Trial Outcomes & Findings for A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults (NCT NCT05037097)

Last Updated: 2025-10-15

Results Overview

Solicited local AEs were defined as injection site erythema, injection site pain, injection site induration, and injection site tenderness. Solicited systemic AEs were defined as arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, nausea and vomiting. Data are reported for the number of participants with solicited local and solicited systemic AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

72 participants

Primary outcome timeframe

Up to Day 8 (7 days after first vaccine administration for Cohorts A1, A2 and B), and up to Day 36 (7 days after second vaccine administration for Cohorts A1 and A2)

Results posted on

2025-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A1: ARCT-021 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Overall Study STARTED	4	4	4	6	18	12	12	12
Overall Study Received at Least 1 Dose of Study Drug	4	4	4	6	18	12	12	12
Overall Study COMPLETED	4	2	4	5	17	9	12	12
Overall Study NOT COMPLETED	0	2	0	1	1	3	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A1: ARCT-021 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Overall Study Withdrawal by Subject	0	1	0	1	0	2	0	0
Overall Study Lost to Follow-up	0	1	0	0	1	1	0	0

Baseline Characteristics

A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=18 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Total n=72 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 17 • n=5 Participants	34 years STANDARD_DEVIATION 10 • n=7 Participants	50 years STANDARD_DEVIATION 17 • n=5 Participants	33 years STANDARD_DEVIATION 9 • n=4 Participants	31 years STANDARD_DEVIATION 8 • n=21 Participants	44 years STANDARD_DEVIATION 16 • n=10 Participants	50 years STANDARD_DEVIATION 13 • n=115 Participants	44 years STANDARD_DEVIATION 13 • n=6 Participants	41 years STANDARD_DEVIATION 14 • n=6 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants	9 Participants n=10 Participants	6 Participants n=115 Participants	7 Participants n=6 Participants	42 Participants n=6 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants	3 Participants n=10 Participants	6 Participants n=115 Participants	5 Participants n=6 Participants	30 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	3 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	17 Participants n=21 Participants	10 Participants n=10 Participants	12 Participants n=115 Participants	12 Participants n=6 Participants	69 Participants n=6 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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=6 Participants	10 Participants n=6 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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	16 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=6 Participants	27 Participants n=6 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	9 Participants n=10 Participants	8 Participants n=115 Participants	10 Participants n=6 Participants	33 Participants n=6 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants
Race (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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: Up to Day 8 (7 days after first vaccine administration for Cohorts A1, A2 and B), and up to Day 36 (7 days after second vaccine administration for Cohorts A1 and A2)

Population: Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received. Number analyzed for Cohort B arms for AEs after Dose 2 = 0 as participants in this Cohort received only a single dose of treatment.

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=18 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) Any Solicited Local AE After Dose 1	3 Participants	4 Participants	3 Participants	5 Participants	10 Participants	12 Participants	10 Participants	10 Participants
Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) Any Solicited Local AE After Dose 2	2 Participants	2 Participants	4 Participants	6 Participants	10 Participants	—	—	—
Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) Any Solicited Systemic AE After Dose 1	3 Participants	3 Participants	1 Participants	5 Participants	9 Participants	12 Participants	9 Participants	11 Participants
Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs) Any Solicited Systemic AE After Dose 2	2 Participants	2 Participants	3 Participants	5 Participants	10 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to Day 29 (28 days after vaccine administration for Cohort B), and up to Day 57 (up to 28 days after each vaccine administration for Cohorts A1 and A2)

Unsolicited AEs were defined as any spontaneously reported or discovered AE. Data are reported for the number of participants with unsolicited AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=18 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Number of Participants Reporting Unsolicited AEs	3 Participants	3 Participants	2 Participants	4 Participants	15 Participants	9 Participants	9 Participants	10 Participants

PRIMARY outcome

Timeframe: Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days

An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) with a health care provider (HCP) (e.g., nurse, nurse practitioner, physician's assistant, physician), including visits to a study site for unscheduled assessments (e.g., rash assessment, abnormal laboratory follow up, coronavirus disease 2019 \[COVID-19\]) and visits to HCPs external to the study site (e.g., urgent care, primary care physician). An SAE was defined as any event that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=18 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) Any MAAEs	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants	2 Participants	1 Participants	0 Participants
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) Any AEs Leading to Discontinuation from Study Vaccine/Study Withdrawal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs) Any SAEs	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2; Baseline, Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B

Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.

Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral D614G variant. Data are reported in international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=3 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=18 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) Pseudoviral D614G; Baseline	8 IU/mL Confidence interval data were non-estimable because baseline values were below the limit of quantification for all participants in the arm.	8 IU/mL Interval 6.0 to 11.0	12 IU/mL Interval 4.0 to 33.0	421 IU/mL Interval 74.0 to 2383.0	455 IU/mL Interval 202.0 to 1028.0	87 IU/mL Interval 51.0 to 148.0	94 IU/mL Interval 29.0 to 301.0	114 IU/mL Interval 58.0 to 224.0
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) Pseudoviral D614G; Day 15	—	—	—	—	—	1415 IU/mL Interval 927.0 to 2160.0	2019 IU/mL Interval 1179.0 to 3459.0	3474 IU/mL Interval 1577.0 to 7656.0
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) Pseudoviral D614G; Day 29	36 IU/mL Interval 0.0 to 2715.0	9 IU/mL Interval 2.0 to 47.0	26 IU/mL Interval 6.0 to 107.0	1966 IU/mL Interval 592.0 to 6534.0	1949 IU/mL Interval 1026.0 to 3701.0	1741 IU/mL Interval 1001.0 to 3028.0	2202 IU/mL Interval 1170.0 to 4145.0	4200 IU/mL Interval 2274.0 to 7757.0
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) Pseudoviral D614G; Day 57	42 IU/mL Interval 2.0 to 998.0	87 IU/mL Interval 0.0 to 1334270362.0	70 IU/mL Interval 11.0 to 452.0	2038 IU/mL Interval 676.0 to 6143.0	3563 IU/mL Interval 2083.0 to 6096.0	—	—	—
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) Pseudoviral D614G; Day 91	—	—	—	—	—	1796 IU/mL Interval 1067.0 to 3024.0	1697 IU/mL Interval 840.0 to 3429.0	3427 IU/mL Interval 2113.0 to 5558.0
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) Pseudoviral D614G; Day 181	—	—	—	—	—	1072 IU/mL Interval 450.0 to 2551.0	1534 IU/mL Interval 552.0 to 4260.0	3041 IU/mL Interval 1334.0 to 6932.0
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) Pseudoviral D614G; Day 209	90 IU/mL Interval 2.0 to 3976.0	—	19 IU/mL Interval 4.0 to 85.0	1340 IU/mL Interval 100.0 to 17882.0	1402 IU/mL Interval 819.0 to 2402.0	—	—	—
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) Pseudoviral D614G; Day 271	—	—	—	—	—	611 IU/mL Interval 246.0 to 1518.0	2158 IU/mL Interval 1198.0 to 3888.0	1965 IU/mL Interval 789.0 to 4893.0
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) Pseudoviral D614G; Final Visit Cohort B (approx. Day 366)	—	—	—	—	—	564 IU/mL Interval 232.0 to 1370.0	1924 IU/mL Interval 374.0 to 9900.0	2463 IU/mL Interval 870.0 to 6976.0
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC) Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394)	60 IU/mL Interval 2.0 to 2088.0	—	14 IU/mL Interval 0.0 to 3129.0	1000 IU/mL Interval 10.0 to 100036.0	1324 IU/mL Interval 671.0 to 2609.0	—	—	—

PRIMARY outcome

Timeframe: Baseline, Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2; Baseline, Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B

Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral B.1.351 (beta) variant. Data are reported in arbitrary units per milliliter (AU/mL).

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=3 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=18 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC Pseudoviral B.1.351 (Beta); Baseline	14 AU/mL Confidence interval data were non-estimable because baseline values were below the limit of quantification for all participants in the arm.	14 AU/mL Confidence interval data were non-estimable because baseline values were below the limit of quantification for all participants in the arm.	14 AU/mL Interval 13.0 to 15.0	402 AU/mL Interval 92.0 to 1761.0	442 AU/mL Interval 187.0 to 1042.0	38 AU/mL Interval 21.0 to 70.0	44 AU/mL Interval 15.0 to 130.0	60 AU/mL Interval 31.0 to 117.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC Pseudoviral B.1.351 (Beta); Day 15	—	—	—	—	—	554 AU/mL Interval 370.0 to 829.0	1479 AU/mL Interval 824.0 to 2652.0	1692 AU/mL Interval 905.0 to 3162.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC Pseudoviral B.1.351 (Beta); Day 29	17 AU/mL Interval 7.0 to 45.0	32 AU/mL Interval 0.0 to 1385422.0	17 AU/mL Interval 12.0 to 24.0	1926 AU/mL Interval 788.0 to 4710.0	1273 AU/mL Interval 615.0 to 2634.0	664 AU/mL Interval 447.0 to 986.0	1608 AU/mL Interval 940.0 to 2749.0	1768 AU/mL Interval 1061.0 to 2948.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC Pseudoviral B.1.351 (Beta); Day 57	21 AU/mL Interval 6.0 to 75.0	452 AU/mL Interval 0.0 to 1024516559.0	27 AU/mL Interval 10.0 to 71.0	2292 AU/mL Interval 991.0 to 5300.0	3237 AU/mL Interval 2123.0 to 4936.0	—	—	—
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC Pseudoviral B.1.351 (Beta); Day 91	—	—	—	—	—	560 AU/mL Interval 326.0 to 960.0	1079 AU/mL Interval 559.0 to 2083.0	1376 AU/mL Interval 838.0 to 2260.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC Pseudoviral B.1.351 (Beta); Day 181	—	—	—	—	—	400 AU/mL Interval 142.0 to 1126.0	708 AU/mL Interval 219.0 to 2293.0	1202 AU/mL Interval 512.0 to 2819.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC Pseudoviral B.1.351 (Beta); Day 209	97 AU/mL Interval 3.0 to 3668.0	—	14 AU/mL Interval 13.0 to 16.0	1372 AU/mL Interval 185.0 to 10163.0	1438 AU/mL Interval 780.0 to 2652.0	—	—	—
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC Pseudoviral B.1.351 (Beta); Day 271	—	—	—	—	—	175 AU/mL Interval 30.0 to 1036.0	829 AU/mL Interval 252.0 to 2724.0	1129 AU/mL Interval 446.0 to 2858.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366)	—	—	—	—	—	213 AU/mL Interval 60.0 to 763.0	1532 AU/mL Interval 389.0 to 6036.0	1578 AU/mL Interval 604.0 to 4122.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC Pseudoviral B.1.351 (Beta); Final Visit Cohort A1 and A2 (approx. Day 394)	61 AU/mL Interval 3.0 to 1082.0	—	14 AU/mL Confidence interval data were non-estimable because values were below the limit of quantification for all participants in the arm.	1502 AU/mL Interval 45.0 to 50296.0	847 AU/mL Interval 467.0 to 1535.0	—	—	—

PRIMARY outcome

Timeframe: Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B

Blood samples were collected to assess participants' immune response. GMFR data are reported for the pseudoviral D614G variant.

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=2 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=17 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) Pseudoviral D614G; Day 15	—	—	—	—	—	16 ratio Interval 9.0 to 30.0	22 ratio Interval 9.0 to 50.0	28 ratio Interval 11.0 to 67.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) Pseudoviral D614G; Day 29	4.6 ratio Interval 0.1 to 346.2	1.0 ratio Interval 0.6 to 1.7	2.2 ratio Interval 0.4 to 12.2	4.7 ratio Interval 1.4 to 15.9	4.4 ratio Interval 2.7 to 7.0	20 ratio Interval 10.0 to 41.0	24 ratio Interval 10.0 to 54.0	37 ratio Interval 17.0 to 77.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) Pseudoviral D614G; Day 57	5.4 ratio Interval 0.2 to 127.2	10.1 ratio Interval 0.0 to 48765966.9	5.9 ratio Interval 0.5 to 65.0	4.8 ratio Interval 1.2 to 19.0	6.2 ratio Interval 3.8 to 10.0	—	—	—
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) Pseudoviral D614G; Day 91	—	—	—	—	—	20 ratio Interval 10.0 to 41.0	17 ratio Interval 8.0 to 36.0	30 ratio Interval 19.0 to 47.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) Pseudoviral D614G; Day 181	—	—	—	—	—	11 ratio Interval 4.0 to 30.0	12 ratio Interval 3.0 to 45.0	31 ratio Interval 14.0 to 70.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) Pseudoviral D614G; Day 209	11.4 ratio Interval 0.3 to 506.9	—	1.4 ratio Interval 0.1 to 14.7	3.2 ratio Interval 0.7 to 14.2	2.7 ratio Interval 1.8 to 4.1	—	—	—
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) Pseudoviral D614G; Day 271	—	—	—	—	—	5 ratio Interval 1.0 to 19.0	13 ratio Interval 2.0 to 71.0	20 ratio Interval 10.0 to 43.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) Pseudoviral D614G; Final Visit Cohort B (approx. Day 366)	—	—	—	—	—	6 ratio Interval 1.0 to 27.0	27 ratio Interval 5.0 to 147.0	25 ratio Interval 7.0 to 88.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR) Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394)	7.7 ratio Interval 0.2 to 266.2	—	0.8 ratio Interval 0.0 to 329524.9	2.7 ratio Interval 0.2 to 42.6	1.9 ratio Interval 1.1 to 3.3	—	—	—

PRIMARY outcome

Timeframe: Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B

Blood samples were collected to assess participants' immune response. GMFR data are reported for the pseudoviral B.1.351 (beta) variant.

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=2 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=17 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR Pseudoviral B.1.351 (Beta); Day 15	—	—	—	—	—	14 ratio Interval 8.0 to 26.0	34 ratio Interval 16.0 to 72.0	25 ratio Interval 12.0 to 51.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR Pseudoviral B.1.351 (Beta); Day 29	1.2 ratio Interval 0.5 to 3.2	2.3 ratio Interval 0.0 to 98958.7	1.2 ratio Interval 0.8 to 1.7	4.8 ratio Interval 1.6 to 14.0	3.2 ratio Interval 1.3 to 7.5	17 ratio Interval 10.0 to 31.0	37 ratio Interval 17.0 to 77.0	29 ratio Interval 16.0 to 54.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR Pseudoviral B.1.351 (Beta); Day 57	1.5 ratio Interval 0.4 to 5.4	32.3 ratio Interval 0.0 to 73179754.2	1.9 ratio Interval 0.7 to 4.9	5.7 ratio Interval 1.4 to 22.7	5.6 ratio Interval 3.3 to 9.7	—	—	—
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR Pseudoviral B.1.351 (Beta); Day 91	—	—	—	—	—	14 ratio Interval 7.0 to 27.0	23 ratio Interval 10.0 to 51.0	23 ratio Interval 15.0 to 35.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR Pseudoviral B.1.351 (Beta); Day 181	—	—	—	—	—	10 ratio Interval 4.0 to 26.0	12 ratio Interval 1.0 to 98.0	24 ratio Interval 10.0 to 56.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR Pseudoviral B.1.351 (Beta); Day 209	6.9 ratio Interval 0.2 to 262.0	—	1.0 ratio Confidence interval data were non-estimable because values were below the limit of quantification for all participants in the arm.	2.8 ratio Interval 0.7 to 11.6	2.9 ratio Interval 1.8 to 4.6	—	—	—
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR Pseudoviral B.1.351 (Beta); Day 271	—	—	—	—	—	4 ratio Interval 2.0 to 8.0	12 ratio Interval 2.0 to 71.0	23 ratio Interval 11.0 to 45.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366)	—	—	—	—	—	5 ratio Interval 1.0 to 22.0	46 ratio Interval 5.0 to 409.0	31 ratio Interval 9.0 to 108.0
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR Pseudoviral B.1.351 (Beta); Final Visit Cohorts A1 and A2 (approx. Day 394)	4.4 ratio Interval 0.2 to 77.3	—	1.0 ratio Interval 0.6 to 1.5	3.0 ratio Interval 0.2 to 42.9	1.7 ratio Interval 0.9 to 3.2	—	—	—

PRIMARY outcome

Timeframe: Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B

Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G variant.

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=2 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=17 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) Pseudoviral D614G; Day 15	—	—	—	—	—	11 Participants	11 Participants	10 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) Pseudoviral D614G; Day 29	1 Participants	0 Participants	2 Participants	3 Participants	10 Participants	11 Participants	11 Participants	11 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) Pseudoviral D614G; Day 57	2 Participants	1 Participants	2 Participants	4 Participants	11 Participants	—	—	—
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) Pseudoviral D614G; Day 91	—	—	—	—	—	10 Participants	10 Participants	12 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) Pseudoviral D614G; Day 181	—	—	—	—	—	5 Participants	8 Participants	9 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) Pseudoviral D614G; Day 209	2 Participants	—	0 Participants	1 Participants	5 Participants	—	—	—
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) Pseudoviral D614G; Day 271	—	—	—	—	—	3 Participants	6 Participants	8 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) Pseudoviral D614G; Final Visit Cohort B (approx. Day 366)	—	—	—	—	—	3 Participants	5 Participants	6 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant) Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394)	2 Participants	—	0 Participants	1 Participants	1 Participants	—	—	—

PRIMARY outcome

Timeframe: Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B

Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral B.1.351 (beta) variant.

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=2 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=17 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) Pseudoviral B.1.351 (Beta); Day 15	—	—	—	—	—	11 Participants	11 Participants	10 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) Pseudoviral B.1.351 (Beta); Day 29	0 Participants	1 Participants	0 Participants	3 Participants	9 Participants	11 Participants	11 Participants	11 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) Pseudoviral B.1.351 (Beta); Day 57	1 Participants	2 Participants	1 Participants	3 Participants	9 Participants	—	—	—
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) Pseudoviral B.1.351 (Beta); Day 91	—	—	—	—	—	9 Participants	10 Participants	12 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) Pseudoviral B.1.351 (Beta); Day 181	—	—	—	—	—	4 Participants	8 Participants	8 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) Pseudoviral B.1.351 (Beta); Day 209	2 Participants	—	0 Participants	1 Participants	5 Participants	—	—	—
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) Pseudoviral B.1.351 (Beta); Day 271	—	—	—	—	—	2 Participants	5 Participants	9 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366)	—	—	—	—	—	3 Participants	4 Participants	7 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant) Pseudoviral B.1.351 (Beta); Final Visit Cohorts A1 and A2 (approx. Day 394)	2 Participants	—	0 Participants	1 Participants	1 Participants	—	—	—

PRIMARY outcome

Timeframe: Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B

Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G Variant, B.1.351 Variant, B.1.617.2 Variant, BA.1 Variant for the GMC ratio of ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154. Data are reported for the ARCT-165 and ARCT-021 arms (vs ARCT-154 values).

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=2 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=12 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.617.2; Final Visit Cohorts A1 and A2 (approx. Day 394)	2.18 ratio Interval 0.317 to 15.035	—	0.84 ratio Interval 0.179 to 3.905	—	—	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.617.2; Final Visit Cohort B (approx. Day 366)	—	—	—	0.35 ratio Interval 0.095 to 1.282	1.30 ratio Interval 0.279 to 6.1	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral BA.1 Variant; Day 15	—	—	—	0.34 ratio Interval 0.159 to 0.74	1.18 ratio Interval 0.501 to 2.799	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral BA.1 Variant; Day 29	1.52 ratio Interval 0.677 to 3.427	1.05 ratio Interval 0.832 to 1.336	1.18 ratio Interval 0.369 to 3.76	0.36 ratio Interval 0.182 to 0.703	1.06 ratio Interval 0.485 to 2.31	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral BA.1 Variant; Day 57	1.15 ratio Interval 0.612 to 2.153	9.73 ratio Interval 0.286 to 331.151	0.74 ratio Interval 0.287 to 1.913	—	—	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral BA.1 Variant; Day 91	—	—	—	0.35 ratio Interval 0.182 to 0.666	0.82 ratio Interval 0.361 to 1.856	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral BA.1 Variant; Day 181	—	—	—	0.22 ratio Interval 0.047 to 1.032	0.82 ratio Interval 0.194 to 3.479	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral BA.1 Variant; Day 209	8.15 ratio Interval 0.701 to 94.646	—	1.38 ratio Interval 0.26 to 7.365	—	—	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral BA.1 Variant; Day 271	—	—	—	0.20 ratio Interval 0.038 to 1.011	1.27 ratio Interval 0.369 to 4.347	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral BA.1 Variant; Final Visit Cohorts A1 and A2 (approx. Day 394)	3.69 ratio Interval 0.19 to 71.73	—	1.91 ratio Interval 0.223 to 16.385	—	—	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral BA.1 Variant; Final Visit Cohort B (approx. Day 366)	—	—	—	0.11 ratio Interval 0.02 to 0.562	0.87 ratio Interval 0.162 to 4.62	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral D614G; Day 15	—	—	—	0.41 ratio Interval 0.179 to 0.924	0.58 ratio Interval 0.24 to 1.405	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral D614G; Day 29	1.38 ratio Interval 0.108 to 17.701	0.35 ratio Interval 0.054 to 2.225	1.01 ratio Interval 0.301 to 3.377	0.41 ratio Interval 0.19 to 0.903	0.52 ratio Interval 0.229 to 1.203	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral D614G; Day 57	0.60 ratio Interval 0.035 to 10.082	1.23 ratio Interval 0.046 to 33.164	0.57 ratio Interval 0.21 to 1.559	—	—	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral D614G; Day 91	—	—	—	0.52 ratio Interval 0.269 to 1.021	0.50 ratio Interval 0.225 to 1.089	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral D614G; Day 181	—	—	—	0.35 ratio Interval 0.115 to 1.082	0.50 ratio Interval 0.151 to 1.686	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral D614G; Day 209	4.65 ratio Interval 0.115 to 188.134	—	0.96 ratio Interval 0.251 to 3.629	—	—	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral D614G; Day 271	—	—	—	0.31 ratio Interval 0.086 to 1.123	1.10 ratio Interval 0.377 to 3.199	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394)	4.20 ratio Interval 0.038 to 458.249	—	0.76 ratio Interval 0.139 to 4.106	—	—	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral D614G; Final Visit Cohort B (approx. Day 366)	—	—	—	0.23 ratio Interval 0.064 to 0.825	0.78 ratio Interval 0.162 to 3.771	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.351; Day 15	—	—	—	0.33 ratio Interval 0.165 to 0.65	0.87 ratio Interval 0.392 to 1.951	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.351; Day 29	1.03 ratio Interval 0.575 to 1.846	1.92 ratio Interval 0.426 to 8.609	1.51 ratio Interval 0.418 to 5.476	0.38 ratio Interval 0.204 to 0.691	0.91 ratio Interval 0.452 to 1.827	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.351; Day 57	0.78 ratio Interval 0.227 to 2.712	16.96 ratio Interval 1.632 to 176.241	0.71 ratio Interval 0.325 to 1.545	—	—	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.351; Day 91	—	—	—	0.41 ratio Interval 0.205 to 0.808	0.78 ratio Interval 0.365 to 1.684	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.351; Day 181	—	—	—	0.33 ratio Interval 0.099 to 1.117	0.59 ratio Interval 0.155 to 2.238	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.351; Day 209	6.77 ratio Interval 0.21 to 218.085	—	0.95 ratio Interval 0.242 to 3.759	—	—	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.351; Day 271	—	—	—	0.16 ratio Interval 0.032 to 0.742	0.73 ratio Interval 0.192 to 2.813	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.351; Final Visit Cohorts A1 and A2 (approx. Day 394)	4.37 ratio Interval 0.102 to 187.648	—	1.77 ratio Interval 0.433 to 7.256	—	—	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.351; Final Visit Cohort B (approx. Day 366)	—	—	—	0.14 ratio Interval 0.034 to 0.54	0.97 ratio Interval 0.234 to 4.022	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.617.2; Day 15	—	—	—	0.43 ratio Interval 0.208 to 0.9	0.69 ratio Interval 0.293 to 1.611	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.617.2; Day 29	2.45 ratio Interval 0.183 to 32.786	0.77 ratio Interval 0.268 to 2.241	1.17 ratio Interval 0.386 to 3.544	0.47 ratio Interval 0.231 to 0.947	0.66 ratio Interval 0.305 to 1.447	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.617.2; Day 57	1.78 ratio Interval 0.293 to 10.846	1.42 ratio Interval 0.552 to 3.644	0.92 ratio Interval 0.345 to 2.469	—	—	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.617.2; Day 91	—	—	—	0.68 ratio Interval 0.266 to 1.74	0.61 ratio Interval 0.277 to 1.331	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.617.2; Day 181	—	—	—	0.46 ratio Interval 0.142 to 1.466	0.82 ratio Interval 0.274 to 2.465	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.617.2; Day 209	3.26 ratio Interval 0.388 to 27.333	—	0.59 ratio Interval 0.116 to 3.053	—	—	—	—	—
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154) Pseudoviral B.1.617.2; Day 271	—	—	—	0.41 ratio Interval 0.114 to 1.465	1.30 ratio Interval 0.482 to 3.497	—	—	—

PRIMARY outcome

Timeframe: Days 29, 57, 209, Final Visit (approx. Day 394) for Cohort A1, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B

Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G Variant, B.1.351 Variant, B.1.617.2 Variant, BA.1 Variant for the GMC ratio of ARCT-021 vs ARCT-165. Data are reported for the ARCT-021 arm (vs ARCT-165 values).

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral D614G; Day 209	NA ratio Data were non-estimable because values were below the limit of quantification for all participants in the arm.	—	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral D614G; Day 271	—	0.28 ratio Interval 0.117 to 0.684	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral D614G; Day 15	—	0.70 ratio Interval 0.368 to 1.335	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral D614G; Day 29	4.00 ratio Interval 0.063 to 252.69	0.79 ratio Interval 0.358 to 1.746	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral D614G; Day 57	0.48 ratio Interval 0.004 to 53.354	—	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral D614G; Day 91	—	1.06 ratio Interval 0.46 to 2.432	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral D614G; Day 181	—	0.70 ratio Interval 0.186 to 2.624	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394)	NA ratio Data were non-estimable because values were below the limit of quantification for all participants in the arm.	—	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral D614G; Final Visit Cohort B (approx. Day 366)	—	0.29 ratio Interval 0.062 to 1.377	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.351; Day 15	—	0.37 ratio Interval 0.192 to 0.731	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.351; Day 29	0.54 ratio Interval 0.061 to 4.779	0.41 ratio Interval 0.221 to 0.774	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.351; Day 57	0.05 ratio Interval 0.004 to 0.609	—	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.351; Day 91	—	0.52 ratio Interval 0.232 to 1.16	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.351; Day 181	—	0.56 ratio Interval 0.122 to 2.616	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.351; Day 209	NA ratio Data were non-estimable because values were below the limit of quantification for all participants in the arm.	—	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.351; Day 271	—	0.21 ratio Interval 0.037 to 1.223	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.351; Final Visit Cohorts A1 and A2 (approx. Day 394)	NA ratio Data were non-estimable because values were below the limit of quantification for all participants in the arm.	—	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.351; Final Visit Cohort B (approx. Day 366)	—	0.14 ratio Interval 0.028 to 0.688	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.617.2; Day 15	—	0.63 ratio Interval 0.328 to 1.21	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.617.2; Day 29	3.16 ratio Interval 0.028 to 357.696	0.70 ratio Interval 0.365 to 1.357	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.617.2; Day 57	1.26 ratio Interval 0.053 to 29.735	—	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.617.2; Day 91	—	0.68 ratio Interval 0.266 to 1.74	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.617.2; Day 181	—	0.56 ratio Interval 0.159 to 1.948	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.617.2; Day 209	NA ratio Data were non-estimable because values were below the limit of quantification for all participants in the arm.	—	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.617.2; Day 271	—	0.31 ratio Interval 0.109 to 0.904	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.617.2; Final Visit Cohorts A1 and A2 (approx. Day 394)	NA ratio Data were non-estimable because values were below the limit of quantification for all participants in the arm.	—	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral B.1.617.2; Final Visit Cohort B (approx. Day 366)	—	0.27 ratio Interval 0.065 to 1.097	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral BA.1 Variant; Day 15	—	0.29 ratio Interval 0.156 to 0.537	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral BA.1 Variant; Day 29	1.45 ratio Interval 0.304 to 6.868	0.34 ratio Interval 0.174 to 0.654	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral BA.1 Variant; Day 57	0.12 ratio Interval 0.003 to 4.66	—	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral BA.1 Variant; Day 91	—	0.43 ratio Interval 0.182 to 0.996	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral BA.1 Variant; Day 181	—	0.27 ratio Interval 0.059 to 1.217	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral BA.1 Variant; Day 209	NA ratio Data were non-estimable because values were below the limit of quantification for all participants in the arm.	—	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral BA.1 Variant; Day 271	—	0.15 ratio Interval 0.042 to 0.57	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral BA.1 Variant; Final Visit Cohorts A1 and A2 (approx. Day 394)	NA ratio Data were non-estimable because values were below the limit of quantification for all participants in the arm.	—	—	—	—	—	—	—
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B) Pseudoviral BA.1 Variant; Final Visit Cohort B (approx. Day 366)	—	0.12 ratio Interval 0.024 to 0.622	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and Day 57 for Cohorts A1 and A2, Baseline and Day 15 for Cohort B

Spike binding antibody levels expressed as GMCs are reported for ancestral, D614G, and B.1.351 variants and RBD binding antibodies for ancestral strain.

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=3 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=18 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs Baseline; RBD (Ancestral)	0.0 AU/mL Interval 0.0 to 0.0	0.1 AU/mL Interval 0.0 to 1.2	0.1 AU/mL Interval 0.0 to 0.7	34 AU/mL Interval 9.0 to 124.0	29 AU/mL Interval 14.0 to 60.0	9 AU/mL Interval 6.0 to 14.0	9 AU/mL Interval 4.0 to 21.0	10 AU/mL Interval 6.0 to 16.0
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs Baseline; Spike (Ancestral)	0.0 AU/mL Interval 0.0 to 0.2	0.0 AU/mL Interval 0.0 to 0.4	0.3 AU/mL Interval 0.0 to 1.7	44 AU/mL Interval 13.0 to 156.0	49 AU/mL Interval 27.0 to 90.0	18 AU/mL Interval 12.0 to 27.0	17 AU/mL Interval 8.0 to 39.0	19 AU/mL Interval 11.0 to 33.0
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs Baseline; Spike (D614G)	0.0 AU/mL Interval 0.0 to 0.2	0.1 AU/mL Interval 0.0 to 0.9	0.2 AU/mL Interval 0.0 to 1.7	47 AU/mL Interval 14.0 to 161.0	52 AU/mL Interval 29.0 to 95.0	19 AU/mL Interval 13.0 to 27.0	18 AU/mL Interval 8.0 to 40.0	20 AU/mL Interval 11.0 to 35.0
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs Baseline; Spike (B.1.351)	0.0 AU/mL Interval 0.0 to 0.2	0.0 AU/mL Interval 0.0 to 0.5	0.2 AU/mL Interval 0.0 to 1.6	30 AU/mL Interval 11.0 to 77.0	32 AU/mL Interval 19.0 to 56.0	8 AU/mL Interval 6.0 to 12.0	8 AU/mL Interval 4.0 to 17.0	9 AU/mL Interval 5.0 to 16.0
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs Day 57; RBD (Ancestral)	3.4 AU/mL Interval 0.1 to 133.7	34.5 AU/mL Interval 0.0 to 13491400.0	8.2 AU/mL Interval 1.2 to 54.5	138 AU/mL Interval 49.0 to 386.0	186 AU/mL Interval 128.0 to 270.0	—	—	—
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs Day 57; Spike (Ancestral)	10.6 AU/mL Interval 0.4 to 285.1	52.4 AU/mL Interval 0.0 to 3217076.2	19.1 AU/mL Interval 3.3 to 108.8	181 AU/mL Interval 65.0 to 504.0	265 AU/mL Interval 196.0 to 358.0	—	—	—
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs Day 57; Spike (D614G)	10.7 AU/mL Interval 0.4 to 276.8	55.8 AU/mL Interval 0.0 to 1948962.5	19.8 AU/mL Interval 3.6 to 110.4	187 AU/mL Interval 69.0 to 511.0	277 AU/mL Interval 205.0 to 375.0	—	—	—
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs Day 57; Spike (B.1.351)	5.0 AU/mL Interval 0.2 to 147.4	61.1 AU/mL Interval 0.0 to 7370140.4	5.8 AU/mL Interval 0.6 to 58.4	119 AU/mL Interval 51.0 to 278.0	147 AU/mL Interval 112.0 to 193.0	—	—	—
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs Day 15; RBD (Ancestral)	—	—	—	—	—	91 AU/mL Interval 57.0 to 146.0	171 AU/mL Interval 115.0 to 254.0	221 AU/mL Interval 118.0 to 415.0
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs Day 15; Spike (Ancestral)	—	—	—	—	—	138 AU/mL Interval 89.0 to 215.0	231 AU/mL Interval 150.0 to 355.0	290 AU/mL Interval 164.0 to 514.0
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs Day 15; Spike (D614G)	—	—	—	—	—	142 AU/mL Interval 92.0 to 217.0	235 AU/mL Interval 154.0 to 359.0	296 AU/mL Interval 166.0 to 529.0
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs Day 15; Spike (B.1.351)	—	—	—	—	—	57 AU/mL Interval 40.0 to 82.0	117 AU/mL Interval 79.0 to 172.0	123 AU/mL Interval 71.0 to 212.0

PRIMARY outcome

Timeframe: Day 57 for Cohorts A1 and A2, Day 15 for Cohort B

Spike binding antibody levels expressed as GMFRs are reported for ancestral, D614G, and B.1.351 variants and RBD binding antibody levels expressed as GMFR for ancestral strain.

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=2 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=15 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=11 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs Day 57; RBD (Ancestral)	129 ratio Interval 6.0 to 2894.0	286 ratio Interval 0.0 to 46860600000.0	110 ratio Interval 8.0 to 1560.0	4.1 ratio Interval 1.4 to 12.3	4.9 ratio Interval 3.0 to 8.0	—	—	—
Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs Day 57; Spike (Ancestral)	231 ratio Interval 10.0 to 5236.0	807 ratio Interval 0.0 to 184116000000.0	76 ratio Interval 5.0 to 1279.0	4.1 ratio Interval 1.6 to 10.8	4.2 ratio Interval 2.8 to 6.3	—	—	—
Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs Day 57; Spike (D614G)	237 ratio Interval 10.0 to 5730.0	667 ratio Interval 0.0 to 2176320000000.0	84 ratio Interval 5.0 to 1404.0	4.0 ratio Interval 1.5 to 10.4	4.1 ratio Interval 2.8 to 6.1	—	—	—
Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs Day 57; Spike (B.1.351)	136 ratio Interval 5.0 to 4083.0	1076 ratio Interval 0.0 to 12500400000000.0	32 ratio Interval 3.0 to 361.0	4.0 ratio Interval 1.6 to 10.2	3.6 ratio Interval 2.4 to 5.4	—	—	—
Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs Day 15; RBD (Ancestral)	—	—	—	—	—	10 ratio Interval 6.0 to 16.0	19 ratio Interval 10.0 to 38.0	21 ratio Interval 11.0 to 40.0
Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs Day 15; Spike (Ancestral)	—	—	—	—	—	8 ratio Interval 5.0 to 13.0	13 ratio Interval 7.0 to 25.0	14 ratio Interval 8.0 to 26.0
Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs Day 15; Spike (D614G)	—	—	—	—	—	8 ratio Interval 5.0 to 13.0	13 ratio Interval 7.0 to 25.0	14 ratio Interval 7.0 to 26.0
Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs Day 15; Spike (B.1.351)	—	—	—	—	—	7 ratio Interval 4.0 to 11.0	15 ratio Interval 8.0 to 27.0	13 ratio Interval 7.0 to 22.0

PRIMARY outcome

Timeframe: Day 57 for Cohorts A1 and A2, Day 15 for Cohort B

Population: Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed =participants evaluable for endpoint. Number analyzed =participants evaluable at specified timepoint.

Data are reported for ancestral, D614G, and B.1.351 variants for Spike binding antibodies and ancestral for RBD binding antibodies.

Outcome measures

Outcome measures
Measure	Cohort A1: ARCT-021 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=2 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=15 Participants Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=11 Participants Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels Day 57; RBD (Ancestral)	4 Participants	2 Participants	4 Participants	3 Participants	9 Participants	—	—	—
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels Day 57; Spike (Ancestral)	4 Participants	2 Participants	4 Participants	3 Participants	8 Participants	—	—	—
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels Day 57; Spike (D614G)	4 Participants	2 Participants	4 Participants	3 Participants	8 Participants	—	—	—
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels Day 57; Spike (B.1.351)	4 Participants	2 Participants	4 Participants	3 Participants	6 Participants	—	—	—
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels Day 15; RBD (Ancestral)	—	—	—	—	—	11 Participants	11 Participants	10 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels Day 15; Spike (Ancestral)	—	—	—	—	—	9 Participants	10 Participants	10 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels Day 15; Spike (D614G)	—	—	—	—	—	9 Participants	11 Participants	10 Participants
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels Day 15; Spike (B.1.351)	—	—	—	—	—	9 Participants	11 Participants	10 Participants

Adverse Events

Cohort A1: ARCT-021

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort A1: ARCT-165

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort A1: ARCT-154

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort A2: ARCT-021

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort A2: ARCT-154

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Cohort B: ARCT-021

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Cohort B: ARCT-165

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Cohort B: ARCT-154

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A1: ARCT-021 n=4 participants at risk Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=4 participants at risk Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 participants at risk Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 participants at risk Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=18 participants at risk Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 participants at risk Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 participants at risk Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 participants at risk Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Pregnancy, puerperium and perinatal conditions Spontaneous abortion	0.00% 0/3 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/1 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/2 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/10 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/9 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/7 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Psychiatric disorders Depression	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.

Other adverse events

Other adverse events
Measure	Cohort A1: ARCT-021 n=4 participants at risk Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A1: ARCT-165 n=4 participants at risk Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort A1: ARCT-154 n=4 participants at risk Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort A2: ARCT-021 n=6 participants at risk Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort A2: ARCT-154 n=18 participants at risk Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.	Cohort B: ARCT-021 n=12 participants at risk Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.	Cohort B: ARCT-165 n=12 participants at risk Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.	Cohort B: ARCT-154 n=12 participants at risk Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	66.7% 4/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	83.3% 15/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 2/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Infections and infestations COVID-19	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	33.3% 2/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	33.3% 6/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	33.3% 4/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	50.0% 6/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	50.0% 6/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Infections and infestations Conjunctivitis	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Infections and infestations Fungal infection	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Infections and infestations Gastroenteritis	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 1/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Infections and infestations Pericoronitis	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Infections and infestations Rhinitis	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Infections and infestations Tinea cruris	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Infections and infestations Tonsillitis	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 2/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 1/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 2/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 2/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Respiratory, thoracic and mediastinal disorders Nasal congestion	50.0% 2/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 1/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 2/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 2/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	50.0% 2/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	11.1% 2/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 2/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	11.1% 2/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Nervous system disorders Headache	50.0% 2/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 1/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	27.8% 5/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Nervous system disorders Tension headache	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 1/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
General disorders Fatigue	50.0% 2/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
General disorders Pyrexia	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
General disorders Injection site pain	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
General disorders Injection site pruritus	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
General disorders Swelling face	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	50.0% 2/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	11.1% 2/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 2/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 2/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	16.7% 1/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Gastrointestinal disorders Gingival hypertrophy	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Gastrointestinal disorders Nausea	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Gastrointestinal disorders Vomiting	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Investigations Blood creatine phosphokinase increased	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	5.6% 1/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	25.0% 1/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Nervous system disorders Anosmia	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
General disorders Influenza like illness	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
General disorders Pain	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Gastrointestinal disorders Oral lichen planus	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Ear and labyrinth disorders Ear pain	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Psychiatric disorders Attention deficit hyperactivity disorder	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/4 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/6 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/18 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	8.3% 1/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.	0.00% 0/12 • Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.

Additional Information

Arcturus Therapeutics, Inc.

Phone: 858-900-2660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place