise
Interval 1.97 to 3.0
3.03 fold rise
Interval 2.47 to 3.71
2.64 fold rise
Interval 2.21 to 3.15
2.61 fold rise
Interval 2.14 to 3.19
1.72 fold rise
Interval 1.33 to 2.23
2.22 fold rise
Interval 1.7 to 2.91
1.93 fold rise
Interval 1.49 to 2.5
2.03 fold rise
Interval 1.77 to 2.34
2.28 fold rise
Interval 2.01 to 2.58
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.
Day 29
4.57 fold rise
Interval 3.85 to 5.43
3.61 fold rise
Interval 3.17 to 4.11
3.78 fold rise
Interval 3.24 to 4.4
3.87 fold rise
Interval 3.32 to 4.51
3.67 fold rise
Interval 3.15 to 4.28
3.25 fold rise
Interval 2.64 to 4.0
3.75 fold rise
Interval 3.15 to 4.45
3.55 fold rise
Interval 2.82 to 4.46
4.25 fold rise
Interval 3.55 to 5.1
4.09 fold rise
Interval 3.39 to 4.93
4.19 fold rise
Interval 3.41 to 5.15
2.24 fold rise
Interval 1.88 to 2.67
2.59 fold rise
Interval 2.06 to 3.25
2.30 fold rise
Interval 1.87 to 2.84
3.05 fold rise
Interval 2.65 to 3.5
3.29 fold rise
Interval 2.87 to 3.77
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.
Day 181
1.85 fold rise
Interval 1.51 to 2.28
1.75 fold rise
Interval 1.48 to 2.07
1.73 fold rise
Interval 1.42 to 2.1
1.86 fold rise
Interval 1.55 to 2.22
1.90 fold rise
Interval 1.57 to 2.28
2.04 fold rise
Interval 1.44 to 2.88
1.68 fold rise
Interval 1.34 to 2.1
1.65 fold rise
Interval 1.26 to 2.17
2.16 fold rise
Interval 1.63 to 2.85
1.93 fold rise
Interval 1.54 to 2.41
1.47 fold rise
Interval 1.13 to 1.92
1.71 fold rise
Interval 1.28 to 2.28
1.95 fold rise
Interval 1.47 to 2.58
1.89 fold rise
Interval 1.38 to 2.57
1.46 fold rise
Interval 1.26 to 1.69
1.68 fold rise
Interval 1.44 to 1.97
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.
Day 271
2.41 fold rise
Interval 1.93 to 3.0
2.05 fold rise
Interval 1.7 to 2.48
2.19 fold rise
Interval 1.78 to 2.69
2.41 fold rise
Interval 1.95 to 2.97
2.18 fold rise
Interval 1.78 to 2.67
2.23 fold rise
Interval 1.57 to 3.18
1.97 fold rise
Interval 1.56 to 2.5
1.72 fold rise
Interval 1.28 to 2.3
2.60 fold rise
Interval 1.91 to 3.54
2.16 fold rise
Interval 1.66 to 2.82
1.81 fold rise
Interval 1.36 to 2.41
1.92 fold rise
Interval 1.38 to 2.67
2.05 fold rise
Interval 1.54 to 2.73
1.75 fold rise
Interval 1.27 to 2.4
1.20 fold rise
Interval 1.02 to 1.41
1.25 fold rise
Interval 1.06 to 1.47
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in One Dose Groups.
Day 366
2.01 fold rise
Interval 1.65 to 2.46
1.88 fold rise
Interval 1.55 to 2.28
1.85 fold rise
Interval 1.5 to 2.29
1.78 fold rise
Interval 1.45 to 2.19
1.61 fold rise
Interval 1.32 to 1.96
1.43 fold rise
Interval 1.03 to 1.98
1.52 fold rise
Interval 1.17 to 1.97
1.26 fold rise
Interval 0.96 to 1.66
1.74 fold rise
Interval 1.28 to 2.38
1.72 fold rise
Interval 1.32 to 2.25
1.50 fold rise
Interval 1.1 to 2.05
1.31 fold rise
Interval 0.92 to 1.87
1.41 fold rise
Interval 1.07 to 1.86
1.28 fold rise
Interval 0.92 to 1.78
1.06 fold rise
Interval 0.89 to 1.25
1.08 fold rise
Interval 0.93 to 1.26
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.
Day 29
4.09 fold rise
Interval 3.48 to 4.81
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.
Day 57
3.02 fold rise
Interval 2.59 to 3.52
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.
Day 85
4.85 fold rise
Interval 4.09 to 5.75
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.
Day 147
3.74 fold rise
Interval 3.11 to 4.51
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.
Day 237
2.68 fold rise
Interval 2.16 to 3.32
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.
Day 327
2.31 fold rise
Interval 1.84 to 2.89
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against Wa-1 in Two Dose Group.
Day 422
1.75 fold rise
Interval 1.37 to 2.23
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.
Day 29
4.66 fold rise
Interval 3.93 to 5.51
4.31 fold rise
Interval 3.71 to 4.99
4.50 fold rise
Interval 3.84 to 5.29
4.96 fold rise
Interval 4.22 to 5.83
4.28 fold rise
Interval 3.58 to 5.12
3.59 fold rise
Interval 2.95 to 4.37
5.31 fold rise
Interval 4.39 to 6.41
4.35 fold rise
Interval 3.39 to 5.57
5.58 fold rise
Interval 4.63 to 6.73
5.25 fold rise
Interval 4.34 to 6.35
5.01 fold rise
Interval 4.02 to 6.25
2.31 fold rise
Interval 1.92 to 2.79
3.07 fold rise
Interval 2.42 to 3.89
2.68 fold rise
Interval 2.13 to 3.38
3.59 fold rise
Interval 3.17 to 4.07
3.75 fold rise
Interval 3.22 to 4.38
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.
Day 91
2.81 fold rise
Interval 2.33 to 3.39
2.85 fold rise
Interval 2.49 to 3.26
2.99 fold rise
Interval 2.51 to 3.56
3.28 fold rise
Interval 2.8 to 3.85
3.00 fold rise
Interval 2.52 to 3.57
2.58 fold rise
Interval 2.0 to 3.32
3.31 fold rise
Interval 2.75 to 3.99
2.85 fold rise
Interval 2.29 to 3.55
3.76 fold rise
Interval 3.09 to 4.57
3.48 fold rise
Interval 2.79 to 4.33
3.06 fold rise
Interval 2.41 to 3.87
1.77 fold rise
Interval 1.34 to 2.33
2.50 fold rise
Interval 1.93 to 3.24
2.12 fold rise
Interval 1.6 to 2.81
2.23 fold rise
Interval 1.96 to 2.54
2.55 fold rise
Interval 2.2 to 2.96
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.
Day 181
1.87 fold rise
Interval 1.52 to 2.3
1.90 fold rise
Interval 1.62 to 2.24
1.92 fold rise
Interval 1.56 to 2.35
2.05 fold rise
Interval 1.72 to 2.45
2.04 fold rise
Interval 1.69 to 2.47
2.19 fold rise
Interval 1.51 to 3.17
1.91 fold rise
Interval 1.51 to 2.42
1.85 fold rise
Interval 1.38 to 2.49
2.46 fold rise
Interval 1.86 to 3.26
2.06 fold rise
Interval 1.66 to 2.57
1.65 fold rise
Interval 1.23 to 2.22
1.82 fold rise
Interval 1.29 to 2.57
2.29 fold rise
Interval 1.73 to 3.03
2.15 fold rise
Interval 1.55 to 2.98
1.69 fold rise
Interval 1.47 to 1.95
1.97 fold rise
Interval 1.64 to 2.36
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.
Day 271
2.83 fold rise
Interval 2.25 to 3.54
2.59 fold rise
Interval 2.12 to 3.15
2.79 fold rise
Interval 2.24 to 3.47
2.90 fold rise
Interval 2.34 to 3.59
2.70 fold rise
Interval 2.16 to 3.36
2.69 fold rise
Interval 1.88 to 3.85
2.42 fold rise
Interval 1.9 to 3.09
1.95 fold rise
Interval 1.44 to 2.65
3.15 fold rise
Interval 2.3 to 4.3
2.64 fold rise
Interval 1.97 to 3.53
2.23 fold rise
Interval 1.61 to 3.1
2.12 fold rise
Interval 1.48 to 3.04
2.46 fold rise
Interval 1.83 to 3.3
2.09 fold rise
Interval 1.49 to 2.92
1.35 fold rise
Interval 1.14 to 1.59
1.37 fold rise
Interval 1.15 to 1.64
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in One Dose Groups.
Day 366
2.50 fold rise
Interval 2.01 to 3.11
2.31 fold rise
Interval 1.9 to 2.79
2.26 fold rise
Interval 1.81 to 2.82
2.18 fold rise
Interval 1.75 to 2.71
1.83 fold rise
Interval 1.49 to 2.25
1.71 fold rise
Interval 1.2 to 2.44
1.81 fold rise
Interval 1.36 to 2.42
1.34 fold rise
Interval 1.0 to 1.79
1.98 fold rise
Interval 1.44 to 2.72
2.10 fold rise
Interval 1.56 to 2.83
1.86 fold rise
Interval 1.33 to 2.61
1.48 fold rise
Interval 1.0 to 2.18
1.68 fold rise
Interval 1.25 to 2.27
1.45 fold rise
Interval 1.03 to 2.04
1.16 fold rise
Interval 0.97 to 1.38
1.16 fold rise
Interval 0.97 to 1.38
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 29
5.30 fold rise
Interval 4.49 to 6.25
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 57
4.07 fold rise
Interval 3.48 to 4.76
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 85
6.61 fold rise
Interval 5.48 to 7.97
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 147
4.55 fold rise
Interval 3.78 to 5.47
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 237
3.44 fold rise
Interval 2.74 to 4.31
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 327
2.91 fold rise
Interval 2.3 to 3.7
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 422
2.15 fold rise
Interval 1.66 to 2.77
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.
Day 91
3.06 fold rise
Interval 2.53 to 3.71
3.05 fold rise
Interval 2.64 to 3.52
3.36 fold rise
Interval 2.8 to 4.04
3.87 fold rise
Interval 3.27 to 4.58
3.38 fold rise
Interval 2.82 to 4.07
2.51 fold rise
Interval 1.91 to 3.3
3.58 fold rise
Interval 2.94 to 4.36
3.43 fold rise
Interval 2.72 to 4.32
3.93 fold rise
Interval 3.15 to 4.91
3.48 fold rise
Interval 2.76 to 4.39
3.17 fold rise
Interval 2.52 to 3.98
1.95 fold rise
Interval 1.44 to 2.64
2.32 fold rise
Interval 1.79 to 3.02
2.08 fold rise
Interval 1.57 to 2.76
2.65 fold rise
Interval 2.32 to 3.04
2.82 fold rise
Interval 2.42 to 3.29
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.
Day 29
5.24 fold rise
Interval 4.4 to 6.25
4.95 fold rise
Interval 4.22 to 5.81
5.35 fold rise
Interval 4.47 to 6.39
6.19 fold rise
Interval 5.3 to 7.24
5.30 fold rise
Interval 4.49 to 6.24
3.89 fold rise
Interval 3.16 to 4.79
6.37 fold rise
Interval 5.29 to 7.67
5.71 fold rise
Interval 4.47 to 7.3
6.20 fold rise
Interval 5.1 to 7.54
5.64 fold rise
Interval 4.54 to 7.01
6.03 fold rise
Interval 4.83 to 7.52
2.67 fold rise
Interval 2.19 to 3.26
3.36 fold rise
Interval 2.63 to 4.29
2.86 fold rise
Interval 2.28 to 3.59
4.48 fold rise
Interval 3.93 to 5.1
4.81 fold rise
Interval 4.06 to 5.69
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.
Day 181
1.90 fold rise
Interval 1.52 to 2.38
1.94 fold rise
Interval 1.63 to 2.32
1.93 fold rise
Interval 1.56 to 2.39
2.20 fold rise
Interval 1.83 to 2.65
2.17 fold rise
Interval 1.77 to 2.65
2.24 fold rise
Interval 1.53 to 3.28
2.18 fold rise
Interval 1.72 to 2.78
2.22 fold rise
Interval 1.66 to 2.95
2.44 fold rise
Interval 1.86 to 3.21
2.04 fold rise
Interval 1.6 to 2.61
1.90 fold rise
Interval 1.37 to 2.63
1.88 fold rise
Interval 1.32 to 2.69
2.30 fold rise
Interval 1.73 to 3.06
2.03 fold rise
Interval 1.47 to 2.8
1.87 fold rise
Interval 1.61 to 2.17
2.05 fold rise
Interval 1.7 to 2.47
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.
Day 271
2.80 fold rise
Interval 2.21 to 3.56
2.64 fold rise
Interval 2.14 to 3.26
2.95 fold rise
Interval 2.31 to 3.77
3.17 fold rise
Interval 2.52 to 3.98
2.90 fold rise
Interval 2.3 to 3.66
2.52 fold rise
Interval 1.75 to 3.62
2.65 fold rise
Interval 2.05 to 3.43
2.25 fold rise
Interval 1.66 to 3.07
3.15 fold rise
Interval 2.31 to 4.29
2.65 fold rise
Interval 1.96 to 3.59
2.31 fold rise
Interval 1.66 to 3.21
2.30 fold rise
Interval 1.58 to 3.35
2.40 fold rise
Interval 1.78 to 3.23
2.06 fold rise
Interval 1.47 to 2.88
1.37 fold rise
Interval 1.14 to 1.64
1.32 fold rise
Interval 1.1 to 1.59
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in One Dose Groups.
Day 366
2.33 fold rise
Interval 1.85 to 2.94
2.24 fold rise
Interval 1.81 to 2.77
2.27 fold rise
Interval 1.79 to 2.88
2.29 fold rise
Interval 1.81 to 2.91
1.87 fold rise
Interval 1.49 to 2.34
1.55 fold rise
Interval 1.09 to 2.19
1.90 fold rise
Interval 1.41 to 2.55
1.55 fold rise
Interval 1.11 to 2.17
2.14 fold rise
Interval 1.5 to 3.06
2.07 fold rise
Interval 1.52 to 2.81
1.95 fold rise
Interval 1.36 to 2.8
1.38 fold rise
Interval 0.91 to 2.09
1.46 fold rise
Interval 1.07 to 1.99
1.36 fold rise
Interval 0.95 to 1.94
1.19 fold rise
Interval 0.99 to 1.44
1.13 fold rise
Interval 0.94 to 1.37
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.
Day 29
5.96 fold rise
Interval 4.99 to 7.11
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.
Day 57
4.69 fold rise
Interval 3.94 to 5.59
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.
Day 85
7.99 fold rise
Interval 6.54 to 9.76
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.
Day 147
5.28 fold rise
Interval 4.3 to 6.49
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.
Day 237
3.47 fold rise
Interval 2.71 to 4.43
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.
Day 327
2.91 fold rise
Interval 2.24 to 3.77
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of AUC From Baseline Antibody Against BA.1 in Two Dose Group.
Day 422
2.03 fold rise
Interval 1.54 to 2.68
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.
Day 15
6.49 fold rise
Interval 5.4 to 7.81
5.41 fold rise
Interval 4.38 to 6.68
6.88 fold rise
Interval 5.29 to 8.94
4.98 fold rise
Interval 4.0 to 6.21
7.31 fold rise
Interval 5.64 to 9.47
4.27 fold rise
Interval 3.26 to 5.58
3.99 fold rise
Interval 3.15 to 5.07
3.98 fold rise
Interval 3.07 to 5.17
5.11 fold rise
Interval 3.94 to 6.63
4.89 fold rise
Interval 3.94 to 6.07
6.12 fold rise
Interval 4.34 to 8.62
1.57 fold rise
Interval 1.28 to 1.92
2.82 fold rise
Interval 1.72 to 4.63
1.84 fold rise
Interval 1.41 to 2.4
3.69 fold rise
Interval 3.1 to 4.39
4.33 fold rise
Interval 3.49 to 5.37
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.
Day 29
4.80 fold rise
Interval 3.97 to 5.8
4.25 fold rise
Interval 3.44 to 5.24
5.07 fold rise
Interval 3.87 to 6.64
3.77 fold rise
Interval 3.05 to 4.68
4.97 fold rise
Interval 3.92 to 6.29
3.45 fold rise
Interval 2.6 to 4.58
4.25 fold rise
Interval 3.09 to 5.86
3.85 fold rise
Interval 3.03 to 4.89
4.25 fold rise
Interval 3.16 to 5.72
4.46 fold rise
Interval 3.52 to 5.64
5.09 fold rise
Interval 3.63 to 7.14
2.00 fold rise
Interval 1.62 to 2.46
4.26 fold rise
Interval 2.46 to 7.36
2.72 fold rise
Interval 2.02 to 3.65
4.20 fold rise
Interval 3.55 to 4.97
4.64 fold rise
Interval 3.73 to 5.78
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.
Day 91
3.50 fold rise
Interval 2.67 to 4.58
3.74 fold rise
Interval 3.03 to 4.6
4.45 fold rise
Interval 3.46 to 5.72
3.70 fold rise
Interval 2.92 to 4.67
4.71 fold rise
Interval 3.53 to 6.29
1.92 fold rise
Interval 1.32 to 2.79
2.03 fold rise
Interval 1.51 to 2.72
2.11 fold rise
Interval 1.6 to 2.78
2.29 fold rise
Interval 1.67 to 3.13
2.19 fold rise
Interval 1.67 to 2.88
2.48 fold rise
Interval 1.73 to 3.56
2.21 fold rise
Interval 1.59 to 3.06
3.75 fold rise
Interval 2.08 to 6.76
2.20 fold rise
Interval 1.53 to 3.17
1.93 fold rise
Interval 1.64 to 2.27
2.46 fold rise
Interval 2.01 to 3.02
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.
Day 181
2.05 fold rise
Interval 1.52 to 2.76
2.00 fold rise
Interval 1.56 to 2.56
2.52 fold rise
Interval 1.88 to 3.39
1.97 fold rise
Interval 1.54 to 2.52
2.85 fold rise
Interval 2.1 to 3.87
2.61 fold rise
Interval 1.6 to 4.27
1.82 fold rise
Interval 1.28 to 2.58
1.82 fold rise
Interval 1.26 to 2.64
2.18 fold rise
Interval 1.47 to 3.24
1.99 fold rise
Interval 1.48 to 2.68
2.23 fold rise
Interval 1.43 to 3.49
2.36 fold rise
Interval 1.59 to 3.51
3.02 fold rise
Interval 1.75 to 5.21
2.48 fold rise
Interval 1.68 to 3.67
1.46 fold rise
Interval 1.2 to 1.78
1.57 fold rise
Interval 1.27 to 1.94
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.
Day 271
3.44 fold rise
Interval 2.5 to 4.73
3.41 fold rise
Interval 2.52 to 4.61
3.54 fold rise
Interval 2.6 to 4.82
3.09 fold rise
Interval 2.34 to 4.07
3.59 fold rise
Interval 2.66 to 4.86
2.82 fold rise
Interval 1.74 to 4.57
2.24 fold rise
Interval 1.62 to 3.1
1.86 fold rise
Interval 1.31 to 2.65
3.10 fold rise
Interval 2.0 to 4.82
2.21 fold rise
Interval 1.45 to 3.37
2.39 fold rise
Interval 1.7 to 3.36
2.43 fold rise
Interval 1.58 to 3.73
3.44 fold rise
Interval 1.86 to 6.36
2.30 fold rise
Interval 1.52 to 3.49
1.23 fold rise
Interval 0.99 to 1.52
1.33 fold rise
Interval 1.09 to 1.63
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in One Dose Groups.
Day 366
2.77 fold rise
Interval 2.11 to 3.63
2.29 fold rise
Interval 1.75 to 3.0
2.44 fold rise
Interval 1.85 to 3.2
2.09 fold rise
Interval 1.6 to 2.74
2.60 fold rise
Interval 1.9 to 3.55
2.59 fold rise
Interval 1.64 to 4.09
2.20 fold rise
Interval 1.53 to 3.18
1.73 fold rise
Interval 1.15 to 2.59
2.76 fold rise
Interval 1.77 to 4.29
2.88 fold rise
Interval 2.03 to 4.09
3.08 fold rise
Interval 1.96 to 4.83
2.43 fold rise
Interval 1.6 to 3.69
3.65 fold rise
Interval 1.9 to 7.0
2.43 fold rise
Interval 1.65 to 3.6
1.08 fold rise
Interval 0.87 to 1.35
1.13 fold rise
Interval 0.92 to 1.39
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.
Day 15
5.35 fold rise
Interval 4.45 to 6.43
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.
Day 29
3.81 fold rise
Interval 2.93 to 4.95
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.
Day 57
3.33 fold rise
Interval 2.78 to 3.99
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.
Day 85
4.88 fold rise
Interval 3.99 to 5.97
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.
Day 147
2.97 fold rise
Interval 2.35 to 3.76
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.
Day 237
3.73 fold rise
Interval 2.77 to 5.02
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.
Day 327
2.67 fold rise
Interval 1.98 to 3.6
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against D614G in Two Dose Group.
Day 422
3.02 fold rise
Interval 2.19 to 4.16
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.
Day 29
5.69 fold rise
Interval 4.6 to 7.04
9.14 fold rise
Interval 7.52 to 11.11
7.72 fold rise
Interval 5.82 to 10.26
8.20 fold rise
Interval 6.5 to 10.34
7.15 fold rise
Interval 5.73 to 8.92
4.30 fold rise
Interval 3.08 to 6.01
7.53 fold rise
Interval 5.4 to 10.5
9.31 fold rise
Interval 6.57 to 13.2
9.22 fold rise
Interval 6.58 to 12.92
6.77 fold rise
Interval 4.89 to 9.39
8.52 fold rise
Interval 5.7 to 12.74
2.86 fold rise
Interval 2.09 to 3.91
10.37 fold rise
Interval 5.75 to 18.71
5.10 fold rise
Interval 3.26 to 7.98
4.84 fold rise
Interval 3.99 to 5.87
5.68 fold rise
Interval 4.45 to 7.26
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.
Day 91
4.31 fold rise
Interval 3.27 to 5.69
6.73 fold rise
Interval 5.42 to 8.35
6.34 fold rise
Interval 4.71 to 8.54
7.18 fold rise
Interval 5.53 to 9.32
6.96 fold rise
Interval 5.15 to 9.41
2.35 fold rise
Interval 1.49 to 3.7
3.71 fold rise
Interval 2.53 to 5.44
4.67 fold rise
Interval 3.26 to 6.68
4.65 fold rise
Interval 3.18 to 6.81
3.53 fold rise
Interval 2.44 to 5.1
4.71 fold rise
Interval 2.93 to 7.58
2.94 fold rise
Interval 1.83 to 4.73
8.23 fold rise
Interval 4.39 to 15.42
3.72 fold rise
Interval 2.17 to 6.38
2.16 fold rise
Interval 1.77 to 2.64
2.72 fold rise
Interval 2.16 to 3.42
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.
Day 181
2.41 fold rise
Interval 1.76 to 3.29
3.35 fold rise
Interval 2.37 to 4.74
3.26 fold rise
Interval 2.36 to 4.49
3.62 fold rise
Interval 2.63 to 4.98
4.36 fold rise
Interval 3.09 to 6.15
3.01 fold rise
Interval 1.63 to 5.58
2.61 fold rise
Interval 1.71 to 4.0
2.86 fold rise
Interval 1.79 to 4.56
3.25 fold rise
Interval 2.1 to 5.03
2.28 fold rise
Interval 1.56 to 3.33
3.03 fold rise
Interval 1.76 to 5.24
2.90 fold rise
Interval 1.65 to 5.12
5.31 fold rise
Interval 2.9 to 9.71
3.89 fold rise
Interval 2.27 to 6.67
1.95 fold rise
Interval 1.51 to 2.52
2.07 fold rise
Interval 1.6 to 2.68
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.
Day 271
4.15 fold rise
Interval 2.92 to 5.91
4.89 fold rise
Interval 3.41 to 7.0
4.50 fold rise
Interval 3.22 to 6.27
4.70 fold rise
Interval 3.44 to 6.42
5.11 fold rise
Interval 3.66 to 7.15
4.70 fold rise
Interval 2.59 to 8.55
4.21 fold rise
Interval 2.79 to 6.36
3.39 fold rise
Interval 2.21 to 5.22
5.09 fold rise
Interval 3.12 to 8.29
3.94 fold rise
Interval 2.38 to 6.52
5.21 fold rise
Interval 3.11 to 8.75
3.94 fold rise
Interval 2.21 to 7.03
7.86 fold rise
Interval 4.11 to 15.02
4.26 fold rise
Interval 2.38 to 7.63
1.20 fold rise
Interval 0.93 to 1.54
1.23 fold rise
Interval 0.96 to 1.59
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.
Day 366
3.62 fold rise
Interval 2.54 to 5.15
3.67 fold rise
Interval 2.66 to 5.06
3.22 fold rise
Interval 2.35 to 4.42
3.33 fold rise
Interval 2.35 to 4.71
3.50 fold rise
Interval 2.51 to 4.89
3.36 fold rise
Interval 1.88 to 6.01
3.22 fold rise
Interval 2.03 to 5.11
2.76 fold rise
Interval 1.73 to 4.4
4.10 fold rise
Interval 2.44 to 6.91
3.46 fold rise
Interval 2.19 to 5.48
4.84 fold rise
Interval 2.74 to 8.54
3.04 fold rise
Interval 1.75 to 5.28
4.79 fold rise
Interval 2.61 to 8.81
3.15 fold rise
Interval 1.9 to 5.22
1.41 fold rise
Interval 1.08 to 1.84
1.45 fold rise
Interval 1.11 to 1.89
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in One Dose Groups.
Day 15
9.47 fold rise
Interval 7.56 to 11.86
12.48 fold rise
Interval 10.1 to 15.41
11.51 fold rise
Interval 8.75 to 15.13
12.01 fold rise
Interval 9.39 to 15.36
11.23 fold rise
Interval 8.7 to 14.49
5.70 fold rise
Interval 4.16 to 7.83
8.02 fold rise
Interval 5.8 to 11.09
9.67 fold rise
Interval 6.77 to 13.81
10.69 fold rise
Interval 7.67 to 14.91
8.11 fold rise
Interval 6.05 to 10.86
10.42 fold rise
Interval 6.84 to 15.88
2.05 fold rise
Interval 1.47 to 2.85
5.91 fold rise
Interval 3.39 to 10.29
3.14 fold rise
Interval 2.05 to 4.82
5.50 fold rise
Interval 4.52 to 6.7
6.63 fold rise
Interval 5.22 to 8.43
—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 15
13.31 fold rise
Interval 10.46 to 16.95
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 29
9.27 fold rise
Interval 7.38 to 11.64
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 57
7.10 fold rise
Interval 5.63 to 8.97
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 85
12.37 fold rise
Interval 9.48 to 16.16
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 147
5.98 fold rise
Interval 4.45 to 8.02
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 237
6.60 fold rise
Interval 4.72 to 9.22
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 327
5.17 fold rise
Interval 3.65 to 7.31
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.351 in Two Dose Group.
Day 422
4.49 fold rise
Interval 3.08 to 6.53
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.
Day 15
7.22 fold rise
Interval 5.89 to 8.84
7.26 fold rise
Interval 5.84 to 9.03
8.18 fold rise
Interval 6.25 to 10.69
6.10 fold rise
Interval 4.87 to 7.63
7.89 fold rise
Interval 6.15 to 10.12
4.50 fold rise
Interval 3.36 to 6.03
4.95 fold rise
Interval 3.8 to 6.44
4.93 fold rise
Interval 3.61 to 6.75
5.15 fold rise
Interval 3.93 to 6.74
5.15 fold rise
Interval 3.94 to 6.72
6.54 fold rise
Interval 4.69 to 9.13
1.37 fold rise
Interval 1.1 to 1.71
2.86 fold rise
Interval 1.75 to 4.68
1.93 fold rise
Interval 1.32 to 2.84
4.41 fold rise
Interval 3.71 to 5.23
5.00 fold rise
Interval 4.03 to 6.22
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.
Day 29
4.80 fold rise
Interval 3.91 to 5.9
5.29 fold rise
Interval 4.23 to 6.61
6.02 fold rise
Interval 4.61 to 7.88
4.40 fold rise
Interval 3.5 to 5.54
5.51 fold rise
Interval 4.31 to 7.05
3.73 fold rise
Interval 2.74 to 5.08
5.19 fold rise
Interval 3.78 to 7.12
4.72 fold rise
Interval 3.48 to 6.41
4.90 fold rise
Interval 3.67 to 6.56
4.82 fold rise
Interval 3.68 to 6.3
5.65 fold rise
Interval 4.08 to 7.83
2.15 fold rise
Interval 1.7 to 2.72
5.32 fold rise
Interval 3.08 to 9.17
3.55 fold rise
Interval 2.4 to 5.26
4.04 fold rise
Interval 3.43 to 4.77
4.48 fold rise
Interval 3.62 to 5.55
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.
Day 91
3.25 fold rise
Interval 2.44 to 4.33
4.46 fold rise
Interval 3.61 to 5.51
4.45 fold rise
Interval 3.41 to 5.8
3.85 fold rise
Interval 3.07 to 4.83
5.01 fold rise
Interval 3.76 to 6.67
2.22 fold rise
Interval 1.5 to 3.29
2.59 fold rise
Interval 1.88 to 3.56
2.81 fold rise
Interval 2.03 to 3.89
2.57 fold rise
Interval 1.84 to 3.58
2.34 fold rise
Interval 1.73 to 3.17
3.07 fold rise
Interval 2.12 to 4.46
2.07 fold rise
Interval 1.45 to 2.94
4.17 fold rise
Interval 2.33 to 7.47
2.59 fold rise
Interval 1.63 to 4.13
1.88 fold rise
Interval 1.58 to 2.25
2.28 fold rise
Interval 1.86 to 2.78
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.
Day 181
1.79 fold rise
Interval 1.33 to 2.42
2.03 fold rise
Interval 1.52 to 2.71
2.16 fold rise
Interval 1.63 to 2.85
1.86 fold rise
Interval 1.44 to 2.4
2.41 fold rise
Interval 1.83 to 3.18
2.23 fold rise
Interval 1.32 to 3.76
1.72 fold rise
Interval 1.22 to 2.44
1.83 fold rise
Interval 1.23 to 2.72
1.81 fold rise
Interval 1.21 to 2.71
1.71 fold rise
Interval 1.25 to 2.32
1.88 fold rise
Interval 1.22 to 2.88
1.81 fold rise
Interval 1.21 to 2.71
3.06 fold rise
Interval 1.75 to 5.37
2.54 fold rise
Interval 1.58 to 4.06
1.65 fold rise
Interval 1.35 to 2.02
1.85 fold rise
Interval 1.49 to 2.3
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.
Day 271
2.97 fold rise
Interval 2.14 to 4.13
3.07 fold rise
Interval 2.29 to 4.1
2.80 fold rise
Interval 2.08 to 3.76
2.66 fold rise
Interval 1.98 to 3.57
3.04 fold rise
Interval 2.24 to 4.14
2.72 fold rise
Interval 1.64 to 4.48
2.28 fold rise
Interval 1.57 to 3.31
1.92 fold rise
Interval 1.35 to 2.72
2.72 fold rise
Interval 1.73 to 4.29
2.17 fold rise
Interval 1.4 to 3.37
2.59 fold rise
Interval 1.74 to 3.85
2.34 fold rise
Interval 1.56 to 3.51
3.73 fold rise
Interval 1.99 to 7.01
2.53 fold rise
Interval 1.51 to 4.24
1.29 fold rise
Interval 1.05 to 1.59
1.34 fold rise
Interval 1.08 to 1.66
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in One Dose Groups.
Day 366
2.55 fold rise
Interval 1.9 to 3.43
2.45 fold rise
Interval 1.88 to 3.21
2.29 fold rise
Interval 1.76 to 2.96
1.96 fold rise
Interval 1.48 to 2.59
2.27 fold rise
Interval 1.67 to 3.09
2.45 fold rise
Interval 1.52 to 3.93
2.28 fold rise
Interval 1.49 to 3.48
1.82 fold rise
Interval 1.26 to 2.64
2.53 fold rise
Interval 1.6 to 3.99
2.59 fold rise
Interval 1.73 to 3.88
3.18 fold rise
Interval 1.96 to 5.16
1.88 fold rise
Interval 1.23 to 2.86
2.96 fold rise
Interval 1.68 to 5.23
2.44 fold rise
Interval 1.51 to 3.95
1.54 fold rise
Interval 1.22 to 1.95
1.61 fold rise
Interval 1.3 to 2.0
—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.
Day 15
6.72 fold rise
Interval 5.41 to 8.35
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.
Day 29
4.98 fold rise
Interval 4.01 to 6.19
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.
Day 57
4.15 fold rise
Interval 3.3 to 5.23
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.
Day 85
6.60 fold rise
Interval 5.17 to 8.42
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.
Day 147
3.32 fold rise
Interval 2.58 to 4.28
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.
Day 237
3.43 fold rise
Interval 2.52 to 4.66
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.
Day 327
2.61 fold rise
Interval 1.89 to 3.6
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against B.1.617.2 in Two Dose Group.
Day 422
2.64 fold rise
Interval 1.89 to 3.69
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.
Day 15
10.10 fold rise
Interval 7.93 to 12.85
16.85 fold rise
Interval 12.59 to 22.54
16.34 fold rise
Interval 12.2 to 21.89
17.50 fold rise
Interval 13.41 to 22.83
15.32 fold rise
Interval 11.57 to 20.29
5.93 fold rise
Interval 4.14 to 8.49
12.07 fold rise
Interval 8.5 to 17.13
14.51 fold rise
Interval 10.02 to 20.99
12.23 fold rise
Interval 8.47 to 17.65
9.37 fold rise
Interval 6.69 to 13.12
15.15 fold rise
Interval 9.61 to 23.89
2.98 fold rise
Interval 2.17 to 4.1
6.74 fold rise
Interval 4.12 to 11.03
4.28 fold rise
Interval 3.11 to 5.9
5.95 fold rise
Interval 4.86 to 7.28
6.49 fold rise
Interval 5.16 to 8.18
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.
Day 29
6.84 fold rise
Interval 5.38 to 8.69
12.75 fold rise
Interval 9.65 to 16.84
11.63 fold rise
Interval 8.59 to 15.76
12.07 fold rise
Interval 9.37 to 15.55
10.40 fold rise
Interval 8.03 to 13.47
3.81 fold rise
Interval 2.67 to 5.44
8.26 fold rise
Interval 5.82 to 11.71
11.70 fold rise
Interval 7.98 to 17.15
8.49 fold rise
Interval 6.04 to 11.92
7.07 fold rise
Interval 5.03 to 9.95
9.40 fold rise
Interval 6.04 to 14.63
2.59 fold rise
Interval 1.65 to 4.06
8.72 fold rise
Interval 4.95 to 15.36
4.94 fold rise
Interval 3.29 to 7.42
4.70 fold rise
Interval 3.9 to 5.65
5.10 fold rise
Interval 4.03 to 6.43
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.
Day 91
4.12 fold rise
Interval 3.05 to 5.56
8.18 fold rise
Interval 6.24 to 10.73
7.84 fold rise
Interval 5.8 to 10.61
6.94 fold rise
Interval 5.21 to 9.26
7.24 fold rise
Interval 5.41 to 9.7
3.02 fold rise
Interval 1.78 to 5.11
6.27 fold rise
Interval 4.07 to 9.67
9.44 fold rise
Interval 6.33 to 14.09
6.44 fold rise
Interval 4.22 to 9.83
5.15 fold rise
Interval 3.3 to 8.03
8.01 fold rise
Interval 4.86 to 13.2
3.02 fold rise
Interval 1.8 to 5.04
6.29 fold rise
Interval 3.82 to 10.35
3.91 fold rise
Interval 2.42 to 6.32
3.52 fold rise
Interval 2.86 to 4.32
4.02 fold rise
Interval 3.13 to 5.18
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.
Day 181
2.72 fold rise
Interval 1.93 to 3.83
5.23 fold rise
Interval 3.71 to 7.38
4.52 fold rise
Interval 3.17 to 6.44
4.84 fold rise
Interval 3.47 to 6.74
5.17 fold rise
Interval 3.7 to 7.23
4.08 fold rise
Interval 2.04 to 8.15
4.20 fold rise
Interval 2.36 to 7.46
5.32 fold rise
Interval 3.39 to 8.35
4.84 fold rise
Interval 3.0 to 7.81
3.66 fold rise
Interval 2.34 to 5.73
5.15 fold rise
Interval 2.89 to 9.17
4.58 fold rise
Interval 2.68 to 7.83
7.92 fold rise
Interval 4.51 to 13.9
6.17 fold rise
Interval 3.83 to 9.93
2.95 fold rise
Interval 2.28 to 3.8
3.23 fold rise
Interval 2.42 to 4.3
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.
Day 271
5.77 fold rise
Interval 4.01 to 8.28
8.21 fold rise
Interval 5.76 to 11.69
8.76 fold rise
Interval 5.96 to 12.87
7.40 fold rise
Interval 5.26 to 10.42
8.20 fold rise
Interval 5.73 to 11.75
6.42 fold rise
Interval 3.39 to 12.17
7.53 fold rise
Interval 4.89 to 11.6
6.14 fold rise
Interval 3.75 to 10.06
7.09 fold rise
Interval 4.23 to 11.88
5.54 fold rise
Interval 3.3 to 9.3
8.36 fold rise
Interval 4.74 to 14.75
6.35 fold rise
Interval 3.61 to 11.17
7.00 fold rise
Interval 3.96 to 12.38
6.26 fold rise
Interval 3.59 to 10.94
2.33 fold rise
Interval 1.79 to 3.02
2.33 fold rise
Interval 1.75 to 3.11
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in One Dose Groups.
Day 366
4.84 fold rise
Interval 3.34 to 7.02
7.30 fold rise
Interval 5.11 to 10.44
7.18 fold rise
Interval 4.92 to 10.48
5.94 fold rise
Interval 4.1 to 8.62
5.64 fold rise
Interval 3.93 to 8.1
4.75 fold rise
Interval 2.48 to 9.09
7.10 fold rise
Interval 4.32 to 11.69
6.36 fold rise
Interval 3.78 to 10.67
6.56 fold rise
Interval 3.89 to 11.08
6.67 fold rise
Interval 4.07 to 10.92
11.14 fold rise
Interval 6.02 to 20.61
5.13 fold rise
Interval 2.9 to 9.09
6.75 fold rise
Interval 4.06 to 11.2
5.86 fold rise
Interval 3.45 to 9.93
2.24 fold rise
Interval 1.69 to 2.98
2.09 fold rise
Interval 1.58 to 2.77
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.
Day 237
8.78 fold rise
Interval 6.13 to 12.58
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.
Day 327
8.29 fold rise
Interval 5.7 to 12.06
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.
Day 15
17.18 fold rise
Interval 13.24 to 22.28
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.
Day 29
12.96 fold rise
Interval 9.89 to 17.0
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.
Day 57
9.08 fold rise
Interval 6.98 to 11.79
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.
Day 85
16.67 fold rise
Interval 12.55 to 22.14
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.
Day 147
10.48 fold rise
Interval 7.92 to 13.87
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.1 in Two Dose Group.
Day 422
8.79 fold rise
Interval 5.89 to 13.12
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=25 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=25 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=25 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=25 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=25 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.2.12.1 in One Dose Groups.
10.84 fold rise
Interval 7.48 to 15.71
9.34 fold rise
Interval 5.48 to 15.92
11.84 fold rise
Interval 5.81 to 24.12
9.01 fold rise
Interval 5.38 to 15.1
8.65 fold rise
Interval 5.53 to 13.53
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.
Day 15
12.31 fold rise
Interval 8.59 to 17.65
10.06 fold rise
Interval 6.42 to 15.77
16.19 fold rise
Interval 7.86 to 33.36
9.20 fold rise
Interval 5.26 to 16.09
12.25 fold rise
Interval 6.83 to 21.97
—
—
—
8.45 fold rise
95% confidence interval was not estimable as data from only 1 participant was analyzed
—
—
3.10 fold rise
Interval 2.19 to 4.39
5.54 fold rise
Interval 3.64 to 8.44
4.37 fold rise
Interval 3.0 to 6.35
4.65 fold rise
Interval 3.76 to 5.77
8.04 fold rise
Interval 6.26 to 10.32
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.
Day 29
6.56 fold rise
Interval 5.11 to 8.42
10.34 fold rise
Interval 7.81 to 13.69
11.93 fold rise
Interval 8.98 to 15.84
8.45 fold rise
Interval 6.58 to 10.87
9.88 fold rise
Interval 7.45 to 13.11
4.21 fold rise
Interval 3.19 to 5.56
8.39 fold rise
Interval 5.88 to 11.98
9.51 fold rise
Interval 6.34 to 14.26
9.40 fold rise
Interval 6.76 to 13.07
9.72 fold rise
Interval 7.0 to 13.5
8.75 fold rise
Interval 5.73 to 13.37
3.68 fold rise
Interval 2.63 to 5.15
6.57 fold rise
Interval 4.15 to 10.41
5.46 fold rise
Interval 3.59 to 8.31
4.03 fold rise
Interval 3.25 to 5.0
6.64 fold rise
Interval 5.26 to 8.37
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.
Day 91
4.82 fold rise
Interval 3.48 to 6.67
8.98 fold rise
Interval 6.8 to 11.88
8.63 fold rise
Interval 6.31 to 11.81
6.64 fold rise
Interval 4.96 to 8.89
8.01 fold rise
Interval 5.8 to 11.08
3.96 fold rise
Interval 2.41 to 6.52
6.96 fold rise
Interval 4.54 to 10.67
6.65 fold rise
Interval 4.17 to 10.6
6.49 fold rise
Interval 4.22 to 9.97
6.55 fold rise
Interval 4.16 to 10.3
7.07 fold rise
Interval 4.28 to 11.67
3.22 fold rise
Interval 1.76 to 5.9
6.41 fold rise
Interval 3.73 to 11.02
4.81 fold rise
Interval 2.92 to 7.93
2.77 fold rise
Interval 2.17 to 3.54
5.27 fold rise
Interval 4.09 to 6.77
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.
Day 181
3.36 fold rise
Interval 2.31 to 4.88
6.08 fold rise
Interval 4.15 to 8.89
5.21 fold rise
Interval 3.58 to 7.58
5.29 fold rise
Interval 3.64 to 7.67
6.83 fold rise
Interval 4.57 to 10.21
5.80 fold rise
Interval 2.86 to 11.76
4.84 fold rise
Interval 2.88 to 8.15
4.92 fold rise
Interval 2.9 to 8.34
5.92 fold rise
Interval 3.65 to 9.62
5.07 fold rise
Interval 3.05 to 8.43
5.85 fold rise
Interval 3.25 to 10.53
5.39 fold rise
Interval 2.9 to 10.03
8.48 fold rise
Interval 4.54 to 15.84
6.86 fold rise
Interval 3.91 to 12.03
2.71 fold rise
Interval 2.04 to 3.6
4.34 fold rise
Interval 3.23 to 5.85
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.
Day 271
8.95 fold rise
Interval 6.1 to 13.13
11.67 fold rise
Interval 7.88 to 17.28
11.05 fold rise
Interval 7.58 to 16.12
9.92 fold rise
Interval 6.84 to 14.38
12.73 fold rise
Interval 8.47 to 19.13
10.41 fold rise
Interval 5.46 to 19.86
10.18 fold rise
Interval 6.23 to 16.62
7.00 fold rise
Interval 4.24 to 11.56
11.20 fold rise
Interval 6.32 to 19.82
9.77 fold rise
Interval 5.59 to 17.07
9.69 fold rise
Interval 5.4 to 17.37
8.60 fold rise
Interval 4.48 to 16.51
8.79 fold rise
Interval 4.94 to 15.66
8.53 fold rise
Interval 4.79 to 15.19
2.31 fold rise
Interval 1.67 to 3.18
3.24 fold rise
Interval 2.39 to 4.39
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in One Dose Groups.
Day 366
8.16 fold rise
Interval 5.6 to 11.9
10.49 fold rise
Interval 7.04 to 15.63
10.03 fold rise
Interval 6.87 to 14.64
8.47 fold rise
Interval 5.71 to 12.57
8.58 fold rise
Interval 5.75 to 12.79
10.05 fold rise
Interval 5.31 to 19.01
9.73 fold rise
Interval 5.7 to 16.61
6.70 fold rise
Interval 3.91 to 11.51
10.95 fold rise
Interval 6.04 to 19.86
13.41 fold rise
Interval 7.87 to 22.85
13.61 fold rise
Interval 7.24 to 25.58
7.36 fold rise
Interval 3.8 to 14.24
9.19 fold rise
Interval 5.23 to 16.16
8.73 fold rise
Interval 4.95 to 15.41
2.35 fold rise
Interval 1.68 to 3.28
2.88 fold rise
Interval 2.15 to 3.87
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.
Day 15
40.80 fold rise
95% confidence interval is not estimable as data from only 1 participant was analyzed.
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.
Day 29
10.61 fold rise
Interval 8.04 to 14.0
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.
Day 57
8.51 fold rise
Interval 6.48 to 11.16
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.
Day 85
15.55 fold rise
Interval 11.7 to 20.67
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.
Day 147
9.05 fold rise
Interval 6.56 to 12.48
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.
Day 237
11.11 fold rise
Interval 7.57 to 16.3
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.
Day 327
11.06 fold rise
Interval 7.23 to 16.92
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Fold Rise (GMFR) of Pseudovirus Neutralization From Baseline Antibody Against BA.4/BA.5 in Two Dose Group.
Day 422
11.68 fold rise
Interval 7.52 to 18.14
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=98 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.
Day 271
390584.35 Arbitrary Units*1/Dilution
Interval 325688.98 to 468410.5
431882.28 Arbitrary Units*1/Dilution
Interval 367242.99 to 507898.89
452851.99 Arbitrary Units*1/Dilution
Interval 382444.94 to 536220.79
475740.12 Arbitrary Units*1/Dilution
Interval 400055.36 to 565743.35
466559.85 Arbitrary Units*1/Dilution
Interval 387663.08 to 561513.61
580706.90 Arbitrary Units*1/Dilution
Interval 476686.95 to 707425.5
346700.48 Arbitrary Units*1/Dilution
Interval 276953.35 to 434012.52
301421.05 Arbitrary Units*1/Dilution
Interval 218160.68 to 416457.49
394254.66 Arbitrary Units*1/Dilution
Interval 298422.8 to 520860.8
421371.41 Arbitrary Units*1/Dilution
Interval 321087.78 to 552976.09
383558.51 Arbitrary Units*1/Dilution
Interval 285466.37 to 515357.13
442185.42 Arbitrary Units*1/Dilution
Interval 342582.32 to 570747.33
414729.20 Arbitrary Units*1/Dilution
Interval 300599.23 to 572191.43
394141.46 Arbitrary Units*1/Dilution
Interval 291957.9 to 532088.67
271252.94 Arbitrary Units*1/Dilution
Interval 226888.75 to 324291.8
286565.58 Arbitrary Units*1/Dilution
Interval 245217.19 to 334886.11
—
Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.
Day 29
643473.03 Arbitrary Units*1/Dilution
Interval 560692.1 to 738475.79
733522.42 Arbitrary Units*1/Dilution
Interval 649743.77 to 828103.58
751245.45 Arbitrary Units*1/Dilution
Interval 648796.71 to 869871.45
727260.22 Arbitrary Units*1/Dilution
Interval 643219.99 to 822280.77
732226.74 Arbitrary Units*1/Dilution
Interval 644366.79 to 832066.46
659275.24 Arbitrary Units*1/Dilution
Interval 548924.63 to 791809.69
657238.13 Arbitrary Units*1/Dilution
Interval 555813.86 to 777170.18
552682.55 Arbitrary Units*1/Dilution
Interval 442382.31 to 690484.22
668859.02 Arbitrary Units*1/Dilution
Interval 547609.32 to 816955.38
780465.85 Arbitrary Units*1/Dilution
Interval 642036.37 to 948742.12
828997.70 Arbitrary Units*1/Dilution
Interval 702454.95 to 978336.31
480315.31 Arbitrary Units*1/Dilution
Interval 397529.55 to 580341.26
495494.62 Arbitrary Units*1/Dilution
Interval 384679.35 to 638232.65
494440.20 Arbitrary Units*1/Dilution
Interval 388582.83 to 629135.12
626852.32 Arbitrary Units*1/Dilution
Interval 549349.76 to 715288.98
751965.51 Arbitrary Units*1/Dilution
Interval 666099.41 to 848900.5
—
Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.
Day 1
160130.96 Arbitrary Units*1/Dilution
Interval 129306.07 to 198304.11
207723.16 Arbitrary Units*1/Dilution
Interval 175454.95 to 245925.88
202202.73 Arbitrary Units*1/Dilution
Interval 166561.76 to 245470.18
196631.40 Arbitrary Units*1/Dilution
Interval 163415.98 to 236598.09
212964.59 Arbitrary Units*1/Dilution
Interval 175702.33 to 258129.29
235396.11 Arbitrary Units*1/Dilution
Interval 173485.95 to 319399.5
182053.56 Arbitrary Units*1/Dilution
Interval 142739.02 to 232196.48
170171.30 Arbitrary Units*1/Dilution
Interval 126165.92 to 229525.31
165049.51 Arbitrary Units*1/Dilution
Interval 123533.92 to 220517.08
187732.35 Arbitrary Units*1/Dilution
Interval 147721.17 to 238580.79
225024.80 Arbitrary Units*1/Dilution
Interval 172975.49 to 292736.06
232208.85 Arbitrary Units*1/Dilution
Interval 174691.62 to 308663.64
207078.95 Arbitrary Units*1/Dilution
Interval 151240.53 to 283533.07
223811.30 Arbitrary Units*1/Dilution
Interval 162517.09 to 308222.95
216940.66 Arbitrary Units*1/Dilution
Interval 179276.43 to 262517.77
227685.26 Arbitrary Units*1/Dilution
Interval 191148.7 to 271205.49
—
Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.
Day 91
438337.91 Arbitrary Units*1/Dilution
Interval 378653.5 to 507429.94
491732.55 Arbitrary Units*1/Dilution
Interval 427405.36 to 565741.4
514596.59 Arbitrary Units*1/Dilution
Interval 432927.07 to 611672.65
500148.94 Arbitrary Units*1/Dilution
Interval 442720.16 to 565027.27
536531.50 Arbitrary Units*1/Dilution
Interval 457973.81 to 628564.44
548300.07 Arbitrary Units*1/Dilution
Interval 447722.91 to 671471.03
461530.27 Arbitrary Units*1/Dilution
Interval 376981.71 to 565041.19
391247.40 Arbitrary Units*1/Dilution
Interval 303480.78 to 504396.12
448950.77 Arbitrary Units*1/Dilution
Interval 358372.82 to 562422.1
514233.46 Arbitrary Units*1/Dilution
Interval 410998.8 to 643398.59
556630.53 Arbitrary Units*1/Dilution
Interval 454565.36 to 681612.76
398264.81 Arbitrary Units*1/Dilution
Interval 307117.53 to 516463.06
428565.45 Arbitrary Units*1/Dilution
Interval 340090.46 to 540057.33
438037.58 Arbitrary Units*1/Dilution
Interval 339081.21 to 565873.06
442103.46 Arbitrary Units*1/Dilution
Interval 380985.37 to 513026.18
510417.03 Arbitrary Units*1/Dilution
Interval 444881.85 to 585606.14
—
Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.
Day 181
298887.11 Arbitrary Units*1/Dilution
Interval 250797.08 to 356198.34
353554.44 Arbitrary Units*1/Dilution
Interval 296724.8 to 421268.26
347652.35 Arbitrary Units*1/Dilution
Interval 284713.04 to 424505.16
367923.35 Arbitrary Units*1/Dilution
Interval 314484.84 to 430442.34
395234.07 Arbitrary Units*1/Dilution
Interval 332468.37 to 469849.11
478836.67 Arbitrary Units*1/Dilution
Interval 391278.37 to 585988.34
294887.23 Arbitrary Units*1/Dilution
Interval 235836.33 to 368723.86
301817.71 Arbitrary Units*1/Dilution
Interval 221380.26 to 411481.73
320772.07 Arbitrary Units*1/Dilution
Interval 252468.56 to 407554.59
385153.46 Arbitrary Units*1/Dilution
Interval 301669.57 to 491740.64
334355.35 Arbitrary Units*1/Dilution
Interval 259649.52 to 430555.39
417943.47 Arbitrary Units*1/Dilution
Interval 312516.72 to 558935.67
396620.26 Arbitrary Units*1/Dilution
Interval 299395.4 to 525417.65
394207.59 Arbitrary Units*1/Dilution
Interval 304879.45 to 509708.42
324842.08 Arbitrary Units*1/Dilution
Interval 277309.16 to 380522.5
383432.41 Arbitrary Units*1/Dilution
Interval 332019.9 to 442806.03
—
Geometric Mean (GM) AUC of Antibody Against Wa-1 in One Dose Groups.
Day 366
310610.18 Arbitrary Units*1/Dilution
Interval 258096.07 to 373809.19
372637.70 Arbitrary Units*1/Dilution
Interval 315316.19 to 440379.71
377586.71 Arbitrary Units*1/Dilution
Interval 314604.53 to 453177.59
350750.36 Arbitrary Units*1/Dilution
Interval 298128.48 to 412660.4
357990.63 Arbitrary Units*1/Dilution
Interval 302163.02 to 424132.93
345763.94 Arbitrary Units*1/Dilution
Interval 280205.28 to 426661.14
266067.35 Arbitrary Units*1/Dilution
Interval 214976.08 to 329301.0
231315.61 Arbitrary Units*1/Dilution
Interval 169652.11 to 315391.95
272137.87 Arbitrary Units*1/Dilution
Interval 204275.55 to 362544.7
332233.81 Arbitrary Units*1/Dilution
Interval 255504.78 to 432004.84
303821.76 Arbitrary Units*1/Dilution
Interval 226449.66 to 407629.93
319747.17 Arbitrary Units*1/Dilution
Interval 243868.05 to 419235.93
281475.15 Arbitrary Units*1/Dilution
Interval 206656.68 to 383381.07
301625.72 Arbitrary Units*1/Dilution
Interval 225119.59 to 404132.2
239959.56 Arbitrary Units*1/Dilution
Interval 201762.03 to 285388.63
242634.48 Arbitrary Units*1/Dilution
Interval 207407.3 to 283844.85
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.
Day 1
170503.26 Arbitrary Units*1/Dilution
Interval 137457.73 to 211493.11
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.
Day 29
606554.56 Arbitrary Units*1/Dilution
Interval 517874.98 to 710419.4
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.
Day 57
494683.51 Arbitrary Units*1/Dilution
Interval 420526.83 to 581917.14
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.
Day 85
762319.06 Arbitrary Units*1/Dilution
Interval 664514.22 to 874519.05
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.
Day 147
582298.62 Arbitrary Units*1/Dilution
Interval 491139.17 to 690378.01
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.
Day 237
447713.57 Arbitrary Units*1/Dilution
Interval 368540.63 to 543895.11
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.
Day 327
395463.67 Arbitrary Units*1/Dilution
Interval 327719.15 to 477212.02
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against Wa-1 in Two Dose Group.
Day 422
302772.82 Arbitrary Units*1/Dilution
Interval 249170.24 to 367906.61
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.
Day 1
93551.19 Arbitrary Units*1/Dilution
Interval 75078.9 to 116568.38
129906.22 Arbitrary Units*1/Dilution
Interval 109275.29 to 154432.23
116649.05 Arbitrary Units*1/Dilution
Interval 95341.67 to 142718.31
115206.13 Arbitrary Units*1/Dilution
Interval 95211.58 to 139399.56
128531.47 Arbitrary Units*1/Dilution
Interval 104670.04 to 157832.56
135763.15 Arbitrary Units*1/Dilution
Interval 99440.49 to 185353.4
104424.42 Arbitrary Units*1/Dilution
Interval 80261.61 to 135861.47
110265.46 Arbitrary Units*1/Dilution
Interval 80618.46 to 150814.99
100277.89 Arbitrary Units*1/Dilution
Interval 74167.67 to 135580.02
121192.68 Arbitrary Units*1/Dilution
Interval 91029.66 to 161350.31
135028.37 Arbitrary Units*1/Dilution
Interval 102158.31 to 178474.58
150238.68 Arbitrary Units*1/Dilution
Interval 108957.54 to 207160.17
134064.73 Arbitrary Units*1/Dilution
Interval 95854.88 to 187505.86
139963.38 Arbitrary Units*1/Dilution
Interval 100342.92 to 195227.99
136025.14 Arbitrary Units*1/Dilution
Interval 111826.03 to 165460.93
144727.88 Arbitrary Units*1/Dilution
Interval 120097.52 to 174409.6
—
Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.
Day 29
436540.44 Arbitrary Units*1/Dilution
Interval 376880.27 to 505644.81
536040.87 Arbitrary Units*1/Dilution
Interval 474391.87 to 605701.39
497454.13 Arbitrary Units*1/Dilution
Interval 424663.31 to 582721.91
522838.44 Arbitrary Units*1/Dilution
Interval 461094.9 to 592849.84
510066.75 Arbitrary Units*1/Dilution
Interval 439438.66 to 592046.44
468813.37 Arbitrary Units*1/Dilution
Interval 381774.62 to 575695.62
499652.43 Arbitrary Units*1/Dilution
Interval 416521.98 to 599374.26
441732.81 Arbitrary Units*1/Dilution
Interval 352523.1 to 553517.97
536875.49 Arbitrary Units*1/Dilution
Interval 434894.96 to 662769.91
535912.15 Arbitrary Units*1/Dilution
Interval 434670.77 to 660734.18
590251.89 Arbitrary Units*1/Dilution
Interval 493880.47 to 705428.37
327932.05 Arbitrary Units*1/Dilution
Interval 263367.44 to 408324.69
386837.28 Arbitrary Units*1/Dilution
Interval 294054.43 to 508895.86
359000.12 Arbitrary Units*1/Dilution
Interval 276299.54 to 466454.22
479928.00 Arbitrary Units*1/Dilution
Interval 418836.28 to 549930.61
547431.70 Arbitrary Units*1/Dilution
Interval 482946.41 to 620527.36
—
Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.
Day 91
260600.97 Arbitrary Units*1/Dilution
Interval 224396.48 to 302646.74
353154.19 Arbitrary Units*1/Dilution
Interval 307127.09 to 406079.06
337018.67 Arbitrary Units*1/Dilution
Interval 279601.8 to 406226.21
368777.24 Arbitrary Units*1/Dilution
Interval 323248.64 to 420718.39
364466.11 Arbitrary Units*1/Dilution
Interval 307829.74 to 431522.78
343409.80 Arbitrary Units*1/Dilution
Interval 275950.45 to 427360.39
339016.33 Arbitrary Units*1/Dilution
Interval 274108.66 to 419293.84
304500.86 Arbitrary Units*1/Dilution
Interval 233667.5 to 396806.47
358322.49 Arbitrary Units*1/Dilution
Interval 282483.03 to 454522.9
395543.34 Arbitrary Units*1/Dilution
Interval 310803.13 to 503387.91
396620.95 Arbitrary Units*1/Dilution
Interval 318981.99 to 493156.94
264515.83 Arbitrary Units*1/Dilution
Interval 200295.28 to 349327.37
315462.53 Arbitrary Units*1/Dilution
Interval 244506.65 to 407009.83
296474.19 Arbitrary Units*1/Dilution
Interval 226058.64 to 388823.64
307530.83 Arbitrary Units*1/Dilution
Interval 262787.72 to 359892.04
360330.74 Arbitrary Units*1/Dilution
Interval 312470.31 to 415521.85
—
Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.
Day 181
173909.68 Arbitrary Units*1/Dilution
Interval 143380.99 to 210938.54
237513.05 Arbitrary Units*1/Dilution
Interval 199090.53 to 283350.74
228919.38 Arbitrary Units*1/Dilution
Interval 183497.82 to 285584.22
238062.10 Arbitrary Units*1/Dilution
Interval 203710.45 to 278206.46
258839.20 Arbitrary Units*1/Dilution
Interval 214625.36 to 312161.32
303657.19 Arbitrary Units*1/Dilution
Interval 245914.64 to 374958.11
192668.11 Arbitrary Units*1/Dilution
Interval 150365.03 to 246872.57
219015.58 Arbitrary Units*1/Dilution
Interval 159282.21 to 301149.93
245072.17 Arbitrary Units*1/Dilution
Interval 187309.29 to 320648.11
263281.28 Arbitrary Units*1/Dilution
Interval 201601.41 to 343832.08
234800.63 Arbitrary Units*1/Dilution
Interval 178900.06 to 308168.36
275654.28 Arbitrary Units*1/Dilution
Interval 204726.77 to 371154.58
300882.56 Arbitrary Units*1/Dilution
Interval 221725.62 to 408298.85
287091.71 Arbitrary Units*1/Dilution
Interval 217849.16 to 378342.73
235298.55 Arbitrary Units*1/Dilution
Interval 198020.37 to 279594.51
280572.85 Arbitrary Units*1/Dilution
Interval 240451.74 to 327388.45
—
Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.
Day 271
258643.48 Arbitrary Units*1/Dilution
Interval 212437.89 to 314898.85
328407.16 Arbitrary Units*1/Dilution
Interval 276854.0 to 389560.08
331083.82 Arbitrary Units*1/Dilution
Interval 275761.38 to 397504.89
336408.76 Arbitrary Units*1/Dilution
Interval 281631.43 to 401840.29
338933.50 Arbitrary Units*1/Dilution
Interval 278671.06 to 412227.66
408169.15 Arbitrary Units*1/Dilution
Interval 330873.4 to 503522.05
242648.32 Arbitrary Units*1/Dilution
Interval 188718.4 to 311989.76
222230.23 Arbitrary Units*1/Dilution
Interval 160616.45 to 307479.57
294022.31 Arbitrary Units*1/Dilution
Interval 219359.96 to 394097.09
311998.19 Arbitrary Units*1/Dilution
Interval 231177.8 to 421073.61
284552.50 Arbitrary Units*1/Dilution
Interval 209437.76 to 386607.11
315964.73 Arbitrary Units*1/Dilution
Interval 242926.24 to 410963.04
312951.39 Arbitrary Units*1/Dilution
Interval 222960.86 to 439263.5
300475.72 Arbitrary Units*1/Dilution
Interval 217340.28 to 415411.53
190613.29 Arbitrary Units*1/Dilution
Interval 157623.37 to 230507.85
199914.23 Arbitrary Units*1/Dilution
Interval 169853.36 to 235295.3
—
Geometric Mean (GM) AUC of Antibody Against B.1.351 in One Dose Groups.
Day 366
221467.29 Arbitrary Units*1/Dilution
Interval 180356.7 to 271948.65
288113.03 Arbitrary Units*1/Dilution
Interval 239895.57 to 346021.9
267894.35 Arbitrary Units*1/Dilution
Interval 219924.61 to 326327.2
249713.10 Arbitrary Units*1/Dilution
Interval 209280.07 to 297957.82
247236.94 Arbitrary Units*1/Dilution
Interval 206166.46 to 296489.08
243160.36 Arbitrary Units*1/Dilution
Interval 192000.49 to 307952.15
181309.72 Arbitrary Units*1/Dilution
Interval 143792.2 to 228616.12
156958.86 Arbitrary Units*1/Dilution
Interval 116124.63 to 212152.1
200084.98 Arbitrary Units*1/Dilution
Interval 148201.09 to 270132.95
253664.70 Arbitrary Units*1/Dilution
Interval 187302.66 to 343539.07
231244.70 Arbitrary Units*1/Dilution
Interval 170470.44 to 313685.55
227063.40 Arbitrary Units*1/Dilution
Interval 167501.42 to 307805.08
216318.74 Arbitrary Units*1/Dilution
Interval 154124.59 to 303610.19
215517.27 Arbitrary Units*1/Dilution
Interval 158858.38 to 292384.3
164587.63 Arbitrary Units*1/Dilution
Interval 136637.76 to 198254.78
163821.61 Arbitrary Units*1/Dilution
Interval 139478.93 to 192412.7
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.
Day 1
99752.03 Arbitrary Units*1/Dilution
Interval 79297.68 to 125482.45
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.
Day 29
467456.52 Arbitrary Units*1/Dilution
Interval 396238.18 to 551475.38
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.
Day 57
383162.27 Arbitrary Units*1/Dilution
Interval 321719.82 to 456339.08
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.
Day 85
601632.71 Arbitrary Units*1/Dilution
Interval 518559.18 to 698014.67
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.
Day 147
440762.25 Arbitrary Units*1/Dilution
Interval 368674.52 to 526945.44
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.
Day 237
339450.17 Arbitrary Units*1/Dilution
Interval 277014.51 to 415958.07
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.
Day 327
290896.60 Arbitrary Units*1/Dilution
Interval 238344.4 to 355035.95
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against B.1.351 in Two Dose Group.
Day 422
217113.45 Arbitrary Units*1/Dilution
Interval 176796.73 to 266623.98
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.
Day 181
67934.34 Arbitrary Units*1/Dilution
Interval 55305.96 to 83446.24
95644.75 Arbitrary Units*1/Dilution
Interval 79114.54 to 115628.79
89619.90 Arbitrary Units*1/Dilution
Interval 70683.74 to 113629.07
96998.27 Arbitrary Units*1/Dilution
Interval 81579.63 to 115331.05
103752.38 Arbitrary Units*1/Dilution
Interval 85159.85 to 126404.14
117299.54 Arbitrary Units*1/Dilution
Interval 92895.44 to 148114.72
78601.03 Arbitrary Units*1/Dilution
Interval 59970.15 to 103019.95
96217.34 Arbitrary Units*1/Dilution
Interval 68381.48 to 135384.29
88377.85 Arbitrary Units*1/Dilution
Interval 67626.56 to 115496.69
100149.77 Arbitrary Units*1/Dilution
Interval 76233.87 to 131568.49
108679.49 Arbitrary Units*1/Dilution
Interval 78803.64 to 149881.79
106506.21 Arbitrary Units*1/Dilution
Interval 77882.34 to 145650.13
122787.89 Arbitrary Units*1/Dilution
Interval 84823.97 to 177742.99
107521.40 Arbitrary Units*1/Dilution
Interval 78962.21 to 146409.93
93570.97 Arbitrary Units*1/Dilution
Interval 77636.77 to 112775.52
102367.44 Arbitrary Units*1/Dilution
Interval 86226.19 to 121530.27
—
Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.
Day 1
35858.62 Arbitrary Units*1/Dilution
Interval 28544.5 to 45046.88
50667.27 Arbitrary Units*1/Dilution
Interval 41821.05 to 61384.7
46101.27 Arbitrary Units*1/Dilution
Interval 36611.11 to 58051.43
43880.60 Arbitrary Units*1/Dilution
Interval 35811.7 to 53767.55
48636.02 Arbitrary Units*1/Dilution
Interval 39357.99 to 60101.2
53148.74 Arbitrary Units*1/Dilution
Interval 38023.65 to 74290.3
37332.20 Arbitrary Units*1/Dilution
Interval 28270.98 to 49297.67
39668.84 Arbitrary Units*1/Dilution
Interval 28557.73 to 55103.0
36466.06 Arbitrary Units*1/Dilution
Interval 26603.75 to 49984.44
46523.96 Arbitrary Units*1/Dilution
Interval 34272.24 to 63155.46
56154.79 Arbitrary Units*1/Dilution
Interval 40714.86 to 77449.85
55708.69 Arbitrary Units*1/Dilution
Interval 39647.52 to 78276.23
51579.87 Arbitrary Units*1/Dilution
Interval 35935.37 to 74035.22
53338.07 Arbitrary Units*1/Dilution
Interval 37253.33 to 76367.68
48508.52 Arbitrary Units*1/Dilution
Interval 39245.75 to 59957.49
50242.30 Arbitrary Units*1/Dilution
Interval 41180.19 to 61298.62
—
Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.
Day 29
191702.35 Arbitrary Units*1/Dilution
Interval 164106.87 to 223938.16
245795.04 Arbitrary Units*1/Dilution
Interval 214464.11 to 281703.09
243857.48 Arbitrary Units*1/Dilution
Interval 202010.59 to 294373.04
268727.94 Arbitrary Units*1/Dilution
Interval 229848.03 to 314184.58
245471.75 Arbitrary Units*1/Dilution
Interval 209505.23 to 287612.76
199576.30 Arbitrary Units*1/Dilution
Interval 159461.92 to 249781.88
228987.60 Arbitrary Units*1/Dilution
Interval 183030.45 to 286484.14
216259.20 Arbitrary Units*1/Dilution
Interval 166594.92 to 280729.1
215235.97 Arbitrary Units*1/Dilution
Interval 171659.19 to 269874.99
253784.67 Arbitrary Units*1/Dilution
Interval 197499.84 to 326109.93
343044.44 Arbitrary Units*1/Dilution
Interval 271270.81 to 433808.14
140177.75 Arbitrary Units*1/Dilution
Interval 111549.63 to 176153.01
168689.34 Arbitrary Units*1/Dilution
Interval 122859.78 to 231614.39
152376.48 Arbitrary Units*1/Dilution
Interval 113422.48 to 204708.92
219690.36 Arbitrary Units*1/Dilution
Interval 188573.15 to 255942.36
242501.72 Arbitrary Units*1/Dilution
Interval 208975.92 to 281406.04
—
Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.
Day 271
99192.03 Arbitrary Units*1/Dilution
Interval 80277.18 to 122563.58
131888.79 Arbitrary Units*1/Dilution
Interval 109150.1 to 159364.5
139325.91 Arbitrary Units*1/Dilution
Interval 113298.48 to 171332.48
139410.13 Arbitrary Units*1/Dilution
Interval 114786.42 to 169316.06
139473.50 Arbitrary Units*1/Dilution
Interval 112336.1 to 173166.57
149877.01 Arbitrary Units*1/Dilution
Interval 120234.22 to 186827.99
95340.03 Arbitrary Units*1/Dilution
Interval 72516.76 to 125346.49
92710.85 Arbitrary Units*1/Dilution
Interval 66119.63 to 129996.2
112221.17 Arbitrary Units*1/Dilution
Interval 81586.64 to 154358.5
122393.65 Arbitrary Units*1/Dilution
Interval 89820.97 to 166778.48
122432.06 Arbitrary Units*1/Dilution
Interval 87816.74 to 170691.93
127066.31 Arbitrary Units*1/Dilution
Interval 95295.52 to 169429.24
120389.82 Arbitrary Units*1/Dilution
Interval 82167.3 to 176392.65
117354.27 Arbitrary Units*1/Dilution
Interval 81343.6 to 169306.81
70720.41 Arbitrary Units*1/Dilution
Interval 56789.58 to 88068.56
66434.87 Arbitrary Units*1/Dilution
Interval 55341.74 to 79751.6
—
Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.
Day 91
111776.32 Arbitrary Units*1/Dilution
Interval 94301.82 to 132488.92
150303.44 Arbitrary Units*1/Dilution
Interval 128509.07 to 175794.0
154578.88 Arbitrary Units*1/Dilution
Interval 124948.41 to 191235.97
168167.22 Arbitrary Units*1/Dilution
Interval 144346.78 to 195918.55
163330.96 Arbitrary Units*1/Dilution
Interval 134898.13 to 197756.65
130887.24 Arbitrary Units*1/Dilution
Interval 104132.56 to 164515.98
131524.99 Arbitrary Units*1/Dilution
Interval 104482.91 to 165566.05
138870.07 Arbitrary Units*1/Dilution
Interval 102534.27 to 188082.45
142416.99 Arbitrary Units*1/Dilution
Interval 108517.33 to 186906.53
165935.22 Arbitrary Units*1/Dilution
Interval 126207.83 to 218167.89
174816.63 Arbitrary Units*1/Dilution
Interval 138986.83 to 219883.08
108504.45 Arbitrary Units*1/Dilution
Interval 80492.5 to 146264.74
119334.36 Arbitrary Units*1/Dilution
Interval 90217.56 to 157848.32
110503.80 Arbitrary Units*1/Dilution
Interval 83053.87 to 147026.12
131000.91 Arbitrary Units*1/Dilution
Interval 110029.5 to 155969.42
140386.22 Arbitrary Units*1/Dilution
Interval 119592.54 to 164795.31
—
Geometric Mean (GM) AUC of Antibody Against BA.1 in One Dose Groups.
Day 366
79561.28 Arbitrary Units*1/Dilution
Interval 63948.44 to 98985.96
105460.05 Arbitrary Units*1/Dilution
Interval 86839.37 to 128073.5
106503.48 Arbitrary Units*1/Dilution
Interval 85253.96 to 133049.43
99354.35 Arbitrary Units*1/Dilution
Interval 81713.17 to 120804.13
92964.28 Arbitrary Units*1/Dilution
Interval 76395.58 to 113126.41
85243.80 Arbitrary Units*1/Dilution
Interval 66428.02 to 109389.15
67777.11 Arbitrary Units*1/Dilution
Interval 52510.16 to 87482.81
63755.85 Arbitrary Units*1/Dilution
Interval 45948.96 to 88463.56
78292.70 Arbitrary Units*1/Dilution
Interval 55674.78 to 110099.19
95692.23 Arbitrary Units*1/Dilution
Interval 69900.64 to 131000.28
97653.95 Arbitrary Units*1/Dilution
Interval 69113.3 to 137980.58
78559.42 Arbitrary Units*1/Dilution
Interval 57473.61 to 107381.14
70561.84 Arbitrary Units*1/Dilution
Interval 48140.57 to 103425.72
76460.37 Arbitrary Units*1/Dilution
Interval 54315.81 to 107633.26
61045.92 Arbitrary Units*1/Dilution
Interval 49522.11 to 75251.32
54849.37 Arbitrary Units*1/Dilution
Interval 45941.98 to 65483.76
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.
Day 57
184155.65 Arbitrary Units*1/Dilution
Interval 150366.02 to 225538.33
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.
Day 1
39029.80 Arbitrary Units*1/Dilution
Interval 30219.86 to 50408.08
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.
Day 29
232195.94 Arbitrary Units*1/Dilution
Interval 191647.37 to 281323.74
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.
Day 85
303406.48 Arbitrary Units*1/Dilution
Interval 255832.11 to 359827.76
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.
Day 147
206168.23 Arbitrary Units*1/Dilution
Interval 167818.87 to 253281.06
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.
Day 237
132219.79 Arbitrary Units*1/Dilution
Interval 106176.3 to 164651.37
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.
Day 327
112933.35 Arbitrary Units*1/Dilution
Interval 91545.0 to 139318.83
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) AUC of Antibody Against BA.1 in Two Dose Group.
Day 422
79707.84 Arbitrary Units*1/Dilution
Interval 63831.66 to 99532.74
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.
Day 1
3245.3 titer
Interval 2437.1 to 4321.7
3959.5 titer
Interval 3011.8 to 5205.5
3537.5 titer
Interval 2621.4 to 4773.8
3874.1 titer
Interval 2930.3 to 5121.8
3595.9 titer
Interval 2603.1 to 4967.3
4761.5 titer
Interval 3136.8 to 7227.9
3720.3 titer
Interval 2462.4 to 5620.8
3982.2 titer
Interval 2757.9 to 5750.0
3687.5 titer
Interval 2246.9 to 6051.6
4423.3 titer
Interval 3121.8 to 6267.3
4686.6 titer
Interval 3120.4 to 7039.0
5196.7 titer
Interval 3499.0 to 7718.1
3432.5 titer
Interval 1970.0 to 5980.5
5419.9 titer
Interval 3586.6 to 8190.4
7448.8 titer
Interval 5944.6 to 9333.5
7786.8 titer
Interval 6056.9 to 10010.7
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.
Day 15
21060.3 titer
Interval 17431.9 to 25443.9
21523.4 titer
Interval 17685.7 to 26194.0
24323.2 titer
Interval 19090.6 to 30989.9
19304.9 titer
Interval 16023.6 to 23258.2
26279.7 titer
Interval 21858.1 to 31595.7
21566.8 titer
Interval 16564.3 to 28080.0
14986.8 titer
Interval 10502.8 to 21385.1
15842.2 titer
Interval 11653.3 to 21536.8
18854.6 titer
Interval 13408.9 to 26512.1
22458.9 titer
Interval 17223.2 to 29286.4
28322.2 titer
Interval 21912.1 to 36607.4
8102.7 titer
Interval 5946.9 to 11040.1
9670.5 titer
Interval 7151.0 to 13077.7
9982.9 titer
Interval 7470.3 to 13340.7
27493.0 titer
Interval 23775.4 to 31791.9
33715.5 titer
Interval 29188.9 to 38944.1
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.
Day 29
15972.1 titer
Interval 13059.2 to 19534.7
16815.7 titer
Interval 13977.3 to 20230.6
18250.6 titer
Interval 14438.1 to 23069.8
14380.9 titer
Interval 11875.8 to 17414.4
17680.2 titer
Interval 13979.4 to 22360.7
16440.9 titer
Interval 12881.8 to 20983.4
15825.6 titer
Interval 12730.1 to 19673.9
15451.6 titer
Interval 11369.0 to 21000.3
15674.6 titer
Interval 11193.5 to 21949.7
19718.1 titer
Interval 14861.3 to 26162.3
24139.0 titer
Interval 18398.1 to 31671.2
10390.1 titer
Interval 7637.2 to 14135.4
13898.2 titer
Interval 9838.0 to 19634.0
14825.3 titer
Interval 10909.1 to 20147.4
31502.1 titer
Interval 26665.9 to 37215.4
36372.7 titer
Interval 30960.4 to 42731.2
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.
Day 91
11701.1 titer
Interval 8786.7 to 15582.2
14410.2 titer
Interval 11561.7 to 17960.4
16558.4 titer
Interval 12500.4 to 21933.6
14296.6 titer
Interval 11443.9 to 17860.4
16567.5 titer
Interval 13410.8 to 20467.1
8878.3 titer
Interval 6899.7 to 11424.3
7168.4 titer
Interval 4916.7 to 10451.4
8157.4 titer
Interval 5738.9 to 11595.1
8344.8 titer
Interval 5632.6 to 12363.1
10091.6 titer
Interval 7429.1 to 13708.3
11463.3 titer
Interval 8532.4 to 15400.8
11464.2 titer
Interval 8344.3 to 15750.7
12503.4 titer
Interval 9048.2 to 17278.0
11949.2 titer
Interval 8770.5 to 16280.0
14685.9 titer
Interval 12121.8 to 17792.3
18941.5 titer
Interval 15945.2 to 22500.8
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.
Day 181
6903.6 titer
Interval 5136.3 to 9279.0
7562.1 titer
Interval 5654.8 to 10112.8
8909.5 titer
Interval 6694.5 to 11857.3
7621.8 titer
Interval 5919.8 to 9813.1
9964.2 titer
Interval 7705.7 to 12884.7
13012.4 titer
Interval 9511.7 to 17801.4
6369.6 titer
Interval 4220.6 to 9613.0
7294.8 titer
Interval 5036.4 to 10565.9
7954.9 titer
Interval 5434.1 to 11644.9
9107.1 titer
Interval 6525.4 to 12710.2
10985.5 titer
Interval 7501.6 to 16087.3
12634.3 titer
Interval 8474.3 to 18836.5
10278.3 titer
Interval 6394.0 to 16522.4
13441.8 titer
Interval 9717.9 to 18592.7
11401.6 titer
Interval 9285.0 to 14000.7
12407.1 titer
Interval 9795.0 to 15715.9
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.
Day 271
11298.3 titer
Interval 8553.7 to 14923.5
12807.0 titer
Interval 10031.3 to 16350.8
12567.4 titer
Interval 9669.8 to 16333.4
11943.9 titer
Interval 9633.0 to 14809.2
12712.9 titer
Interval 9740.9 to 16591.7
15654.4 titer
Interval 11271.3 to 21741.9
7715.8 titer
Interval 5167.5 to 11520.9
7211.2 titer
Interval 4925.9 to 10556.8
10557.7 titer
Interval 7065.3 to 15776.5
9559.5 titer
Interval 6174.7 to 14799.9
10701.5 titer
Interval 6765.3 to 16928.0
12557.1 titer
Interval 8887.5 to 17741.8
10729.0 titer
Interval 7461.8 to 15426.7
13065.9 titer
Interval 9274.8 to 18406.7
9755.4 titer
Interval 7882.1 to 12073.9
10562.7 titer
Interval 8377.0 to 13318.6
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in One Dose Groups.
Day 366
8671.6 titer
Interval 6723.5 to 11184.1
8756.9 titer
Interval 6440.1 to 11907.3
8552.4 titer
Interval 6376.5 to 11470.6
8065.4 titer
Interval 6207.8 to 10478.8
9784.4 titer
Interval 7382.6 to 12967.6
13214.9 titer
Interval 9643.9 to 18108.1
7644.9 titer
Interval 5080.0 to 11504.8
6661.2 titer
Interval 4285.1 to 10354.8
9652.1 titer
Interval 6186.6 to 15059.1
12279.8 titer
Interval 8351.9 to 18054.8
12341.7 titer
Interval 8245.4 to 18473.2
13314.0 titer
Interval 9596.9 to 18470.8
10449.0 titer
Interval 7002.5 to 15591.9
14255.0 titer
Interval 9505.4 to 21377.9
8366.7 titer
Interval 6770.6 to 10339.1
8509.6 titer
Interval 6732.7 to 10755.6
—

PRIMARY outcome

Timeframe: 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).

Geometric Mean (GM) of Pseudovirus Neutralization Against D614G.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.
Day 1
3358.3 titer
Interval 2495.4 to 4519.7
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.
Day 15
17962.2 titer
Interval 13481.6 to 23932.0
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.
Day 29
12816.7 titer
Interval 9298.0 to 17667.2
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.
Day 57
11171.5 titer
Interval 8416.8 to 14827.9
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.
Day 85
16328.8 titer
Interval 12496.7 to 21335.9
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.
Day 147
9988.4 titer
Interval 7645.1 to 13050.0
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.
Day 237
12128.0 titer
Interval 9225.4 to 15943.8
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.
Day 327
8859.3 titer
Interval 6651.5 to 11799.9
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against D614G in Two Dose Group.
Day 422
10156.6 titer
Interval 7417.9 to 13906.4
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 1
810.8 titer
Interval 575.1 to 1143.2
1069.4 titer
Interval 791.3 to 1445.1
862.6 titer
Interval 609.1 to 1221.6
933.8 titer
Interval 648.2 to 1345.2
963.6 titer
Interval 682.3 to 1360.8
1223.6 titer
Interval 705.0 to 2123.6
1056.9 titer
Interval 630.2 to 1772.2
922.8 titer
Interval 549.7 to 1548.9
977.0 titer
Interval 583.6 to 1635.6
1183.1 titer
Interval 730.7 to 1915.5
1065.4 titer
Interval 617.0 to 1839.6
1426.0 titer
Interval 805.6 to 2524.0
863.5 titer
Interval 453.6 to 1643.8
1556.0 titer
Interval 885.9 to 2732.7
2821.0 titer
Interval 2160.5 to 3683.3
2871.5 titer
Interval 2143.5 to 3846.8
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 15
7678.4 titer
Interval 6047.9 to 9748.5
13422.2 titer
Interval 10731.1 to 16788.1
9926.8 titer
Interval 7393.7 to 13327.9
11214.3 titer
Interval 8583.3 to 14651.8
10820.3 titer
Interval 8304.5 to 14098.3
7611.7 titer
Interval 5395.7 to 10737.7
8476.8 titer
Interval 5772.1 to 12449.0
8830.1 titer
Interval 6233.6 to 12508.2
10447.5 titer
Interval 7092.5 to 15389.3
9901.1 titer
Interval 7124.1 to 13760.6
11367.9 titer
Interval 7962.3 to 16230.0
2849.5 titer
Interval 1917.7 to 4233.9
5099.4 titer
Interval 3623.4 to 7176.6
5075.6 titer
Interval 3582.4 to 7191.2
15520.2 titer
Interval 12922.7 to 18639.9
19051.8 titer
Interval 15893.6 to 22837.4
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 29
4815.7 titer
Interval 3673.9 to 6312.4
9771.6 titer
Interval 7840.6 to 12178.0
6919.2 titer
Interval 5121.9 to 9347.2
7551.7 titer
Interval 5771.2 to 9881.6
6790.7 titer
Interval 5021.5 to 9183.2
5266.4 titer
Interval 3842.1 to 7218.6
7961.0 titer
Interval 5445.0 to 11639.5
8652.2 titer
Interval 6017.6 to 12440.2
9007.8 titer
Interval 6131.2 to 13234.0
8014.2 titer
Interval 5812.4 to 11050.1
9167.2 titer
Interval 6353.9 to 13226.3
4081.5 titer
Interval 2773.6 to 6006.1
8285.2 titer
Interval 5408.7 to 12691.3
8103.0 titer
Interval 5628.4 to 11665.6
13674.7 titer
Interval 10962.7 to 17057.6
16252.8 titer
Interval 13337.6 to 19805.1
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 91
3575.3 titer
Interval 2573.1 to 4967.7
7029.6 titer
Interval 5367.1 to 9207.0
5685.7 titer
Interval 4010.9 to 8059.8
6703.6 titer
Interval 4998.4 to 8990.5
6534.1 titer
Interval 4915.0 to 8686.5
2742.8 titer
Interval 1842.9 to 4081.9
3778.1 titer
Interval 2490.6 to 5731.3
4135.7 titer
Interval 2700.0 to 6334.9
4507.0 titer
Interval 2907.1 to 6987.4
4316.6 titer
Interval 3000.1 to 6210.6
4879.2 titer
Interval 3250.9 to 7323.0
4194.0 titer
Interval 2779.8 to 6327.6
6814.3 titer
Interval 4711.6 to 9855.5
5876.1 titer
Interval 3975.4 to 8685.5
6168.0 titer
Interval 4943.1 to 7696.4
7758.5 titer
Interval 6231.9 to 9658.9
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 181
2033.2 titer
Interval 1443.9 to 2863.0
3466.0 titer
Interval 2460.9 to 4881.5
2804.2 titer
Interval 1905.6 to 4126.7
3370.8 titer
Interval 2516.2 to 4515.6
4008.9 titer
Interval 3015.1 to 5330.2
4110.3 titer
Interval 2739.6 to 6166.9
2625.3 titer
Interval 1710.6 to 4029.0
2624.9 titer
Interval 1628.1 to 4231.9
3150.5 titer
Interval 2069.5 to 4796.0
2791.2 titer
Interval 1821.5 to 4277.2
3566.1 titer
Interval 2122.6 to 5991.3
4227.2 titer
Interval 2765.5 to 6461.3
4814.4 titer
Interval 2895.5 to 8004.8
6141.5 titer
Interval 4216.7 to 8944.9
5741.9 titer
Interval 4433.6 to 7436.3
6041.1 titer
Interval 4629.0 to 7884.1
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 271
3423.4 titer
Interval 2387.2 to 4909.3
5039.4 titer
Interval 3659.0 to 6940.6
3938.1 titer
Interval 2854.8 to 5432.4
4442.3 titer
Interval 3348.2 to 5893.9
4766.7 titer
Interval 3544.9 to 6409.7
7104.4 titer
Interval 4649.9 to 10854.5
4105.5 titer
Interval 2634.2 to 6398.6
3133.2 titer
Interval 1992.4 to 4927.1
4943.1 titer
Interval 3054.2 to 8000.3
4537.9 titer
Interval 2802.9 to 7346.8
5236.9 titer
Interval 3117.4 to 8797.4
5853.2 titer
Interval 4080.6 to 8395.6
6449.5 titer
Interval 4256.0 to 9773.5
7143.7 titer
Interval 4754.8 to 10732.7
3588.4 titer
Interval 2776.1 to 4638.3
3622.5 titer
Interval 2819.5 to 4654.4
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 366
2857.4 titer
Interval 2084.8 to 3916.4
3796.1 titer
Interval 2709.6 to 5318.1
2829.1 titer
Interval 2003.5 to 3994.9
3126.2 titer
Interval 2305.1 to 4239.7
3498.5 titer
Interval 2497.4 to 4900.8
4782.9 titer
Interval 3210.1 to 7126.3
3221.4 titer
Interval 2083.5 to 4980.7
2377.1 titer
Interval 1522.8 to 3710.6
4056.6 titer
Interval 2538.9 to 6481.6
3906.0 titer
Interval 2435.9 to 6263.4
4325.9 titer
Interval 2713.3 to 6897.2
4472.8 titer
Interval 3134.2 to 6383.2
3796.0 titer
Interval 2222.7 to 6483.0
5337.7 titer
Interval 3410.3 to 8354.5
4041.5 titer
Interval 3153.9 to 5178.8
4026.9 titer
Interval 3119.8 to 5197.9
—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 1
847.0 titer
Interval 583.8 to 1228.9
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 15
11275.7 titer
Interval 8306.0 to 15307.1
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 29
7800.2 titer
Interval 5548.0 to 10966.6
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 57
6008.9 titer
Interval 4426.1 to 8157.6
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 85
10285.2 titer
Interval 7694.0 to 13749.1
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 147
5061.1 titer
Interval 3755.3 to 6821.1
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 237
5362.8 titer
Interval 3812.3 to 7543.9
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 327
4295.6 titer
Interval 3036.0 to 6078.0
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 422
3780.4 titer
Interval 2636.4 to 5420.9
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 1
1602.4 titer
Interval 1174.8 to 2185.7
1842.0 titer
Interval 1373.9 to 2469.6
1783.4 titer
Interval 1316.2 to 2416.4
1898.6 titer
Interval 1430.1 to 2520.6
1771.4 titer
Interval 1279.3 to 2453.0
2261.3 titer
Interval 1434.3 to 3565.0
1753.6 titer
Interval 1107.8 to 2775.8
1775.8 titer
Interval 1171.4 to 2692.2
1849.3 titer
Interval 1125.3 to 3039.1
2232.5 titer
Interval 1526.5 to 3265.1
2032.3 titer
Interval 1330.4 to 3104.6
2679.5 titer
Interval 1774.8 to 4045.4
1750.1 titer
Interval 1001.0 to 3059.8
2493.9 titer
Interval 1537.8 to 4044.4
3315.7 titer
Interval 2635.0 to 4172.1
3637.2 titer
Interval 2844.8 to 4650.3
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 15
11566.9 titer
Interval 9470.4 to 14127.6
13447.7 titer
Interval 10965.6 to 16491.6
14581.1 titer
Interval 11343.1 to 18743.3
11575.4 titer
Interval 9504.5 to 14097.4
13975.9 titer
Interval 11085.6 to 17619.8
10868.1 titer
Interval 8185.9 to 14429.0
8689.0 titer
Interval 6094.6 to 12387.8
8705.4 titer
Interval 6258.6 to 12109.0
9519.2 titer
Interval 6726.2 to 13472.1
12004.8 titer
Interval 9161.0 to 15731.3
13331.1 titer
Interval 9916.6 to 17921.3
3666.9 titer
Interval 2627.6 to 5117.3
5005.2 titer
Interval 3636.1 to 6889.9
4820.9 titer
Interval 3611.4 to 6435.5
14610.6 titer
Interval 12510.1 to 17063.9
18199.3 titer
Interval 15594.2 to 21239.6
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 29
7899.3 titer
Interval 6367.4 to 9799.7
9742.0 titer
Interval 7994.1 to 11872.1
11005.1 titer
Interval 8637.1 to 14022.2
8256.2 titer
Interval 6796.3 to 10029.6
9696.2 titer
Interval 7590.3 to 12386.3
8444.4 titer
Interval 6585.2 to 10828.4
9095.1 titer
Interval 7075.8 to 11690.5
8504.4 titer
Interval 6009.9 to 12034.2
9067.6 titer
Interval 6354.4 to 12939.3
10754.4 titer
Interval 7991.5 to 14472.5
11738.3 titer
Interval 8902.5 to 15477.4
5768.5 titer
Interval 4208.2 to 7907.3
8746.4 titer
Interval 6041.2 to 12663.0
8863.7 titer
Interval 6491.9 to 12102.0
13482.3 titer
Interval 11287.1 to 16104.5
16409.4 titer
Interval 13763.9 to 19563.5
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 91
5329.5 titer
Interval 3999.3 to 7102.1
7977.7 titer
Interval 6321.4 to 10068.0
8256.9 titer
Interval 6229.2 to 10944.7
7267.3 titer
Interval 5609.0 to 9415.7
8651.8 titer
Interval 6889.2 to 10865.3
4874.8 titer
Interval 3636.6 to 6534.5
4253.7 titer
Interval 2920.9 to 6194.6
4854.3 titer
Interval 3328.6 to 7079.3
4709.7 titer
Interval 3141.7 to 7060.2
5475.8 titer
Interval 4076.3 to 7355.8
6208.7 titer
Interval 4502.6 to 8561.1
5543.9 titer
Interval 3922.4 to 7835.6
7065.7 titer
Interval 5057.1 to 9872.3
6475.1 titer
Interval 4668.5 to 8981.0
6349.1 titer
Interval 5282.5 to 7631.0
8184.0 titer
Interval 6789.8 to 9864.5
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 181
2933.9 titer
Interval 2183.6 to 3942.0
3564.8 titer
Interval 2637.9 to 4817.4
3824.7 titer
Interval 2824.2 to 5179.6
3499.3 titer
Interval 2740.4 to 4468.5
4143.8 titer
Interval 3140.3 to 5468.1
5684.5 titer
Interval 4062.5 to 7954.1
2797.9 titer
Interval 1901.6 to 4116.6
3337.3 titer
Interval 2232.2 to 4989.5
3323.3 titer
Interval 2224.6 to 4964.6
4026.4 titer
Interval 2909.5 to 5572.0
4109.5 titer
Interval 2657.3 to 6355.5
4968.0 titer
Interval 3436.3 to 7182.4
5343.6 titer
Interval 3331.9 to 8569.9
6290.0 titer
Interval 4603.3 to 8594.8
5798.8 titer
Interval 4722.9 to 7119.7
6884.7 titer
Interval 5448.9 to 8698.9
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 271
4773.6 titer
Interval 3608.9 to 6314.1
5270.2 titer
Interval 3985.1 to 6969.7
4992.4 titer
Interval 3750.8 to 6645.1
5022.5 titer
Interval 3971.7 to 6351.3
5294.9 titer
Interval 4064.0 to 6898.7
7566.2 titer
Interval 5348.9 to 10702.8
3649.7 titer
Interval 2459.8 to 5415.4
3360.2 titer
Interval 2234.3 to 5053.6
4730.2 titer
Interval 3074.0 to 7278.8
4792.7 titer
Interval 3112.0 to 7381.2
5104.3 titer
Interval 3208.7 to 8119.7
6223.0 titer
Interval 4405.2 to 8791.0
5963.9 titer
Interval 4020.2 to 8847.4
6591.1 titer
Interval 4608.9 to 9425.8
4604.6 titer
Interval 3741.6 to 5666.7
5006.9 titer
Interval 3957.9 to 6334.0
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 366
3949.6 titer
Interval 3028.8 to 5150.3
4289.1 titer
Interval 3093.2 to 5947.3
4011.9 titer
Interval 2968.1 to 5422.8
3690.3 titer
Interval 2835.2 to 4803.3
4186.9 titer
Interval 3078.7 to 5694.0
6333.9 titer
Interval 4596.5 to 8727.9
3663.3 titer
Interval 2440.5 to 5498.7
3161.0 titer
Interval 2058.7 to 4853.5
4490.3 titer
Interval 2921.9 to 6900.5
5671.3 titer
Interval 3836.8 to 8382.7
5700.1 titer
Interval 3730.7 to 8709.1
5301.9 titer
Interval 3793.0 to 7410.9
4295.2 titer
Interval 2611.0 to 7065.8
6388.3 titer
Interval 4296.9 to 9497.8
5333.6 titer
Interval 4300.9 to 6614.3
5745.6 titer
Interval 4521.9 to 7300.6
—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 1
1508.5 titer
Interval 1079.6 to 2107.8
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 15
10135.8 titer
Interval 7387.8 to 13905.9
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 29
7478.5 titer
Interval 5461.1 to 10241.1
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 57
6256.1 titer
Interval 4713.1 to 8304.1
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 85
9866.0 titer
Interval 7520.7 to 12942.7
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 147
5012.4 titer
Interval 3723.0 to 6748.3
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 237
5004.8 titer
Interval 3673.2 to 6819.2
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 327
3856.0 titer
Interval 2814.3 to 5283.2
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 422
3919.6 titer
Interval 2825.7 to 5437.0
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 366
1235.0 titer
Interval 853.9 to 1786.4
2217.1 titer
Interval 1542.4 to 3187.0
1987.9 titer
Interval 1402.9 to 2816.9
2012.2 titer
Interval 1493.1 to 2711.7
2032.1 titer
Interval 1439.1 to 2869.4
2218.4 titer
Interval 1463.1 to 3363.7
1998.1 titer
Interval 1258.7 to 3171.8
1943.4 titer
Interval 1217.9 to 3101.1
1824.1 titer
Interval 1074.4 to 3097.1
2355.2 titer
Interval 1414.7 to 3920.9
3247.7 titer
Interval 1958.8 to 5384.9
2270.8 titer
Interval 1442.0 to 3576.0
1985.3 titer
Interval 1110.9 to 3547.9
2335.7 titer
Interval 1355.9 to 4023.6
2538.8 titer
Interval 1942.3 to 3318.5
2007.4 titer
Interval 1569.1 to 2568.0
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 1
264.4 titer
Interval 185.4 to 377.1
311.2 titer
Interval 222.9 to 434.5
278.1 titer
Interval 194.3 to 397.9
343.8 titer
Interval 237.8 to 497.0
348.4 titer
Interval 241.3 to 503.1
420.3 titer
Interval 230.7 to 765.9
306.8 titer
Interval 177.1 to 531.6
329.8 titer
Interval 197.2 to 551.4
271.2 titer
Interval 156.9 to 468.8
360.2 titer
Interval 207.2 to 626.2
346.4 titer
Interval 189.2 to 634.0
413.6 titer
Interval 227.3 to 752.7
291.6 titer
Interval 154.4 to 550.7
366.2 titer
Interval 207.0 to 647.8
1103.1 titer
Interval 838.7 to 1450.9
1002.9 titer
Interval 727.4 to 1382.7
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 15
2669.9 titer
Interval 2028.0 to 3515.0
5278.9 titer
Interval 4017.1 to 6936.9
4544.2 titer
Interval 3339.9 to 6182.6
6014.6 titer
Interval 4656.4 to 7768.9
5339.3 titer
Interval 4039.5 to 7057.3
2662.2 titer
Interval 1806.4 to 3923.5
3753.3 titer
Interval 2543.2 to 5539.3
4781.7 titer
Interval 3304.3 to 6919.5
3315.5 titer
Interval 2140.0 to 5136.6
3570.4 titer
Interval 2507.8 to 5083.3
5544.3 titer
Interval 3788.8 to 8113.1
1221.8 titer
Interval 796.0 to 1875.6
1966.6 titer
Interval 1309.5 to 2953.5
1636.0 titer
Interval 1067.1 to 2508.2
6558.3 titer
Interval 5249.4 to 8193.5
6511.2 titer
Interval 5112.8 to 8291.9
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 29
1863.8 titer
Interval 1438.3 to 2415.2
3967.2 titer
Interval 3043.9 to 5170.7
3320.9 titer
Interval 2447.7 to 4505.8
3994.1 titer
Interval 3081.7 to 5176.6
3520.8 titer
Interval 2585.9 to 4793.7
1602.1 titer
Interval 1100.9 to 2331.6
2532.9 titer
Interval 1705.8 to 3761.0
3852.6 titer
Interval 2721.7 to 5453.2
2301.1 titer
Interval 1549.8 to 3416.7
2547.3 titer
Interval 1788.9 to 3627.2
3285.6 titer
Interval 2210.9 to 4882.7
1071.7 titer
Interval 644.2 to 1783.0
2367.4 titer
Interval 1475.1 to 3799.4
1824.4 titer
Interval 1151.5 to 2890.6
5211.8 titer
Interval 4210.1 to 6451.9
5056.7 titer
Interval 3935.1 to 6498.1
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 91
1095.3 titer
Interval 804.3 to 1491.7
2492.5 titer
Interval 1850.4 to 3357.5
2234.9 titer
Interval 1604.1 to 3113.7
2382.6 titer
Interval 1754.9 to 3234.8
2460.1 titer
Interval 1766.4 to 3426.1
1228.7 titer
Interval 796.7 to 1894.8
1851.5 titer
Interval 1151.8 to 2976.2
3011.7 titer
Interval 2016.3 to 4498.4
1728.7 titer
Interval 1064.2 to 2808.3
1895.6 titer
Interval 1228.8 to 2924.1
2726.7 titer
Interval 1732.5 to 4291.4
1247.1 titer
Interval 798.4 to 1947.9
1756.6 titer
Interval 1117.6 to 2760.8
1471.8 titer
Interval 874.5 to 2477.2
3954.1 titer
Interval 3130.7 to 4994.0
3963.2 titer
Interval 3131.0 to 5016.5
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 181
741.1 titer
Interval 512.2 to 1072.5
1583.8 titer
Interval 1125.1 to 2229.5
1226.9 titer
Interval 833.8 to 1805.4
1634.9 titer
Interval 1197.4 to 2232.2
1721.4 titer
Interval 1248.5 to 2373.3
1801.7 titer
Interval 1137.3 to 2854.0
1214.8 titer
Interval 728.5 to 2025.7
1859.4 titer
Interval 1174.6 to 2943.6
1299.1 titer
Interval 815.5 to 2069.6
1413.4 titer
Interval 876.4 to 2279.3
2021.5 titer
Interval 1183.2 to 3453.7
1939.9 titer
Interval 1249.8 to 3011.1
2541.8 titer
Interval 1484.8 to 4351.3
2310.1 titer
Interval 1527.5 to 3493.8
3361.6 titer
Interval 2601.1 to 4344.6
3263.9 titer
Interval 2510.9 to 4242.8
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 271
1552.1 titer
Interval 1096.0 to 2198.2
2453.0 titer
Interval 1770.3 to 3399.0
2403.2 titer
Interval 1736.1 to 3326.7
2549.8 titer
Interval 1928.9 to 3370.5
2770.2 titer
Interval 2068.1 to 3710.6
3236.6 titer
Interval 2097.5 to 4994.4
2107.2 titer
Interval 1356.9 to 3272.5
1995.1 titer
Interval 1252.2 to 3178.7
1902.3 titer
Interval 1124.3 to 3219.0
2000.0 titer
Interval 1217.3 to 3286.1
2744.7 titer
Interval 1607.9 to 4685.1
2654.2 titer
Interval 1726.3 to 4080.8
2027.9 titer
Interval 1117.3 to 3680.5
2463.5 titer
Interval 1518.6 to 3996.3
2818.0 titer
Interval 2150.0 to 3693.6
2401.5 titer
Interval 1828.0 to 3155.0
—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 1
249.7 titer
Interval 166.7 to 374.1
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 15
4289.3 titer
Interval 2993.6 to 6145.7
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 29
3235.4 titer
Interval 2275.0 to 4601.3
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 57
2322.2 titer
Interval 1628.0 to 3312.5
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 85
4111.6 titer
Interval 3062.5 to 5520.2
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 147
2616.7 titer
Interval 1867.5 to 3666.4
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 237
2088.0 titer
Interval 1490.7 to 2924.7
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 327
2006.1 titer
Interval 1382.0 to 2911.9
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 422
2136.6 titer
Interval 1418.6 to 3218.0
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=25 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=25 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=25 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=25 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=25 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.
Day 1
173.5 titer
Interval 92.9 to 323.7
209.1 titer
Interval 105.8 to 413.0
217.0 titer
Interval 107.5 to 438.2
352.9 titer
Interval 193.9 to 642.6
345.2 titer
Interval 186.7 to 638.3
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.
Day 15
1879.9 titer
Interval 1232.3 to 2868.0
1952.8 titer
Interval 1081.1 to 3527.3
2569.9 titer
Interval 1529.1 to 4319.2
3181.1 titer
Interval 2028.8 to 4987.9
2986.1 titer
Interval 1921.3 to 4641.2
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 29
1035.7 titer
Interval 755.2 to 1420.4
1766.3 titer
Interval 1322.1 to 2359.8
1850.9 titer
Interval 1331.7 to 2572.7
1631.5 titer
Interval 1237.3 to 2151.3
1665.5 titer
Interval 1234.7 to 2246.6
870.9 titer
Interval 590.4 to 1284.6
1303.8 titer
Interval 899.6 to 1889.6
1754.5 titer
Interval 1181.4 to 2605.5
1397.6 titer
Interval 943.6 to 2070.0
1458.4 titer
Interval 1009.7 to 2106.6
1680.7 titer
Interval 1063.5 to 2656.0
948.1 titer
Interval 599.9 to 1498.5
1274.8 titer
Interval 799.1 to 2033.7
1463.9 titer
Interval 977.7 to 2191.8
3104.8 titer
Interval 2511.5 to 3838.3
4881.1 titer
Interval 3817.9 to 6240.5
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 1
155.3 titer
Interval 108.9 to 221.5
170.8 titer
Interval 121.3 to 240.7
152.0 titer
Interval 108.0 to 213.9
195.4 titer
Interval 136.7 to 279.3
174.0 titer
Interval 119.5 to 253.3
206.8 titer
Interval 124.0 to 344.8
155.3 titer
Interval 94.3 to 255.9
183.7 titer
Interval 113.2 to 298.1
148.6 titer
Interval 91.5 to 241.3
150.1 titer
Interval 90.2 to 249.6
184.0 titer
Interval 106.9 to 316.9
257.6 titer
Interval 141.6 to 468.6
195.6 titer
Interval 108.1 to 353.9
254.8 titer
Interval 143.0 to 454.1
768.6 titer
Interval 565.0 to 1045.6
735.1 titer
Interval 533.9 to 1012.2
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 15
1214.7 titer
Interval 815.9 to 1808.5
1349.8 titer
Interval 760.2 to 2396.8
1812.1 titer
Interval 1063.8 to 3086.9
2036.2 titer
Interval 1302.5 to 3183.2
1832.5 titer
Interval 1082.9 to 3100.8
—
—
—
169.0 titer
95% confidence interval was not estimable as data from only 1 participant was analyzed
—
—
767.3 titer
Interval 474.6 to 1240.3
1084.3 titer
Interval 711.8 to 1651.9
1144.8 titer
Interval 766.8 to 1709.4
3577.0 titer
Interval 2894.3 to 4420.7
5906.9 titer
Interval 4617.4 to 7556.6
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 91
756.3 titer
Interval 523.6 to 1092.5
1503.2 titer
Interval 1093.9 to 2065.6
1367.4 titer
Interval 962.2 to 1943.3
1297.3 titer
Interval 931.0 to 1807.7
1363.4 titer
Interval 987.9 to 1881.5
785.8 titer
Interval 475.4 to 1298.9
1032.5 titer
Interval 667.5 to 1597.2
1221.7 titer
Interval 744.6 to 2004.5
950.7 titer
Interval 535.5 to 1687.9
1021.8 titer
Interval 643.4 to 1622.7
1313.7 titer
Interval 795.7 to 2168.8
830.6 titer
Interval 493.5 to 1398.1
1201.3 titer
Interval 776.7 to 1858.2
1247.7 titer
Interval 763.0 to 2040.5
2163.2 titer
Interval 1676.3 to 2791.4
3774.7 titer
Interval 2960.5 to 4812.8
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 181
538.3 titer
Interval 354.5 to 817.4
1028.3 titer
Interval 714.5 to 1479.7
801.2 titer
Interval 547.5 to 1172.6
1037.4 titer
Interval 742.2 to 1450.1
1117.8 titer
Interval 788.8 to 1584.1
1327.5 titer
Interval 732.8 to 2405.1
707.8 titer
Interval 429.4 to 1166.5
971.0 titer
Interval 591.3 to 1594.5
868.4 titer
Interval 510.5 to 1477.3
824.6 titer
Interval 470.9 to 1444.1
1199.9 titer
Interval 694.2 to 2074.0
1460.0 titer
Interval 863.8 to 2467.5
1805.7 titer
Interval 1074.1 to 3035.6
1765.8 titer
Interval 1099.0 to 2837.2
2099.7 titer
Interval 1620.5 to 2720.5
3189.2 titer
Interval 2416.9 to 4208.3
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 271
1437.9 titer
Interval 981.0 to 2107.5
1951.1 titer
Interval 1399.6 to 2719.9
1733.1 titer
Interval 1237.6 to 2426.9
1950.2 titer
Interval 1412.5 to 2692.5
2023.5 titer
Interval 1469.2 to 2786.8
2655.1 titer
Interval 1512.9 to 4659.5
1451.4 titer
Interval 906.8 to 2323.1
1290.0 titer
Interval 808.6 to 2058.2
1620.4 titer
Interval 896.6 to 2928.6
1468.9 titer
Interval 838.9 to 2572.0
1727.2 titer
Interval 980.4 to 3042.8
2211.5 titer
Interval 1401.5 to 3489.8
1670.7 titer
Interval 976.1 to 2859.7
2263.3 titer
Interval 1433.7 to 3572.9
1843.8 titer
Interval 1416.4 to 2400.0
2419.0 titer
Interval 1826.0 to 3204.5
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 366
1208.4 titer
Interval 820.2 to 1780.3
1793.9 titer
Interval 1225.3 to 2626.4
1567.6 titer
Interval 1108.1 to 2217.8
1633.8 titer
Interval 1173.1 to 2275.3
1472.2 titer
Interval 1007.8 to 2150.5
2378.5 titer
Interval 1393.3 to 4060.6
1378.2 titer
Interval 846.0 to 2245.2
1180.6 titer
Interval 721.1 to 1932.9
1628.2 titer
Interval 899.4 to 2947.7
1972.5 titer
Interval 1163.4 to 3344.0
2122.8 titer
Interval 1179.5 to 3820.7
1993.5 titer
Interval 1208.8 to 3287.5
1628.0 titer
Interval 915.4 to 2895.1
2319.4 titer
Interval 1376.1 to 3909.6
1770.2 titer
Interval 1375.9 to 2277.6
2041.4 titer
Interval 1568.2 to 2657.3
—

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 1
132.1 titer
Interval 90.2 to 193.5
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 15
816.0 titer
95% confidence interval is not estimable as data from only 1 participant was analyzed.
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 29
1416.8 titer
Interval 1004.5 to 1998.3
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 57
1148.9 titer
Interval 828.8 to 1592.6
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 85
2029.1 titer
Interval 1533.2 to 2685.4
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 147
1195.3 titer
Interval 832.1 to 1716.9
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 237
1407.5 titer
Interval 963.9 to 2055.2
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 327
1419.5 titer
Interval 949.1 to 2123.1
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean (GM) of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 422
1569.2 titer
Interval 1016.0 to 2423.6
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 1
0.25 ratio
Interval 0.21 to 0.29
0.27 ratio
Interval 0.22 to 0.33
0.24 ratio
Interval 0.21 to 0.29
0.24 ratio
Interval 0.2 to 0.29
0.27 ratio
Interval 0.23 to 0.31
0.26 ratio
Interval 0.2 to 0.32
0.28 ratio
Interval 0.22 to 0.36
0.23 ratio
Interval 0.18 to 0.29
0.26 ratio
Interval 0.21 to 0.33
0.27 ratio
Interval 0.21 to 0.33
0.23 ratio
Interval 0.17 to 0.3
0.27 ratio
Interval 0.21 to 0.37
0.25 ratio
Interval 0.19 to 0.34
0.29 ratio
Interval 0.21 to 0.39
0.38 ratio
Interval 0.34 to 0.42
0.37 ratio
Interval 0.32 to 0.42
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 15
0.36 ratio
Interval 0.33 to 0.41
0.62 ratio
Interval 0.57 to 0.68
0.41 ratio
Interval 0.36 to 0.46
0.58 ratio
Interval 0.5 to 0.68
0.41 ratio
Interval 0.35 to 0.49
0.35 ratio
Interval 0.3 to 0.42
0.57 ratio
Interval 0.5 to 0.64
0.56 ratio
Interval 0.49 to 0.64
0.55 ratio
Interval 0.48 to 0.64
0.44 ratio
Interval 0.39 to 0.5
0.40 ratio
Interval 0.33 to 0.48
0.35 ratio
Interval 0.3 to 0.41
0.53 ratio
Interval 0.47 to 0.59
0.51 ratio
Interval 0.45 to 0.57
0.56 ratio
Interval 0.52 to 0.61
0.57 ratio
Interval 0.52 to 0.62
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 29
0.30 ratio
Interval 0.25 to 0.36
0.58 ratio
Interval 0.53 to 0.63
0.38 ratio
Interval 0.33 to 0.43
0.53 ratio
Interval 0.44 to 0.63
0.38 ratio
Interval 0.32 to 0.46
0.32 ratio
Interval 0.27 to 0.38
0.50 ratio
Interval 0.38 to 0.66
0.56 ratio
Interval 0.49 to 0.64
0.57 ratio
Interval 0.5 to 0.66
0.41 ratio
Interval 0.36 to 0.46
0.38 ratio
Interval 0.32 to 0.46
0.39 ratio
Interval 0.33 to 0.47
0.60 ratio
Interval 0.52 to 0.69
0.55 ratio
Interval 0.48 to 0.62
0.43 ratio
Interval 0.39 to 0.48
0.45 ratio
Interval 0.4 to 0.49
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 91
0.31 ratio
Interval 0.27 to 0.35
0.49 ratio
Interval 0.44 to 0.54
0.34 ratio
Interval 0.3 to 0.39
0.47 ratio
Interval 0.4 to 0.55
0.39 ratio
Interval 0.34 to 0.45
0.31 ratio
Interval 0.25 to 0.38
0.53 ratio
Interval 0.46 to 0.6
0.51 ratio
Interval 0.44 to 0.58
0.54 ratio
Interval 0.47 to 0.62
0.43 ratio
Interval 0.38 to 0.48
0.43 ratio
Interval 0.35 to 0.51
0.37 ratio
Interval 0.31 to 0.43
0.54 ratio
Interval 0.47 to 0.63
0.49 ratio
Interval 0.43 to 0.56
0.42 ratio
Interval 0.38 to 0.46
0.41 ratio
Interval 0.36 to 0.46
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 181
0.29 ratio
Interval 0.26 to 0.34
0.46 ratio
Interval 0.39 to 0.54
0.31 ratio
Interval 0.26 to 0.39
0.44 ratio
Interval 0.4 to 0.49
0.40 ratio
Interval 0.33 to 0.49
0.32 ratio
Interval 0.27 to 0.38
0.41 ratio
Interval 0.36 to 0.48
0.36 ratio
Interval 0.3 to 0.43
0.40 ratio
Interval 0.34 to 0.46
0.31 ratio
Interval 0.25 to 0.37
0.32 ratio
Interval 0.25 to 0.42
0.33 ratio
Interval 0.29 to 0.39
0.47 ratio
Interval 0.41 to 0.54
0.46 ratio
Interval 0.4 to 0.52
0.50 ratio
Interval 0.44 to 0.57
0.49 ratio
Interval 0.43 to 0.55
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 271
0.30 ratio
Interval 0.25 to 0.36
0.39 ratio
Interval 0.33 to 0.47
0.31 ratio
Interval 0.26 to 0.38
0.37 ratio
Interval 0.31 to 0.44
0.37 ratio
Interval 0.33 to 0.42
0.45 ratio
Interval 0.38 to 0.55
0.53 ratio
Interval 0.46 to 0.62
0.43 ratio
Interval 0.35 to 0.54
0.47 ratio
Interval 0.4 to 0.54
0.47 ratio
Interval 0.41 to 0.55
0.49 ratio
Interval 0.41 to 0.59
0.47 ratio
Interval 0.4 to 0.55
0.60 ratio
Interval 0.51 to 0.71
0.55 ratio
Interval 0.46 to 0.65
0.37 ratio
Interval 0.33 to 0.41
0.34 ratio
Interval 0.31 to 0.38
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in One Dose Groups.
Day 366
0.33 ratio
Interval 0.28 to 0.38
0.43 ratio
Interval 0.39 to 0.48
0.33 ratio
Interval 0.27 to 0.4
0.39 ratio
Interval 0.34 to 0.45
0.36 ratio
Interval 0.3 to 0.43
0.36 ratio
Interval 0.3 to 0.43
0.42 ratio
Interval 0.35 to 0.5
0.36 ratio
Interval 0.3 to 0.42
0.42 ratio
Interval 0.36 to 0.49
0.32 ratio
Interval 0.27 to 0.38
0.35 ratio
Interval 0.29 to 0.42
0.34 ratio
Interval 0.28 to 0.4
0.36 ratio
Interval 0.25 to 0.52
0.37 ratio
Interval 0.32 to 0.44
0.48 ratio
Interval 0.43 to 0.54
0.47 ratio
Interval 0.42 to 0.53
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 1
0.25 ratio
Interval 0.21 to 0.31
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 15
0.63 ratio
Interval 0.57 to 0.69
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 29
0.61 ratio
Interval 0.55 to 0.67
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 57
0.54 ratio
Interval 0.49 to 0.6
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 85
0.63 ratio
Interval 0.58 to 0.69
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 147
0.51 ratio
Interval 0.46 to 0.56
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 237
0.44 ratio
Interval 0.37 to 0.53
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 327
0.48 ratio
Interval 0.41 to 0.58
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.351 in Two Dose Group.
Day 422
0.37 ratio
Interval 0.31 to 0.44
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 1
0.49 ratio
Interval 0.45 to 0.54
0.47 ratio
Interval 0.42 to 0.51
0.50 ratio
Interval 0.47 to 0.54
0.49 ratio
Interval 0.46 to 0.53
0.49 ratio
Interval 0.46 to 0.53
0.47 ratio
Interval 0.42 to 0.54
0.47 ratio
Interval 0.4 to 0.55
0.45 ratio
Interval 0.39 to 0.51
0.50 ratio
Interval 0.45 to 0.55
0.50 ratio
Interval 0.45 to 0.56
0.43 ratio
Interval 0.38 to 0.49
0.52 ratio
Interval 0.47 to 0.57
0.51 ratio
Interval 0.46 to 0.57
0.46 ratio
Interval 0.35 to 0.6
0.45 ratio
Interval 0.42 to 0.48
0.47 ratio
Interval 0.44 to 0.5
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 15
0.55 ratio
Interval 0.52 to 0.58
0.62 ratio
Interval 0.59 to 0.66
0.60 ratio
Interval 0.56 to 0.64
0.60 ratio
Interval 0.57 to 0.64
0.53 ratio
Interval 0.46 to 0.62
0.50 ratio
Interval 0.46 to 0.55
0.58 ratio
Interval 0.53 to 0.63
0.55 ratio
Interval 0.49 to 0.62
0.50 ratio
Interval 0.46 to 0.55
0.53 ratio
Interval 0.5 to 0.58
0.47 ratio
Interval 0.41 to 0.54
0.45 ratio
Interval 0.42 to 0.49
0.52 ratio
Interval 0.49 to 0.55
0.48 ratio
Interval 0.45 to 0.52
0.53 ratio
Interval 0.51 to 0.55
0.54 ratio
Interval 0.52 to 0.56
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 29
0.49 ratio
Interval 0.46 to 0.53
0.58 ratio
Interval 0.54 to 0.62
0.60 ratio
Interval 0.57 to 0.64
0.57 ratio
Interval 0.54 to 0.61
0.55 ratio
Interval 0.51 to 0.59
0.51 ratio
Interval 0.47 to 0.56
0.57 ratio
Interval 0.53 to 0.63
0.55 ratio
Interval 0.49 to 0.62
0.58 ratio
Interval 0.52 to 0.64
0.55 ratio
Interval 0.5 to 0.59
0.49 ratio
Interval 0.45 to 0.53
0.56 ratio
Interval 0.52 to 0.59
0.63 ratio
Interval 0.58 to 0.68
0.60 ratio
Interval 0.56 to 0.64
0.43 ratio
Interval 0.4 to 0.45
0.45 ratio
Interval 0.42 to 0.48
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 91
0.46 ratio
Interval 0.43 to 0.49
0.55 ratio
Interval 0.52 to 0.59
0.50 ratio
Interval 0.47 to 0.53
0.51 ratio
Interval 0.44 to 0.58
0.52 ratio
Interval 0.49 to 0.56
0.55 ratio
Interval 0.5 to 0.6
0.59 ratio
Interval 0.55 to 0.64
0.60 ratio
Interval 0.54 to 0.66
0.56 ratio
Interval 0.52 to 0.61
0.54 ratio
Interval 0.5 to 0.59
0.54 ratio
Interval 0.49 to 0.6
0.48 ratio
Interval 0.45 to 0.52
0.57 ratio
Interval 0.52 to 0.61
0.54 ratio
Interval 0.5 to 0.59
0.43 ratio
Interval 0.41 to 0.46
0.43 ratio
Interval 0.41 to 0.46
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 181
0.42 ratio
Interval 0.4 to 0.45
0.47 ratio
Interval 0.41 to 0.54
0.43 ratio
Interval 0.37 to 0.5
0.46 ratio
Interval 0.43 to 0.49
0.42 ratio
Interval 0.36 to 0.48
0.44 ratio
Interval 0.4 to 0.48
0.44 ratio
Interval 0.4 to 0.48
0.46 ratio
Interval 0.42 to 0.5
0.42 ratio
Interval 0.38 to 0.46
0.44 ratio
Interval 0.41 to 0.48
0.37 ratio
Interval 0.31 to 0.45
0.39 ratio
Interval 0.36 to 0.43
0.52 ratio
Interval 0.47 to 0.57
0.47 ratio
Interval 0.43 to 0.51
0.51 ratio
Interval 0.48 to 0.54
0.55 ratio
Interval 0.52 to 0.59
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 271
0.42 ratio
Interval 0.39 to 0.46
0.41 ratio
Interval 0.36 to 0.48
0.40 ratio
Interval 0.34 to 0.46
0.42 ratio
Interval 0.39 to 0.45
0.42 ratio
Interval 0.39 to 0.45
0.48 ratio
Interval 0.44 to 0.54
0.47 ratio
Interval 0.43 to 0.52
0.47 ratio
Interval 0.4 to 0.54
0.45 ratio
Interval 0.4 to 0.5
0.50 ratio
Interval 0.46 to 0.55
0.48 ratio
Interval 0.43 to 0.53
0.50 ratio
Interval 0.45 to 0.55
0.56 ratio
Interval 0.5 to 0.62
0.50 ratio
Interval 0.46 to 0.55
0.47 ratio
Interval 0.44 to 0.5
0.47 ratio
Interval 0.44 to 0.51
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in One Dose Groups.
Day 366
0.46 ratio
Interval 0.42 to 0.49
0.49 ratio
Interval 0.45 to 0.54
0.47 ratio
Interval 0.4 to 0.55
0.46 ratio
Interval 0.42 to 0.5
0.43 ratio
Interval 0.37 to 0.5
0.48 ratio
Interval 0.43 to 0.54
0.48 ratio
Interval 0.43 to 0.54
0.47 ratio
Interval 0.41 to 0.55
0.47 ratio
Interval 0.41 to 0.53
0.46 ratio
Interval 0.41 to 0.53
0.46 ratio
Interval 0.41 to 0.52
0.40 ratio
Interval 0.36 to 0.45
0.41 ratio
Interval 0.29 to 0.58
0.45 ratio
Interval 0.41 to 0.49
0.64 ratio
Interval 0.6 to 0.68
0.68 ratio
Interval 0.63 to 0.72
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 1
0.45 ratio
Interval 0.38 to 0.53
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 15
0.56 ratio
Interval 0.47 to 0.67
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 29
0.58 ratio
Interval 0.55 to 0.62
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 57
0.56 ratio
Interval 0.53 to 0.6
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 85
0.60 ratio
Interval 0.57 to 0.64
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 147
0.50 ratio
Interval 0.43 to 0.58
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 237
0.41 ratio
Interval 0.35 to 0.48
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 327
0.44 ratio
Interval 0.37 to 0.51
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against B.1.617.2 in Two Dose Group.
Day 422
0.39 ratio
Interval 0.33 to 0.45
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 91
0.09 ratio
Interval 0.08 to 0.11
0.17 ratio
Interval 0.15 to 0.2
0.13 ratio
Interval 0.11 to 0.16
0.17 ratio
Interval 0.14 to 0.2
0.15 ratio
Interval 0.12 to 0.19
0.14 ratio
Interval 0.11 to 0.18
0.26 ratio
Interval 0.21 to 0.32
0.37 ratio
Interval 0.31 to 0.43
0.21 ratio
Interval 0.17 to 0.25
0.19 ratio
Interval 0.15 to 0.23
0.24 ratio
Interval 0.18 to 0.31
0.11 ratio
Interval 0.09 to 0.14
0.14 ratio
Interval 0.09 to 0.22
0.12 ratio
Interval 0.09 to 0.17
0.27 ratio
Interval 0.24 to 0.3
0.21 ratio
Interval 0.18 to 0.24
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 29
0.12 ratio
Interval 0.1 to 0.14
0.24 ratio
Interval 0.2 to 0.28
0.18 ratio
Interval 0.15 to 0.22
0.28 ratio
Interval 0.24 to 0.33
0.20 ratio
Interval 0.16 to 0.24
0.10 ratio
Interval 0.08 to 0.12
0.16 ratio
Interval 0.12 to 0.21
0.25 ratio
Interval 0.21 to 0.29
0.15 ratio
Interval 0.12 to 0.18
0.13 ratio
Interval 0.11 to 0.16
0.14 ratio
Interval 0.11 to 0.17
0.10 ratio
Interval 0.07 to 0.14
0.17 ratio
Interval 0.11 to 0.26
0.12 ratio
Interval 0.09 to 0.17
0.17 ratio
Interval 0.14 to 0.19
0.14 ratio
Interval 0.11 to 0.17
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 1
0.08 ratio
Interval 0.07 to 0.1
0.08 ratio
Interval 0.07 to 0.09
0.08 ratio
Interval 0.06 to 0.1
0.09 ratio
Interval 0.07 to 0.11
0.10 ratio
Interval 0.08 to 0.12
0.09 ratio
Interval 0.07 to 0.12
0.08 ratio
Interval 0.06 to 0.11
0.08 ratio
Interval 0.06 to 0.11
0.07 ratio
Interval 0.05 to 0.1
0.08 ratio
Interval 0.06 to 0.11
0.07 ratio
Interval 0.05 to 0.11
0.08 ratio
Interval 0.06 to 0.11
0.08 ratio
Interval 0.06 to 0.12
0.07 ratio
Interval 0.05 to 0.09
0.15 ratio
Interval 0.13 to 0.17
0.13 ratio
Interval 0.11 to 0.16
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 15
0.13 ratio
Interval 0.11 to 0.15
0.25 ratio
Interval 0.21 to 0.29
0.19 ratio
Interval 0.16 to 0.22
0.31 ratio
Interval 0.27 to 0.36
0.20 ratio
Interval 0.17 to 0.24
0.12 ratio
Interval 0.1 to 0.16
0.25 ratio
Interval 0.21 to 0.3
0.30 ratio
Interval 0.26 to 0.35
0.18 ratio
Interval 0.15 to 0.21
0.16 ratio
Interval 0.13 to 0.19
0.20 ratio
Interval 0.16 to 0.24
0.15 ratio
Interval 0.12 to 0.19
0.20 ratio
Interval 0.15 to 0.27
0.16 ratio
Interval 0.12 to 0.22
0.24 ratio
Interval 0.21 to 0.27
0.19 ratio
Interval 0.16 to 0.23
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 181
0.11 ratio
Interval 0.09 to 0.13
0.21 ratio
Interval 0.18 to 0.25
0.14 ratio
Interval 0.11 to 0.17
0.21 ratio
Interval 0.18 to 0.25
0.17 ratio
Interval 0.14 to 0.21
0.14 ratio
Interval 0.11 to 0.18
0.19 ratio
Interval 0.14 to 0.26
0.25 ratio
Interval 0.21 to 0.31
0.16 ratio
Interval 0.13 to 0.21
0.16 ratio
Interval 0.12 to 0.2
0.18 ratio
Interval 0.13 to 0.25
0.15 ratio
Interval 0.12 to 0.19
0.25 ratio
Interval 0.19 to 0.32
0.17 ratio
Interval 0.14 to 0.22
0.29 ratio
Interval 0.26 to 0.33
0.26 ratio
Interval 0.23 to 0.3
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 271
0.14 ratio
Interval 0.11 to 0.16
0.19 ratio
Interval 0.16 to 0.23
0.19 ratio
Interval 0.16 to 0.23
0.21 ratio
Interval 0.18 to 0.25
0.22 ratio
Interval 0.19 to 0.25
0.21 ratio
Interval 0.16 to 0.27
0.27 ratio
Interval 0.23 to 0.32
0.28 ratio
Interval 0.21 to 0.37
0.18 ratio
Interval 0.14 to 0.23
0.21 ratio
Interval 0.17 to 0.26
0.26 ratio
Interval 0.2 to 0.32
0.21 ratio
Interval 0.17 to 0.26
0.19 ratio
Interval 0.11 to 0.32
0.19 ratio
Interval 0.14 to 0.25
0.29 ratio
Interval 0.25 to 0.33
0.23 ratio
Interval 0.2 to 0.26
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in One Dose Groups.
Day 366
0.14 ratio
Interval 0.11 to 0.18
0.25 ratio
Interval 0.22 to 0.3
0.23 ratio
Interval 0.19 to 0.28
0.25 ratio
Interval 0.21 to 0.29
0.21 ratio
Interval 0.17 to 0.25
0.17 ratio
Interval 0.13 to 0.21
0.26 ratio
Interval 0.21 to 0.32
0.29 ratio
Interval 0.24 to 0.36
0.19 ratio
Interval 0.15 to 0.24
0.19 ratio
Interval 0.15 to 0.25
0.26 ratio
Interval 0.21 to 0.32
0.17 ratio
Interval 0.13 to 0.22
0.19 ratio
Interval 0.11 to 0.32
0.16 ratio
Interval 0.12 to 0.22
0.30 ratio
Interval 0.27 to 0.34
0.24 ratio
Interval 0.2 to 0.27
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 1
0.07 ratio
Interval 0.06 to 0.1
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 15
0.24 ratio
Interval 0.2 to 0.29
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 29
0.25 ratio
Interval 0.22 to 0.29
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 57
0.21 ratio
Interval 0.17 to 0.25
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 85
0.25 ratio
Interval 0.22 to 0.29
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 147
0.26 ratio
Interval 0.22 to 0.32
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 237
0.17 ratio
Interval 0.14 to 0.21
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 327
0.23 ratio
Interval 0.19 to 0.28
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.1 in Two Dose Group.
Day 422
0.21 ratio
Interval 0.17 to 0.26
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=25 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=25 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=25 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=25 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=25 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.
Day 1
0.07 ratio
Interval 0.05 to 0.1
0.04 ratio
Interval 0.03 to 0.06
0.05 ratio
Interval 0.03 to 0.09
0.06 ratio
Interval 0.04 to 0.08
0.07 ratio
Interval 0.05 to 0.1
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.2.12.1 in One Dose Groups.
Day 15
0.11 ratio
Interval 0.08 to 0.15
0.13 ratio
Interval 0.09 to 0.2
0.12 ratio
Interval 0.09 to 0.16
0.18 ratio
Interval 0.14 to 0.22
0.14 ratio
Interval 0.11 to 0.18
—
—
—
—
—
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=97 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=49 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=48 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=100 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=100 Participants
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;
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;
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 1
0.05 ratio
Interval 0.04 to 0.06
0.04 ratio
Interval 0.03 to 0.05
0.04 ratio
Interval 0.03 to 0.05
0.05 ratio
Interval 0.04 to 0.06
0.05 ratio
Interval 0.04 to 0.06
0.04 ratio
Interval 0.04 to 0.06
0.04 ratio
Interval 0.03 to 0.06
0.05 ratio
Interval 0.04 to 0.06
0.04 ratio
Interval 0.03 to 0.06
0.03 ratio
Interval 0.03 to 0.05
0.04 ratio
Interval 0.03 to 0.05
0.05 ratio
Interval 0.04 to 0.07
0.06 ratio
Interval 0.04 to 0.08
0.05 ratio
Interval 0.03 to 0.06
0.10 ratio
Interval 0.09 to 0.12
0.09 ratio
Interval 0.08 to 0.11
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 15
0.07 ratio
Interval 0.06 to 0.09
0.09 ratio
Interval 0.06 to 0.13
0.08 ratio
Interval 0.06 to 0.11
0.11 ratio
Interval 0.1 to 0.14
0.09 ratio
Interval 0.06 to 0.12
—
—
—
0.11 ratio
95% confidence interval is not estimable as data from only 1 participant was analyzed.
—
—
0.09 ratio
Interval 0.07 to 0.12
0.11 ratio
Interval 0.08 to 0.16
0.11 ratio
Interval 0.09 to 0.15
0.13 ratio
Interval 0.11 to 0.15
0.18 ratio
Interval 0.15 to 0.21
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 29
0.06 ratio
Interval 0.05 to 0.08
0.11 ratio
Interval 0.09 to 0.13
0.10 ratio
Interval 0.08 to 0.13
0.11 ratio
Interval 0.09 to 0.14
0.09 ratio
Interval 0.08 to 0.11
0.05 ratio
Interval 0.04 to 0.07
0.08 ratio
Interval 0.06 to 0.11
0.11 ratio
Interval 0.09 to 0.14
0.09 ratio
Interval 0.07 to 0.11
0.07 ratio
Interval 0.06 to 0.09
0.07 ratio
Interval 0.05 to 0.09
0.09 ratio
Interval 0.07 to 0.12
0.09 ratio
Interval 0.06 to 0.14
0.10 ratio
Interval 0.08 to 0.13
0.10 ratio
Interval 0.09 to 0.11
0.13 ratio
Interval 0.11 to 0.16
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 91
0.06 ratio
Interval 0.05 to 0.08
0.10 ratio
Interval 0.09 to 0.13
0.08 ratio
Interval 0.07 to 0.1
0.09 ratio
Interval 0.07 to 0.11
0.08 ratio
Interval 0.07 to 0.1
0.09 ratio
Interval 0.06 to 0.12
0.14 ratio
Interval 0.12 to 0.18
0.15 ratio
Interval 0.11 to 0.2
0.11 ratio
Interval 0.09 to 0.15
0.10 ratio
Interval 0.08 to 0.13
0.11 ratio
Interval 0.08 to 0.16
0.07 ratio
Interval 0.05 to 0.1
0.10 ratio
Interval 0.06 to 0.14
0.10 ratio
Interval 0.08 to 0.14
0.15 ratio
Interval 0.13 to 0.17
0.20 ratio
Interval 0.17 to 0.23
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 181
0.08 ratio
Interval 0.06 to 0.1
0.14 ratio
Interval 0.11 to 0.16
0.09 ratio
Interval 0.07 to 0.11
0.14 ratio
Interval 0.11 to 0.16
0.11 ratio
Interval 0.09 to 0.14
0.10 ratio
Interval 0.07 to 0.15
0.11 ratio
Interval 0.08 to 0.15
0.13 ratio
Interval 0.1 to 0.17
0.11 ratio
Interval 0.08 to 0.14
0.09 ratio
Interval 0.06 to 0.13
0.11 ratio
Interval 0.08 to 0.15
0.12 ratio
Interval 0.09 to 0.15
0.18 ratio
Interval 0.14 to 0.23
0.13 ratio
Interval 0.1 to 0.17
0.18 ratio
Interval 0.16 to 0.21
0.26 ratio
Interval 0.22 to 0.3
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 271
0.13 ratio
Interval 0.1 to 0.15
0.15 ratio
Interval 0.13 to 0.18
0.14 ratio
Interval 0.11 to 0.17
0.16 ratio
Interval 0.14 to 0.2
0.16 ratio
Interval 0.14 to 0.19
0.17 ratio
Interval 0.12 to 0.23
0.19 ratio
Interval 0.15 to 0.23
0.18 ratio
Interval 0.14 to 0.23
0.15 ratio
Interval 0.12 to 0.2
0.15 ratio
Interval 0.12 to 0.2
0.16 ratio
Interval 0.12 to 0.21
0.18 ratio
Interval 0.14 to 0.21
0.16 ratio
Interval 0.1 to 0.25
0.17 ratio
Interval 0.14 to 0.21
0.19 ratio
Interval 0.17 to 0.21
0.23 ratio
Interval 0.2 to 0.27
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in One Dose Groups.
Day 366
0.14 ratio
Interval 0.11 to 0.18
0.20 ratio
Interval 0.17 to 0.25
0.18 ratio
Interval 0.15 to 0.22
0.20 ratio
Interval 0.17 to 0.24
0.15 ratio
Interval 0.12 to 0.19
0.18 ratio
Interval 0.13 to 0.24
0.18 ratio
Interval 0.14 to 0.23
0.18 ratio
Interval 0.13 to 0.23
0.17 ratio
Interval 0.12 to 0.23
0.16 ratio
Interval 0.13 to 0.21
0.17 ratio
Interval 0.12 to 0.24
0.15 ratio
Interval 0.12 to 0.19
0.16 ratio
Interval 0.09 to 0.26
0.16 ratio
Interval 0.13 to 0.2
0.21 ratio
Interval 0.19 to 0.24
0.24 ratio
Interval 0.21 to 0.28
—

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=86 Participants
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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;
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;
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;
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 1
0.04 ratio
Interval 0.03 to 0.05
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 15
0.06 ratio
95% confidence interval was not estimable as data from only 1 participant was analyzed
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 29
0.11 ratio
Interval 0.09 to 0.13
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 57
0.10 ratio
Interval 0.09 to 0.12
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 85
0.12 ratio
Interval 0.11 to 0.14
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 147
0.12 ratio
Interval 0.1 to 0.15
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 237
0.12 ratio
Interval 0.09 to 0.14
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 327
0.16 ratio
Interval 0.13 to 0.2
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
Geometric Mean Ratio (GMR) to D614G Variant of Pseudovirus Neutralization Against BA.4/BA.5 in Two Dose Group.
Day 422
0.15 ratio
Interval 0.12 to 0.2
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=86 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=101 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=99 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=99 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=50 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=52 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=54 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=51 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=52 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=53 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=51 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=52 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Frequency of Any Adverse Events (AEs) Leading to Withdrawal From the Study.
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=86 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=101 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=99 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=99 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=50 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=52 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=54 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=51 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=52 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=53 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=51 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=52 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Frequency of Any Adverse Events of Special Interest (AESIs)
3 Participants
7 Participants
7 Participants
5 Participants
3 Participants
1 Participants
0 Participants
0 Participants
1 Participants
1 Participants
1 Participants
0 Participants
2 Participants
2 Participants
2 Participants
1 Participants
2 Participants

SECONDARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=86 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=101 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=99 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=99 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=50 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=52 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=54 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=51 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=52 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=53 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=51 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=52 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Frequency of Any Medically Attended Adverse Events (MAAEs)
2 Participants
0 Participants
2 Participants
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=86 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=101 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=99 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=99 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=50 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=52 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=54 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=51 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=52 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=53 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=51 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=52 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Frequency of Any New Onset Chronic Medical Conditions (NOCMCs)
2 Participants
8 Participants
4 Participants
5 Participants
3 Participants
1 Participants
2 Participants
5 Participants
5 Participants
0 Participants
1 Participants
0 Participants
1 Participants
2 Participants
1 Participants
5 Participants
2 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=86 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=101 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=99 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=99 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=50 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=52 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=54 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=51 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=52 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=53 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=51 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=52 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Frequency of Any Serious Adverse Events (SAEs)
4 Participants
4 Participants
7 Participants
2 Participants
3 Participants
4 Participants
0 Participants
0 Participants
1 Participants
1 Participants
5 Participants
1 Participants
1 Participants
1 Participants
1 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=86 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=101 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=99 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=99 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=50 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=52 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=54 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=51 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=52 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=53 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=51 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=52 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)
82 Participants
88 Participants
70 Participants
80 Participants
81 Participants
80 Participants
40 Participants
42 Participants
37 Participants
33 Participants
36 Participants
39 Participants
33 Participants
33 Participants
35 Participants
80 Participants
83 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=86 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=101 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=99 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=99 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=50 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=52 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=54 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=51 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=52 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=53 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=51 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=52 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Frequency of Local Solicited Reactogenicity Adverse Events (AEs)
93 Participants
101 Participants
77 Participants
87 Participants
82 Participants
80 Participants
38 Participants
41 Participants
43 Participants
40 Participants
43 Participants
46 Participants
40 Participants
42 Participants
42 Participants
82 Participants
86 Participants

SECONDARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 Participants
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=113 Participants
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=86 Participants
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=101 Participants
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=99 Participants
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=99 Participants
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=50 Participants
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=52 Participants
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=54 Participants
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=51 Participants
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=52 Participants
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=53 Participants
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=49 Participants
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=51 Participants
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=52 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 Participants
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;
Frequency of Any Unsolicited Adverse Events (AEs)
26 Participants
40 Participants
39 Participants
31 Participants
35 Participants
33 Participants
17 Participants
12 Participants
14 Participants
13 Participants
19 Participants
16 Participants
15 Participants
13 Participants
11 Participants
33 Participants
28 Participants

Adverse Events

Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)

Serious events: 4 serious events
Other events: 98 other events
Deaths: 0 deaths

Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)

Serious events: 4 serious events
Other events: 185 other events
Deaths: 0 deaths

Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses)

Serious events: 6 serious events
Other events: 76 other events
Deaths: 0 deaths

Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)

Serious events: 2 serious events
Other events: 98 other events
Deaths: 0 deaths

Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)

Serious events: 3 serious events
Other events: 94 other events
Deaths: 0 deaths

Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)

Serious events: 2 serious events
Other events: 89 other events
Deaths: 1 deaths

Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])

Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths

Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)

Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths

Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)

Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths

Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)

Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths

Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])

Serious events: 5 serious events
Other events: 48 other events
Deaths: 0 deaths

Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])

Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths

Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)

Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths

Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)

Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths

Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)

Serious events: 1 serious events
Other events: 49 other events
Deaths: 1 deaths

Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])

Serious events: 0 serious events
Other events: 96 other events
Deaths: 0 deaths

Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])

Serious events: 0 serious events
Other events: 94 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 participants at risk
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=199 participants at risk
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)
Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses)
n=86 participants at risk
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 participants at risk
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 participants at risk
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=99 participants at risk
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=50 participants at risk
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 participants at risk
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 participants at risk
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 participants at risk
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 participants at risk
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 participants at risk
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=49 participants at risk
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=51 participants at risk
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 participants at risk
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=101 participants at risk
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 participants at risk
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;
Gastrointestinal disorders
Small bowel obstruction
1.0%
1/99 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Infections and infestations
Right upper lobe pneumonia
1.0%
1/99 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Nervous system disorders
Intracranial hemorrhage
1.0%
1/99 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Metabolism and nutrition disorders
Dehydration
1.0%
1/99 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Respiratory, thoracic and mediastinal disorders
Acute exacerbation of COPD
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.50%
1/199 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Psychiatric disorders
Alcohol use disorder
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.50%
1/199 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Vascular disorders
Orthostatic hypotension
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.50%
1/199 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Vascular disorders
Worsening orthostatic hypotension
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.50%
1/199 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Infections and infestations
Urinary tract infection
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.50%
1/199 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Injury, poisoning and procedural complications
Traumatic lisfranc injury to right foot
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.50%
1/199 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.50%
1/199 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Respiratory, thoracic and mediastinal disorders
Shortness of breath
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.50%
1/199 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Nervous system disorders
Right parietal hemorrhage stroke
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.2%
1/86 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Infections and infestations
Appendicitis
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.2%
1/86 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Gastrointestinal disorders
Perforated duodenal ulcer
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.2%
1/86 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Vascular disorders
Giant cell arteritis
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.2%
1/86 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Nervous system disorders
Stroke
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.2%
1/86 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Injury, poisoning and procedural complications
Head injury
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.2%
1/86 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Pregnancy, puerperium and perinatal conditions
Vasa previa
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.2%
1/86 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Hepatobiliary disorders
Acute cholecystitis
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.99%
1/101 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Cardiac disorders
Supraventricular tachycardia
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.99%
1/101 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Skin and subcutaneous tissue disorders
Angioedema
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.0%
1/99 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Respiratory, thoracic and mediastinal disorders
Acute hypoxic respiratory failure
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.0%
1/99 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.0%
1/99 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Cardiac disorders
Cardiac arrest
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.0%
1/99 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Infections and infestations
Great toe cellulitis
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.0%
1/99 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Blood and lymphatic system disorders
Sickle cell crisis
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/54 • Number of events 2 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Infections and infestations
Pyelonephritis
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/54 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Gastrointestinal disorders
Non reducible hemorrhoid
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/54 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Infections and infestations
Pneumonia
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/54 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Musculoskeletal and connective tissue disorders
Diastasis recti
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
2.0%
1/51 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Musculoskeletal and connective tissue disorders
Chest wall pain
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Reoccurring appendiceal cancer
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Reproductive system and breast disorders
Enlargement of ovarian cysts
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Nervous system disorders
Seizure
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Renal and urinary disorders
Clot retention in the urinary bladder
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Gastrointestinal disorders
Bleeding stomach ulcer
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/53 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Cardiac disorders
Atrial fibrillation
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
2.0%
1/49 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease exacerbation
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
2.0%
1/51 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Infections and infestations
Acute COVID19 multifocal pneumonia
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ascending colon adenocarcinoma
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Gastrointestinal disorders
Gastrointestinal bleeding
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Gastrointestinal disorders
Diarrhea
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.

Other adverse events

Other adverse events
Measure
Stage 1 - Arm 01 (Moderna mRNA1273 Prototype)
n=99 participants at risk
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)
Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose)
n=199 participants at risk
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)
Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses)
n=86 participants at risk
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)
Stage 1 - Arm 04 (Moderna mRNA1273 Delta + Omicron)
n=101 participants at risk
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)
Stage 1 - Arm 05 (Moderna mRNA1273 Omicron)
n=99 participants at risk
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)
Stage 1 - Arm 06 (Moderna mRNA1273 Omicron + Prototype)
n=99 participants at risk
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)
Stage 2 - Arm 07 (Pfizer/BNT BNT162b2 Wildtype [Prototype])
n=50 participants at risk
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)
Stage 2 - Arm 08 (Pfizer/BNT BNT162b2 Beta + Omicron)
n=52 participants at risk
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)
Stage 2 - Arm 09 (Pfizer/BNT BNT162b2 Omicron)
n=54 participants at risk
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)
Stage 2 - Arm 10 (Pfizer/BNT BNT162b2 Beta)
n=51 participants at risk
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)
Stage 2 - Arm 11 (Pfizer/BNT BNT162b2 Beta + Wildtype [Prototype])
n=52 participants at risk
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)
Stage 2 - Arm 12 (Pfizer/BNT BNT162b2 Omicron + Wildtype [Prototype])
n=53 participants at risk
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)
Stage 3 - Arm 13 (Sanofi CoV2 preS dTM-AS03 Prototype)
n=49 participants at risk
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)
Stage 3 - Arm 14 (Sanofi CoV2 preS dTM-AS03 Beta)
n=51 participants at risk
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)
Stage 3 - Arm 15 (Sanofi CoV2 preS dTM-AS03 Beta + Prototype)
n=52 participants at risk
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)
Stage 4 - Arm 16 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.1 + Wildtype [Prototype])
n=101 participants at risk
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;
Stage 4 - Arm 17 (Pfizer/BNT BNT162b2 Bivalent Omicron BA.4/BA.5 + Wildtype [Prototype])
n=101 participants at risk
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;
Nervous system disorders
Headache
33.3%
33/99 • Number of events 33 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
43.2%
86/199 • Number of events 86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
31.4%
27/86 • Number of events 27 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
42.6%
43/101 • Number of events 43 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
39.4%
39/99 • Number of events 39 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
48.5%
48/99 • Number of events 48 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
52.0%
26/50 • Number of events 26 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
32.7%
17/52 • Number of events 17 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
37.0%
20/54 • Number of events 20 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
45.1%
23/51 • Number of events 23 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
36.5%
19/52 • Number of events 19 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
35.8%
19/53 • Number of events 19 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
44.9%
22/49 • Number of events 22 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
33.3%
17/51 • Number of events 17 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
26.9%
14/52 • Number of events 14 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
44.6%
45/101 • Number of events 45 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
41.6%
42/101 • Number of events 42 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
4.0%
2/50 • Number of events 2 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
5.6%
3/54 • Number of events 3 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
3.9%
2/51 • Number of events 2 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/52 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
3.8%
2/53 • Number of events 2 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Gastrointestinal disorders
Diarrhoea
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
4.0%
2/50 • Number of events 2 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
3.8%
2/52 • Number of events 2 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/54 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
5.9%
3/51 • Number of events 3 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Infections and infestations
Upper respiratory tract infection
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/199 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/86 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/101 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/99 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/50 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/54 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
5.0%
5/101 • Number of events 5 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
7.9%
8/101 • Number of events 9 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Gastrointestinal disorders
Nausea
11.1%
11/99 • Number of events 11 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
18.1%
36/199 • Number of events 36 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
11.6%
10/86 • Number of events 10 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
9.9%
10/101 • Number of events 10 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
10.1%
10/99 • Number of events 10 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
28.3%
28/99 • Number of events 28 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
16.0%
8/50 • Number of events 8 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
11.5%
6/52 • Number of events 6 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
13.0%
7/54 • Number of events 7 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
13.7%
7/51 • Number of events 7 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
13.5%
7/52 • Number of events 7 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
1.9%
1/53 • Number of events 1 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
12.2%
6/49 • Number of events 6 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
9.8%
5/51 • Number of events 5 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
7.7%
4/52 • Number of events 4 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
14.9%
15/101 • Number of events 15 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
15.8%
16/101 • Number of events 16 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
General disorders
Chills
32.3%
32/99 • Number of events 32 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
25.6%
51/199 • Number of events 51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
19.8%
17/86 • Number of events 17 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
32.7%
33/101 • Number of events 33 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
29.3%
29/99 • Number of events 29 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
33.3%
33/99 • Number of events 33 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
16.0%
8/50 • Number of events 8 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
13.5%
7/52 • Number of events 7 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
20.4%
11/54 • Number of events 11 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
21.6%
11/51 • Number of events 11 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
17.3%
9/52 • Number of events 9 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
13.2%
7/53 • Number of events 7 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
18.4%
9/49 • Number of events 9 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
13.7%
7/51 • Number of events 7 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
17.3%
9/52 • Number of events 9 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
21.8%
22/101 • Number of events 22 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
33.7%
34/101 • Number of events 34 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
General disorders
Fatigue
66.7%
66/99 • Number of events 66 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
64.3%
128/199 • Number of events 128 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
50.0%
43/86 • Number of events 43 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
67.3%
68/101 • Number of events 68 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
67.7%
67/99 • Number of events 67 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
71.7%
71/99 • Number of events 71 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
74.0%
37/50 • Number of events 37 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
61.5%
32/52 • Number of events 32 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
48.1%
26/54 • Number of events 26 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
56.9%
29/51 • Number of events 29 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
59.6%
31/52 • Number of events 31 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
58.5%
31/53 • Number of events 31 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
51.0%
25/49 • Number of events 25 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
45.1%
23/51 • Number of events 23 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
55.8%
29/52 • Number of events 29 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
64.4%
65/101 • Number of events 65 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
73.3%
74/101 • Number of events 74 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
General disorders
Pyrexia
5.1%
5/99 • Number of events 5 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
7.0%
14/199 • Number of events 14 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
3.5%
3/86 • Number of events 3 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
12.9%
13/101 • Number of events 13 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
6.1%
6/99 • Number of events 6 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
12.1%
12/99 • Number of events 12 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
6.0%
3/50 • Number of events 3 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
5.8%
3/52 • Number of events 3 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
3.7%
2/54 • Number of events 2 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
5.9%
3/51 • Number of events 3 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
5.8%
3/52 • Number of events 3 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
3.8%
2/53 • Number of events 2 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
0.00%
0/52 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
7.9%
8/101 • Number of events 8 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
6.9%
7/101 • Number of events 7 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
General disorders
Vaccination site induration
21.2%
21/99 • Number of events 21 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
26.6%
53/199 • Number of events 53 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
27.9%
24/86 • Number of events 24 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
19.8%
20/101 • Number of events 20 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
17.2%
17/99 • Number of events 17 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
20.2%
20/99 • Number of events 20 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
20.0%
10/50 • Number of events 10 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
9.6%
5/52 • Number of events 5 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
20.4%
11/54 • Number of events 11 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
23.5%
12/51 • Number of events 12 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
17.3%
9/52 • Number of events 9 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
20.8%
11/53 • Number of events 11 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
34.7%
17/49 • Number of events 17 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
21.6%
11/51 • Number of events 11 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
25.0%
13/52 • Number of events 13 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
18.8%
19/101 • Number of events 19 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
22.8%
23/101 • Number of events 23 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
General disorders
Vaccination site pain
89.9%
89/99 • Number of events 89 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
84.4%
168/199 • Number of events 168 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
73.3%
63/86 • Number of events 63 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
82.2%
83/101 • Number of events 83 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
82.8%
82/99 • Number of events 82 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
76.8%
76/99 • Number of events 76 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
72.0%
36/50 • Number of events 36 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
76.9%
40/52 • Number of events 40 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
77.8%
42/54 • Number of events 42 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
74.5%
38/51 • Number of events 38 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
80.8%
42/52 • Number of events 42 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
83.0%
44/53 • Number of events 44 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
77.6%
38/49 • Number of events 38 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
72.5%
37/51 • Number of events 37 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
76.9%
40/52 • Number of events 40 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
80.2%
81/101 • Number of events 81 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
83.2%
84/101 • Number of events 84 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Musculoskeletal and connective tissue disorders
Arthralgia
24.2%
24/99 • Number of events 24 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
24.6%
49/199 • Number of events 49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
10.5%
9/86 • Number of events 9 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
25.7%
26/101 • Number of events 26 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
24.2%
24/99 • Number of events 24 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
24.2%
24/99 • Number of events 24 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
20.0%
10/50 • Number of events 10 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
30.8%
16/52 • Number of events 16 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
22.2%
12/54 • Number of events 12 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
19.6%
10/51 • Number of events 10 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
21.2%
11/52 • Number of events 11 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
13.2%
7/53 • Number of events 7 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
12.2%
6/49 • Number of events 6 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
11.8%
6/51 • Number of events 6 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
11.5%
6/52 • Number of events 6 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
19.8%
20/101 • Number of events 20 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
25.7%
26/101 • Number of events 26 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
Musculoskeletal and connective tissue disorders
Myalgia
67.7%
67/99 • Number of events 67 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
52.8%
105/199 • Number of events 105 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
45.3%
39/86 • Number of events 39 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
48.5%
49/101 • Number of events 49 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
60.6%
60/99 • Number of events 60 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
64.6%
64/99 • Number of events 64 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
56.0%
28/50 • Number of events 28 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
57.7%
30/52 • Number of events 30 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
42.6%
23/54 • Number of events 23 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
45.1%
23/51 • Number of events 23 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
46.2%
24/52 • Number of events 24 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
47.2%
25/53 • Number of events 25 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
38.8%
19/49 • Number of events 19 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
39.2%
20/51 • Number of events 20 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
42.3%
22/52 • Number of events 22 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
50.5%
51/101 • Number of events 51 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.
58.4%
59/101 • Number of events 59 • Solicited AEs (i.e., reactogenicity) will be collected using a memory aid from the time of each vaccination through 7 days post each vaccination. Unsolicited AEs of all severities will be reported from the time of study product administration through 28 days post each vaccination. After 28 days post vaccination through Day 366 (Arms 1,2,4,5,6,7,8,9,10,11,12,13,14,15,16,17) or Day 422 (Arm 3) only AESIs/MAAEs/SAEs/NOCMCs and AEs leading to withdrawal were reported as AEs.
Participants in Stage 1 - Arm 03 (Moderna mRNA 1273 Beta + Omicron - 2 Doses) were included in Stage 1 - Arm 02 (Moderna mRNA 1273 Beta + Omicron - 1 Dose) for reporting AEs that occurred after Dose 1 but before Dose 2.

Additional Information

Nadine Rouphael, MD

The Hope Clinic of Emory University

Phone: 404-712-1435

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60