Trial Outcomes & Findings for Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults (NCT NCT06279871)
NCT ID: NCT06279871
Last Updated: 2025-12-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1514 participants
Primary outcome timeframe
Day 29
Results posted on
2025-12-12
Participant Flow
This study utilized the study group (ARCT-154 vaccine) from study ARCT-154-J01 as a historical control. The participants in the historical control arm were not considered enrolled in this study.
Participant milestones
| Measure |
Cohort A Group 1a: ARCT-2303+ Quadrivalent Influenza Vaccine (QIV) + Placebo
Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29.
|
Cohort A Group 2a: ARCT-2303 + Placebo + QIV
Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
ARCT-154-J01 (Historical Control)
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
408
|
406
|
405
|
99
|
98
|
98
|
385
|
|
Overall Study
Received Dose 1
|
403
|
403
|
398
|
99
|
98
|
98
|
385
|
|
Overall Study
Received Dose 2
|
393
|
394
|
390
|
95
|
97
|
96
|
0
|
|
Overall Study
COMPLETED
|
392
|
387
|
389
|
97
|
98
|
97
|
385
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
16
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort A Group 1a: ARCT-2303+ Quadrivalent Influenza Vaccine (QIV) + Placebo
Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29.
|
Cohort A Group 2a: ARCT-2303 + Placebo + QIV
Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
ARCT-154-J01 (Historical Control)
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other than Specified
|
1
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
4
|
2
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
11
|
10
|
8
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults
Baseline characteristics by cohort
| Measure |
Cohort A Group 1a: ARCT-2303+ QIV + Placebo
n=403 Participants
Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29.
|
Cohort A Group 2a: ARCT-2303 + Placebo + QIV
n=403 Participants
Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
n=398 Participants
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
n=99 Participants
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=98 Participants
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
n=98 Participants
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
ARCT-154-J01 (Historical Control)
n=385 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Total
n=1884 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 12.0 • n=26 Participants
|
36.8 years
STANDARD_DEVIATION 12.1 • n=24 Participants
|
39.2 years
STANDARD_DEVIATION 11.9 • n=50 Participants
|
69.6 years
STANDARD_DEVIATION 5.3 • n=391 Participants
|
70.4 years
STANDARD_DEVIATION 5.4 • n=1175 Participants
|
70.4 years
STANDARD_DEVIATION 4.9 • n=813 Participants
|
45.3 years
STANDARD_DEVIATION 11.9 • n=25 Participants
|
44.2 years
STANDARD_DEVIATION 16.9 • n=9 Participants
|
|
Sex: Female, Male
Female
|
259 Participants
n=26 Participants
|
255 Participants
n=24 Participants
|
243 Participants
n=50 Participants
|
64 Participants
n=391 Participants
|
68 Participants
n=1175 Participants
|
63 Participants
n=813 Participants
|
228 Participants
n=25 Participants
|
1180 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=26 Participants
|
148 Participants
n=24 Participants
|
155 Participants
n=50 Participants
|
35 Participants
n=391 Participants
|
30 Participants
n=1175 Participants
|
35 Participants
n=813 Participants
|
157 Participants
n=25 Participants
|
704 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
65 Participants
n=26 Participants
|
67 Participants
n=24 Participants
|
64 Participants
n=50 Participants
|
23 Participants
n=391 Participants
|
15 Participants
n=1175 Participants
|
21 Participants
n=813 Participants
|
0 Participants
n=25 Participants
|
255 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
333 Participants
n=26 Participants
|
333 Participants
n=24 Participants
|
332 Participants
n=50 Participants
|
76 Participants
n=391 Participants
|
83 Participants
n=1175 Participants
|
77 Participants
n=813 Participants
|
385 Participants
n=25 Participants
|
1619 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=26 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=50 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=1175 Participants
|
0 Participants
n=813 Participants
|
0 Participants
n=25 Participants
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
18 Participants
n=26 Participants
|
11 Participants
n=24 Participants
|
16 Participants
n=50 Participants
|
4 Participants
n=391 Participants
|
6 Participants
n=1175 Participants
|
5 Participants
n=813 Participants
|
0 Participants
n=25 Participants
|
60 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
150 Participants
n=26 Participants
|
159 Participants
n=24 Participants
|
177 Participants
n=50 Participants
|
69 Participants
n=391 Participants
|
77 Participants
n=1175 Participants
|
68 Participants
n=813 Participants
|
385 Participants
n=25 Participants
|
1085 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
7 Participants
n=26 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=50 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=1175 Participants
|
0 Participants
n=813 Participants
|
0 Participants
n=25 Participants
|
12 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=50 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=1175 Participants
|
0 Participants
n=813 Participants
|
0 Participants
n=25 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
179 Participants
n=26 Participants
|
173 Participants
n=24 Participants
|
158 Participants
n=50 Participants
|
9 Participants
n=391 Participants
|
8 Participants
n=1175 Participants
|
10 Participants
n=813 Participants
|
0 Participants
n=25 Participants
|
537 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=26 Participants
|
15 Participants
n=24 Participants
|
13 Participants
n=50 Participants
|
7 Participants
n=391 Participants
|
2 Participants
n=1175 Participants
|
3 Participants
n=813 Participants
|
0 Participants
n=25 Participants
|
54 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=26 Participants
|
42 Participants
n=24 Participants
|
30 Participants
n=50 Participants
|
10 Participants
n=391 Participants
|
5 Participants
n=1175 Participants
|
12 Participants
n=813 Participants
|
0 Participants
n=25 Participants
|
133 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Study treatment arm: per protocol (PP) set for immunogenicity, participants in the Modified Intent-To-Treat Analysis Set (mITT) who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29 or Day 181) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. As pre-specified, data for groups 2a \& 2b were collected and are reported pooled as a combined group.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=473 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=385 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 2a and 2b and ARCT-154-J01 Historical Control: Geometric Mean Titers (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody Titers Against Omicron XBB.1.5 Subvariant at Day 29
|
718 Titer
Interval 652.0 to 791.0
|
263 Titer
Interval 236.0 to 293.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: Study treatment arm: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. As pre-specified, data for groups 2a \&2b were collected and are reported pooled as a combined group.
Seroconversion was defined as either a pre-vaccination titer below the lower limit of quantitation (LLOQ) and a postvaccination titer ≥4xLLOQ; or a pre-vaccination titer ≥LLOQ and a ≥4-fold increase in post-vaccination titer.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=473 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=385 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 2a and 2b and ARCT-154-J01 Historical Control: Number of Participants With Seroconversion to SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant at Day 29
|
349 Participants
|
175 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Influenza vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=375 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=376 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1a and 3a: Adjusted Hemagglutination Inhibition (HI) GMTs Against Influenza Vaccine Strains at Day 29
A/H1N1
|
338 titers
Interval 289.0 to 395.0
|
354 titers
Interval 304.0 to 413.0
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Adjusted Hemagglutination Inhibition (HI) GMTs Against Influenza Vaccine Strains at Day 29
A/H3N2
|
280 titers
Interval 242.0 to 325.0
|
269 titers
Interval 232.0 to 311.0
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Adjusted Hemagglutination Inhibition (HI) GMTs Against Influenza Vaccine Strains at Day 29
B/Victoria
|
109 titers
Interval 92.0 to 129.0
|
99 titers
Interval 84.0 to 117.0
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Adjusted Hemagglutination Inhibition (HI) GMTs Against Influenza Vaccine Strains at Day 29
B/Yamagata
|
123 titers
Interval 111.0 to 137.0
|
112 titers
Interval 101.0 to 125.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=375 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=378 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1a and 2a: Adjusted GMTs of SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant at Day 29
|
768 titers
Interval 680.0 to 867.0
|
954 titers
Interval 844.0 to 1077.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1a: Days 1 and 29; Group 2a: Days 1, 29, and 181Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29 or Day 181) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable at the specified timepoint.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=375 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=378 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1a and 2a: GMT of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 1, 29 and 181
Day 181
|
—
|
794 titers
Interval 653.0 to 967.0
|
—
|
—
|
—
|
—
|
|
Groups 1a and 2a: GMT of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 1, 29 and 181
Day 29
|
789 titers
Interval 708.0 to 880.0
|
1072 titers
Interval 957.0 to 1199.0
|
—
|
—
|
—
|
—
|
|
Groups 1a and 2a: GMT of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 1, 29 and 181
Day 1
|
118 titers
Interval 103.0 to 135.0
|
140 titers
Interval 123.0 to 169.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1a: Day 29; Group 2a: Days 29 and 181Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29 or Day 181) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable at the specified timepoint.
GMFR is reported as a ratio to Day 1.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=375 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=378 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1a and 2a: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 29 and 181
Day 29
|
6.7 ratio
Interval 6.0 to 7.5
|
7.7 ratio
Interval 6.8 to 8.6
|
—
|
—
|
—
|
—
|
|
Groups 1a and 2a: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 29 and 181
Day 181
|
—
|
5.3 ratio
Interval 4.2 to 6.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Seroconversion was defined as either a pre-vaccination titer below the LLOQ and a postvaccination titer ≥4xLLOQ; or a pre-vaccination titer ≥LLOQ and a ≥4-fold increase in post-vaccination titer.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=375 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=378 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1a and 2a: Number of Participants With Seroconversion of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Day 29
|
242 Participants
|
279 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=375 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=378 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1a and 2a: Number of Participants With SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant Titer ≥ LLOQ at Days 1 and 29
Day 1
|
331 Participants
|
344 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1a and 2a: Number of Participants With SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant Titer ≥ LLOQ at Days 1 and 29
Day 29
|
375 Participants
|
378 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=375 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=376 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1a and 3a: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
B/Victoria Day 1
|
13 titer
Interval 12.0 to 15.0
|
15 titer
Interval 13.0 to 17.0
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
B/Victoria Day 29
|
109 titer
Interval 95.0 to 125.0
|
102 titer
Interval 90.0 to 117.0
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
B/Yamagata Day 1
|
29 titer
Interval 26.0 to 32.0
|
34 titer
Interval 30.0 to 37.0
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
B/Yamagata Day 29
|
132 titer
Interval 119.0 to 145.0
|
126 titer
Interval 115.0 to 138.0
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
A/H1N1 Day 1
|
38 titer
Interval 33.0 to 44.0
|
37 titer
Interval 32.0 to 43.0
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
A/H1N1 Day 29
|
429 titer
Interval 374.0 to 493.0
|
433 titer
Interval 381.0 to 491.0
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
A/H3N2 Day 1
|
32 titer
Interval 28.0 to 37.0
|
36 titer
Interval 31.0 to 42.0
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
A/H3N2 Day 29
|
331 titer
Interval 291.0 to 378.0
|
334 titer
Interval 295.0 to 377.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMFR is reported as a ratio to Day 1.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=375 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=376 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1a and 3a: GMFR of HI Assay Titers Against Influenza Vaccine Strains at Day 29
A/H1N1
|
11.2 ratio
Interval 9.6 to 13.2
|
11.6 ratio
Interval 9.8 to 13.6
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: GMFR of HI Assay Titers Against Influenza Vaccine Strains at Day 29
A/H3N2
|
10.3 ratio
Interval 8.9 to 11.9
|
9.2 ratio
Interval 8.0 to 10.6
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: GMFR of HI Assay Titers Against Influenza Vaccine Strains at Day 29
B/Victoria
|
8.1 ratio
Interval 7.0 to 9.4
|
6.9 ratio
Interval 6.0 to 7.9
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: GMFR of HI Assay Titers Against Influenza Vaccine Strains at Day 29
B/Yamagata
|
4.6 ratio
Interval 4.1 to 5.1
|
3.7 ratio
Interval 3.4 to 4.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Seroconversion was defined as either a pre-vaccination titer below the LLOQ and a postvaccination titer ≥4xLLOQ; or a pre-vaccination titer ≥LLOQ and a ≥4-fold increase in post-vaccination titer. Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=375 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=376 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1a and 3a: Number of Participants With Seroconversion of HI Assay Titers Against Influenza Vaccine Strains at Day 29
A/H1N1
|
267 Participants
|
259 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Number of Participants With Seroconversion of HI Assay Titers Against Influenza Vaccine Strains at Day 29
A/H3N2
|
266 Participants
|
266 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Number of Participants With Seroconversion of HI Assay Titers Against Influenza Vaccine Strains at Day 29
B/Victoria
|
233 Participants
|
215 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Number of Participants With Seroconversion of HI Assay Titers Against Influenza Vaccine Strains at Day 29
B/Yamagata
|
197 Participants
|
167 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=375 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=376 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1a and 3a: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
A/H1N1 Day 1
|
197 Participants
|
195 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
A/H1N1 Day 29
|
354 Participants
|
367 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
A/H3N2 Day 1
|
178 Participants
|
200 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
A/H3N2 Day 29
|
361 Participants
|
364 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
B/Victoria Day 1
|
73 Participants
|
83 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
B/Victoria Day 29
|
299 Participants
|
294 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
B/Yamagata Day 1
|
165 Participants
|
201 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1a and 3a: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
B/Yamagata Day 29
|
345 Participants
|
347 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1b: Days 1 and 29, Group 2b: Days 1, 29 and 181Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29 or Day 181) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. Overall number of participants analyzed = number evaluable for the outcome measure. Number analyzed = participants evaluable at the specified timepoint.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=92 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=95 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1b and 2b: GMTs of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 1, 29 and 181
Day 1
|
138 titer
Interval 106.0 to 180.0
|
206 titer
Interval 158.0 to 269.0
|
—
|
—
|
—
|
—
|
|
Groups 1b and 2b: GMTs of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 1, 29 and 181
Day 29
|
932 titer
Interval 742.0 to 1170.0
|
1420 titer
Interval 1126.0 to 1791.0
|
—
|
—
|
—
|
—
|
|
Groups 1b and 2b: GMTs of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 1, 29 and 181
Day 181
|
—
|
878 titer
Interval 738.0 to 1045.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Group 1b: Day 29 and Group 2b: Days 29 and 181Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29 or Day 181) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. Overall number of participants analyzed = number evaluable for the outcome measure. Number analyzed = participants evaluable at the specified timepoint.
GMFR is reported as a ratio to Day 1.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=92 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=95 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1b and 2b: GMFRs of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 29 and 181
Day 29
|
6.8 ratio
Interval 5.3 to 8.6
|
6.9 ratio
Interval 5.4 to 8.8
|
—
|
—
|
—
|
—
|
|
Groups 1b and 2b: GMFRs of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 29 and 181
Day 181
|
—
|
4.3 ratio
Interval 3.2 to 5.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Seroconversion was defined as either a pre-vaccination titer below the LLOQ and a postvaccination titer ≥4xLLOQ; or a pre-vaccination titer ≥LLOQ and a ≥4-fold increase in post-vaccination titer.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=92 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=95 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1b and 2b: Number of Participants With Seroconversion of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Day 29
|
66 Participants
|
70 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=92 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=95 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1b and 2b: Number of Participants With SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant Titer ≥ LLOQ at Days 1 and 29
Day 1
|
84 Participants
|
90 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1b and 2b: Number of Participants With SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant Titer ≥ LLOQ at Days 1 and 29
Day 29
|
92 Participants
|
95 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=92 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=93 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1b and 3b: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
A/H1N1 Day 1
|
115 titers
Interval 83.0 to 160.0
|
109 titers
Interval 78.0 to 153.0
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
A/H1N1 Day 29
|
1064 titers
Interval 827.0 to 1369.0
|
961 titers
Interval 773.0 to 1194.0
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
A/H3N2 Day 1
|
78 titers
Interval 56.0 to 110.0
|
92 titers
Interval 68.0 to 127.0
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
A/H3N2 Day 29
|
475 titers
Interval 368.0 to 613.0
|
453 titers
Interval 342.0 to 600.0
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
B/Victoria Day 1
|
20 titers
Interval 15.0 to 26.0
|
29 titers
Interval 20.0 to 41.0
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
B/Victoria Day 29
|
121 titers
Interval 91.0 to 160.0
|
132 titers
Interval 98.0 to 178.0
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
B/Yamagata Day 1
|
25 titers
Interval 19.0 to 34.0
|
27 titers
Interval 20.0 to 35.0
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29
B/Yamagata Day 29
|
138 titers
Interval 108.0 to 176.0
|
132 titers
Interval 102.0 to 170.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMFR is reported as a ratio to Day 1.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=92 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=93 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1b and 3b: GMFRs of of HI Assay Titers Against Influenza Vaccine Strains at Day 29
A/H1N1
|
9.2 ratio
Interval 6.4 to 13.4
|
8.8 ratio
Interval 6.1 to 12.6
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: GMFRs of of HI Assay Titers Against Influenza Vaccine Strains at Day 29
A/H3N2
|
6.0 ratio
Interval 4.4 to 8.4
|
4.9 ratio
Interval 3.6 to 6.7
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: GMFRs of of HI Assay Titers Against Influenza Vaccine Strains at Day 29
B/Victoria
|
6.2 ratio
Interval 4.4 to 8.5
|
4.6 ratio
Interval 3.4 to 6.1
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: GMFRs of of HI Assay Titers Against Influenza Vaccine Strains at Day 29
B/Yamagata
|
5.5 ratio
Interval 4.0 to 7.6
|
5.0 ratio
Interval 3.8 to 6.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Seroconversion was defined as either a pre-vaccination titer below the LLOQ and a postvaccination titer ≥4xLLOQ; or a pre-vaccination titer ≥LLOQ and a ≥4-fold increase in post-vaccination titer. Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=92 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=93 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1b and 3b: Number of Participants With Seroconversion of HI Assay Titers Against Influenza Vaccine Strains at Day 29
A/H1N1
|
59 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: Number of Participants With Seroconversion of HI Assay Titers Against Influenza Vaccine Strains at Day 29
A/H3N2
|
50 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: Number of Participants With Seroconversion of HI Assay Titers Against Influenza Vaccine Strains at Day 29
B/Victoria
|
47 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: Number of Participants With Seroconversion of HI Assay Titers Against Influenza Vaccine Strains at Day 29
B/Yamagata
|
48 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data.
Vaccine strains analyzed for this outcome measure were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=92 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=93 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Groups 1b and 3b: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
A/H1N1 Day 1
|
75 Participants
|
71 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
A/H1N1 Day 29
|
92 Participants
|
93 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
A/H3N2 Day 1
|
62 Participants
|
70 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
A/H3N2 Day 29
|
90 Participants
|
91 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
B/Victoria Day 1
|
32 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
B/Victoria Day 29
|
76 Participants
|
80 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
B/Yamagata Day 1
|
37 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
|
Groups 1b and 3b: Number of Participants With HI Titer ≥1:40 at Days 1 and 29
B/Yamagata Day 29
|
84 Participants
|
81 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 and Day 36 (up to 7 days after each study vaccination)Population: Safety Analysis Set (SAF), which included all participants in the Exposed Set (participants who received at least one dose of a study vaccine) who provided any evaluable post-vaccination reactogenicity and/or safety data. Number analyzed = participants evaluable at the specified timepoint.
Systemic AEs: fatigue, headache, myalgia, arthralgia, nausea, dizziness, chills, and fever. Solicited local (injection site) AEs: injection site pain, erythema, and swelling. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=403 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=403 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
n=398 Participants
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
n=99 Participants
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=98 Participants
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
n=98 Participants
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Solicited Systemic AE after Second Vaccination (up to Day 36)
|
105 Participants
|
118 Participants
|
217 Participants
|
14 Participants
|
15 Participants
|
17 Participants
|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Solicited Local AE after First Vaccination (up to Day 8)
|
283 Participants
|
296 Participants
|
167 Participants
|
41 Participants
|
30 Participants
|
20 Participants
|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Solicited Systemic AE after First Vaccination (up to Day 8)
|
255 Participants
|
258 Participants
|
162 Participants
|
36 Participants
|
23 Participants
|
25 Participants
|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Solicited Local AE after Second Vaccination (up to Day 36)
|
38 Participants
|
146 Participants
|
263 Participants
|
5 Participants
|
15 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Up to Day 29 (Up to 28 days after first study vaccination) and up to Day 57 (28 days after second study vaccination)Population: Safety Analysis Set, which included all participants in the Exposed Set (participants who received at least one dose of a study vaccine) who provided any evaluable post-vaccination reactogenicity and/or safety data. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at the specified timepoint.
An unsolicited AE was an AE that was not listed as 'solicited' and was defined as any spontaneously occurring AE (serious and non-serious). Potential unsolicited AEs may have been medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a healthcare provider) or were of concern to the participants. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=403 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=403 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
n=398 Participants
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
n=99 Participants
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=98 Participants
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
n=98 Participants
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs
Day 29
|
79 Participants
|
81 Participants
|
68 Participants
|
13 Participants
|
8 Participants
|
16 Participants
|
|
Number of Participants With Unsolicited AEs
Day 57
|
71 Participants
|
62 Participants
|
75 Participants
|
9 Participants
|
6 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 181Population: Safety Analysis Set, which included all participants in the Exposed Set (participants who received at least one dose of a study vaccine) who provided any evaluable post-vaccination reactogenicity and/or safety data.
SAEs were defined as any event that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was an important medical event. A MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. AESIs were defined as AEs potentially associated with Coronavirus Disease 2019 (COVID-19) and COVID-19 vaccines. Number of participants with AEs leading to early termination included AEs leading to death. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=403 Participants
Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
ARCT-154-J01 (Historical Control)
n=403 Participants
Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
n=398 Participants
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
n=99 Participants
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=98 Participants
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
n=98 Participants
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), AEs Leading to Early Termination From Study, Medically Attended Adverse Event (MAAEs), and Adverse Event of Special Interest (AESIs)
SAEs
|
7 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), AEs Leading to Early Termination From Study, Medically Attended Adverse Event (MAAEs), and Adverse Event of Special Interest (AESIs)
AEs Leading to Early Termination from Study
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), AEs Leading to Early Termination From Study, Medically Attended Adverse Event (MAAEs), and Adverse Event of Special Interest (AESIs)
MAAEs
|
103 Participants
|
95 Participants
|
100 Participants
|
19 Participants
|
13 Participants
|
19 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), AEs Leading to Early Termination From Study, Medically Attended Adverse Event (MAAEs), and Adverse Event of Special Interest (AESIs)
AESIs
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Cohort A Group 1a: ARCT-2303+ QIV + Placebo
Serious events: 7 serious events
Other events: 65 other events
Deaths: 0 deaths
Cohort A Group 2a: ARCT-2303 + Placebo + QIV
Serious events: 5 serious events
Other events: 59 other events
Deaths: 0 deaths
Cohort A Group 3a: QIV + Placebo + ARCT-2303
Serious events: 6 serious events
Other events: 49 other events
Deaths: 0 deaths
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
Serious events: 5 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort A Group 1a: ARCT-2303+ QIV + Placebo
n=403 participants at risk
Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29.
|
Cohort A Group 2a: ARCT-2303 + Placebo + QIV
n=403 participants at risk
Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
n=398 participants at risk
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
n=99 participants at risk
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=98 participants at risk
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
n=98 participants at risk
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.25%
1/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.25%
1/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Eye disorders
Malignant glaucoma
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
General disorders
Impaired healing
|
0.25%
1/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.74%
3/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.25%
1/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.25%
1/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.25%
1/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Infections and infestations
Sepsis
|
0.25%
1/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Injury, poisoning and procedural complications
Cataract traumatic
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.25%
1/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.25%
1/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.25%
1/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.25%
1/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.25%
1/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.25%
1/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.25%
1/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/259 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.39%
1/255 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/243 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/64 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/68 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/63 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
1.0%
1/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.25%
1/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.25%
1/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.25%
1/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
Other adverse events
| Measure |
Cohort A Group 1a: ARCT-2303+ QIV + Placebo
n=403 participants at risk
Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29.
|
Cohort A Group 2a: ARCT-2303 + Placebo + QIV
n=403 participants at risk
Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29.
|
Cohort A Group 3a: QIV + Placebo + ARCT-2303
n=398 participants at risk
Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo
n=99 participants at risk
Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29.
|
Cohort B Group 2b: ARCT-2303 + Placebo + aQIV
n=98 participants at risk
Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29.
|
Cohort B Group 3b: aQIV + Placebo + ARCT-2303
n=98 participants at risk
Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
3.1%
3/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Infections and infestations
COVID-19
|
5.5%
22/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
5.2%
21/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
4.5%
18/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
3.0%
3/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
43/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
9.4%
38/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
7.8%
31/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
3.0%
3/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
3.1%
3/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
5.1%
5/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/403 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/398 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/99 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
0.00%
0/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
3.1%
3/98 • Day 1 up to Day 181
Safety analysis set, which included all participants in the Exposed Set (all participants who received at least one dose of a study vaccine in this study) who provided any evaluable post-vaccination reactogenicity and/or safety data. As pre-specified, mortality and adverse event data were collected and reported for participants enrolled in this study. The historical control group were not considered enrolled and were not assessed for deaths/adverse events in this study.
|
Additional Information
Arcturus Therapeutics, Inc.
Arcturus Therapeutics, Inc.
Phone: 858-900-2660
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place