Trial Outcomes & Findings for A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults (NCT NCT04668339)
NCT ID: NCT04668339
Last Updated: 2025-05-15
Results Overview
Per prespecified analysis, solicited local adverse events were defined as pain, erythema, swelling, or injection site tenderness. Solicited adverse reactions were recorded by the participant in an eDiary. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
581 participants
Primary outcome timeframe
For 7 days following each dose administration (Day 0 up to Day 7 for Vaccination 1 and Day 29 up to Day 35 for Vaccination 2)
Results posted on
2025-05-15
Participant Flow
Participant milestones
| Measure |
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
146
|
145
|
145
|
145
|
|
Overall Study
Received Vaccination 1
|
146
|
145
|
144
|
145
|
|
Overall Study
Received Vaccination 2
|
132
|
135
|
139
|
139
|
|
Overall Study
Received Booster Vaccination
|
51
|
60
|
58
|
1
|
|
Overall Study
Booster - ARCT-021 5 mcg
|
13
|
16
|
15
|
0
|
|
Overall Study
Booster - ARCT-154 5 mcg
|
12
|
15
|
14
|
0
|
|
Overall Study
Booster - ARCT-165 5 mcg
|
14
|
14
|
14
|
0
|
|
Overall Study
Booster - Placebo
|
12
|
14
|
15
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
146
|
145
|
145
|
145
|
Reasons for withdrawal
| Measure |
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
14
|
12
|
8
|
5
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Other than specified
|
3
|
0
|
1
|
0
|
|
Overall Study
Participant unblinded between Day 98 and 198
|
6
|
5
|
4
|
91
|
|
Overall Study
Vaccine not Administered
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
18
|
23
|
12
|
20
|
|
Overall Study
Withdrawal by Subject
|
45
|
46
|
46
|
27
|
|
Overall Study
Study Terminated by Sponsor
|
59
|
59
|
71
|
1
|
Baseline Characteristics
A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Treatment A
n=145 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=144 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=145 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=146 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Total
n=580 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 16.15 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 15.16 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 17.08 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 15.59 • n=4 Participants
|
48.8 years
STANDARD_DEVIATION 15.99 • n=21 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
266 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
314 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
131 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
509 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
108 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
429 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: For 7 days following each dose administration (Day 0 up to Day 7 for Vaccination 1 and Day 29 up to Day 35 for Vaccination 2)Population: The Reactogenicity analysis set included all participants who received any dose of priming study vaccine (ARCT-021 or placebo) and provided at least 1 reactogenicity diary report for the time period evaluated. Here, number analyzed signifies those participants who were evaluable in specified categories only.
Per prespecified analysis, solicited local adverse events were defined as pain, erythema, swelling, or injection site tenderness. Solicited adverse reactions were recorded by the participant in an eDiary. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Treatment A
n=142 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=142 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=144 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=146 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Pain
|
52.8 percentage of participants
|
48.6 percentage of participants
|
57.6 percentage of participants
|
8.2 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Erythema (Redness)
|
14.8 percentage of participants
|
19.7 percentage of participants
|
11.1 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Swelling (Hardness)
|
11.3 percentage of participants
|
15.5 percentage of participants
|
9.0 percentage of participants
|
5.5 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Injection Site Tenderness
|
79.6 percentage of participants
|
75.4 percentage of participants
|
83.3 percentage of participants
|
19.9 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Pain
|
7.9 percentage of participants
|
33.1 percentage of participants
|
44.5 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Erythema (Redness)
|
7.1 percentage of participants
|
14.6 percentage of participants
|
8.0 percentage of participants
|
8.9 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Swelling (Hardness)
|
4.7 percentage of participants
|
11.5 percentage of participants
|
4.4 percentage of participants
|
3.0 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Injection Site Tenderness
|
15.0 percentage of participants
|
67.7 percentage of participants
|
75.2 percentage of participants
|
15.6 percentage of participants
|
PRIMARY outcome
Timeframe: For 7 days following each dose administration (Day 208 up to Day 215)Population: The Booster Reactogenicity analysis set included all participants who received any dose of booster vaccination (ARCT-021, ARCT-145, ARCT-156 or placebo) and provided at least 1 diary entry for the time period evaluated. Participants were analyzed according to the vaccine actually received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable in specified categories only.
Per prespecified analysis, solicited local adverse events were defined as pain, erythema, swelling, or injection site tenderness. Solicited adverse reactions were recorded by the participant in an eDiary. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=36 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=38 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=39 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination
Pain
|
51.2 percentage of participants
|
36.8 percentage of participants
|
39.5 percentage of participants
|
5.1 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination
Erythema (Redness)
|
9.3 percentage of participants
|
7.9 percentage of participants
|
7.9 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination
Swelling (Hardness)
|
11.6 percentage of participants
|
5.3 percentage of participants
|
7.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination
Injection Site Tenderness
|
81.4 percentage of participants
|
65.8 percentage of participants
|
73.7 percentage of participants
|
12.8 percentage of participants
|
PRIMARY outcome
Timeframe: For 7 days following each dose administration (Day 0 up to Day 7 for Vaccination 1 and Day 29 up to Day 35 for Vaccination 2)Population: The Reactogenicity analysis set included all participants who received any dose of priming study vaccine (ARCT-021 or placebo) and provided at least 1 reactogenicity diary report for the time period evaluated. Here, number analyzed signifies those participants who were evaluable in specified categories only.
Per prespecified analysis, solicited systemic adverse events were defined as fever, headache, fatigue, myalgia, arthralgia, nausea, chills, diarrhea, dizziness, and vomiting. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Treatment A
n=142 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=142 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=144 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=146 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Dizziness
|
7.1 percentage of participants
|
4.6 percentage of participants
|
17.5 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Vomiting
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Fever
|
4.2 percentage of participants
|
2.1 percentage of participants
|
2.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Headache
|
43.0 percentage of participants
|
34.5 percentage of participants
|
39.6 percentage of participants
|
19.2 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Fatigue
|
47.2 percentage of participants
|
36.6 percentage of participants
|
40.3 percentage of participants
|
20.5 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Myalgia
|
44.4 percentage of participants
|
28.9 percentage of participants
|
39.6 percentage of participants
|
8.2 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Arthralgia
|
21.1 percentage of participants
|
15.5 percentage of participants
|
17.4 percentage of participants
|
8.2 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Nausea
|
10.6 percentage of participants
|
8.5 percentage of participants
|
6.3 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Chills
|
28.9 percentage of participants
|
16.9 percentage of participants
|
22.9 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Diarrhea
|
12.0 percentage of participants
|
12.7 percentage of participants
|
16.0 percentage of participants
|
9.6 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Dizziness
|
7.7 percentage of participants
|
9.9 percentage of participants
|
9.0 percentage of participants
|
8.9 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 1: Vomiting
|
1.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Fever
|
0.8 percentage of participants
|
3.1 percentage of participants
|
6.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Headache
|
12.6 percentage of participants
|
30.0 percentage of participants
|
40.9 percentage of participants
|
16.3 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Fatigue
|
14.2 percentage of participants
|
33.1 percentage of participants
|
44.5 percentage of participants
|
21.5 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Myalgia
|
6.3 percentage of participants
|
34.6 percentage of participants
|
32.8 percentage of participants
|
14.1 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Arthralgia
|
3.1 percentage of participants
|
16.9 percentage of participants
|
24.1 percentage of participants
|
9.6 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Nausea
|
5.5 percentage of participants
|
6.9 percentage of participants
|
8.8 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Chills
|
2.4 percentage of participants
|
13.1 percentage of participants
|
22.6 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Vaccination 2: Diarrhea
|
7.1 percentage of participants
|
10.0 percentage of participants
|
10.9 percentage of participants
|
12.6 percentage of participants
|
PRIMARY outcome
Timeframe: For 7 days post booster dose administration (Day 208 up to Day 215)Population: The Booster Reactogenicity analysis set included all participants who received any dose of booster vaccination (ARCT-021, ARCT-145, ARCT-156 or placebo) and provided at least 1 diary entry for the time period evaluated. Participants were analyzed according to the vaccine actually received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable in specified categories only.
Per prespecified analysis, solicited systemic adverse events were defined as fever, headache, fatigue, myalgia, arthralgia, nausea, chills, diarrhea, dizziness, and vomiting. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=35 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=38 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=38 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Fever
|
11.6 percentage of participants
|
0 percentage of participants
|
5.3 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Headache
|
60.5 percentage of participants
|
34.2 percentage of participants
|
31.6 percentage of participants
|
25.6 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Fatigue
|
69.8 percentage of participants
|
34.2 percentage of participants
|
50.0 percentage of participants
|
25.6 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Myalgia
|
62.8 percentage of participants
|
31.6 percentage of participants
|
42.1 percentage of participants
|
12.8 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Diarrhea
|
25.6 percentage of participants
|
18.4 percentage of participants
|
10.5 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Dizziness
|
32.6 percentage of participants
|
10.5 percentage of participants
|
10.5 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Arthralgia
|
48.8 percentage of participants
|
21.1 percentage of participants
|
31.6 percentage of participants
|
12.8 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Nausea
|
27.9 percentage of participants
|
7.9 percentage of participants
|
10.5 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Chills
|
44.2 percentage of participants
|
18.4 percentage of participants
|
21.1 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Vomiting
|
7.0 percentage of participants
|
2.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 28 days following each dose administration (Day 0 up to Day 28 for Vaccination 1 and Day 29 up to Day 56 for Vaccination 2)Population: Safety Set included all participants who received at least 1 dose of priming study vaccine (ARCT-021 or placebo). Participants were analyzed according to the vaccine received at the time of priming or booster vaccination. One participant who was randomized to group A received treatment dosing and schedule for group D due to a dosing error. This participant is included in group D for the safety set.
An unsolicited AE was defined as any AE (serious and nonserious) occurring after administration of first dose of study vaccine and before the end of study. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Treatment A
n=145 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=144 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=145 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=146 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination
Vaccination 1
|
20.7 percentage of participants
|
22.2 percentage of participants
|
17.9 percentage of participants
|
19.2 percentage of participants
|
|
Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination
Vaccination 2
|
19.1 percentage of participants
|
19.4 percentage of participants
|
8.6 percentage of participants
|
20.7 percentage of participants
|
PRIMARY outcome
Timeframe: 28 days following each dose administration (Day 208 up to 236 days)Population: Booster Safety Set included all participants who received at least 1 dose of booster study vaccine (ARCT-021, ARCT-154, ARCT-165, or placebo) or had safety data collected in the period following booster administration.
An unsolicited AE was defined as any AE (serious and nonserious) occurring after administration of first dose of study vaccine and before the end of study. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Treatment A
n=44 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=41 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=42 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=99 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Booster Vaccination
|
15.9 percentage of participants
|
14.6 percentage of participants
|
11.9 percentage of participants
|
9.1 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 207Population: Safety Set included all participants who received at least 1 dose of priming study vaccine (ARCT-021 or placebo). Participants were analyzed according to the vaccine received at the time of priming or booster vaccination. One participant who was randomized to group A received treatment dosing and schedule for group D due to a dosing error. This participant is included in group D for the safety set.
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, resulted in a congenital anomaly or birth defect, or was an important medical event. An NOCD was defined as any AE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Treatment A
n=145 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=144 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=145 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=146 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination
Any SAEs
|
0 percentage of participants
|
2.1 percentage of participants
|
0.7 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination
Any MAAEs
|
16.6 percentage of participants
|
20.8 percentage of participants
|
18.6 percentage of participants
|
17.1 percentage of participants
|
|
Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination
Any NOCDs
|
4.1 percentage of participants
|
7.6 percentage of participants
|
2.8 percentage of participants
|
2.7 percentage of participants
|
PRIMARY outcome
Timeframe: Day 208 to early termination (up to 396 days)Population: Booster Safety Set included all participants who received at least 1 dose of booster study vaccine (ARCT-021, ARCT-154, ARCT-165, or placebo) or had safety data collected in the period following booster administration.
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, resulted in a congenital anomaly or birth defect, or was an important medical event. An NOCD was defined as an AE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Treatment A
n=44 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=41 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=42 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=99 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination
Any SAEs
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination
Any MAAEs
|
11.4 percentage of participants
|
19.5 percentage of participants
|
11.9 percentage of participants
|
12.1 percentage of participants
|
|
Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination
Any NOCDs
|
2.3 percentage of participants
|
4.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1Population: Modified intent to treat (mITT) analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. The mITT analysis set was analyzed according to vaccine received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Outcome measures
| Measure |
Treatment A
n=131 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=140 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=134 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=141 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies Post Priming Vaccination
|
4.40 IU/mL
Interval 4.03 to 4.8
|
5.14 IU/mL
Interval 4.47 to 5.9
|
5.31 IU/mL
Interval 4.57 to 6.18
|
4.75 IU/mL
Interval 4.3 to 5.25
|
PRIMARY outcome
Timeframe: Day 56Population: mITT Analysis Set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. The mITT analysis set was analyzed according to vaccine received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Outcome measures
| Measure |
Treatment A
n=114 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=116 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=117 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=116 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
GMT of SARS-CoV-2 Neutralizing Antibodies Post Priming Vaccination
|
5.47 Titer
Interval 4.61 to 6.48
|
13.37 Titer
Interval 10.65 to 16.79
|
15.31 Titer
Interval 11.89 to 19.72
|
4.21 Titer
Interval 3.89 to 4.57
|
PRIMARY outcome
Timeframe: Day 208Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=35 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=37 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=49 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination
|
13.37 Titer
Interval 7.84 to 22.8
|
20.71 Titer
Interval 10.47 to 40.97
|
14.04 Titer
Interval 7.14 to 27.62
|
11.84 Titer
Interval 7.57 to 18.51
|
PRIMARY outcome
Timeframe: Day 236Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Outcome measures
| Measure |
Treatment A
n=40 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=35 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=35 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=34 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination
|
229.70 Titer
Interval 135.7 to 388.8
|
503.18 Titer
Interval 296.57 to 853.72
|
380.77 Titer
Interval 249.24 to 581.71
|
10.73 Titer
Interval 6.56 to 17.56
|
PRIMARY outcome
Timeframe: Day 56Population: mITT Analysis Set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. The mITT analysis set was analyzed according to vaccine received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
GMFR is reported as a ratio to baseline (Day 0).
Outcome measures
| Measure |
Treatment A
n=114 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=116 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=117 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=116 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Priming Vaccination
|
1.3 Ratio
Interval 1.1 to 1.6
|
2.7 Ratio
Interval 2.2 to 3.5
|
2.9 Ratio
Interval 2.2 to 3.7
|
0.9 Ratio
Interval 0.8 to 1.0
|
PRIMARY outcome
Timeframe: Day 208Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
GMFR is reported as a ratio to baseline (Day 0).
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=35 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=37 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=49 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination
|
2.4 Ratio
Interval 1.3 to 4.6
|
4.2 Ratio
Interval 2.1 to 8.3
|
3.0 Ratio
Interval 1.6 to 5.7
|
2.0 Ratio
Interval 1.5 to 2.8
|
PRIMARY outcome
Timeframe: Day 236Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
GMFR is reported as a ratio to baseline (Day 0).
Outcome measures
| Measure |
Treatment A
n=40 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=35 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=35 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=34 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
GMFR in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination
|
41.3 Ratio
Interval 22.0 to 77.7
|
100.8 Ratio
Interval 59.6 to 170.5
|
86.1 Ratio
Interval 58.8 to 126.1
|
1.7 Ratio
Interval 1.3 to 2.1
|
PRIMARY outcome
Timeframe: Baseline up to Day 56Population: mITT analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Outcome measures
| Measure |
Treatment A
n=114 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=116 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=117 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=116 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56
>=2-fold Increase from Baseline
|
15.8 percentage of participants
|
59.5 percentage of participants
|
62.4 percentage of participants
|
2.6 percentage of participants
|
|
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56
>=4-fold Increase from Baseline
|
8.8 percentage of participants
|
43.1 percentage of participants
|
42.7 percentage of participants
|
0.9 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 208Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=35 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=37 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=49 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208
>=2-fold Increase from Baseline
|
53.7 percentage of participants
|
74.3 percentage of participants
|
48.6 percentage of participants
|
53.1 percentage of participants
|
|
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208
>=4-fold Increase from Baseline
|
26.8 percentage of participants
|
25.7 percentage of participants
|
21.6 percentage of participants
|
14.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 236Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Outcome measures
| Measure |
Treatment A
n=40 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=35 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=35 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=34 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236
>=2-fold Increase from Baseline
|
90.0 percentage of participants
|
97.1 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
|
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236
>=4-fold Increase from Baseline
|
85.0 percentage of participants
|
94.3 percentage of participants
|
100 percentage of participants
|
8.8 percentage of participants
|
SECONDARY outcome
Timeframe: Days 0 and 56Population: mITT analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only and number analyzed signifies those participants who were evaluable at specified time points only.
Outcome measures
| Measure |
Treatment A
n=131 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=140 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=133 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=141 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination
Anti-N: Day 0
|
0.27 Binding antibody units/milliliters
Interval 0.21 to 0.35
|
0.26 Binding antibody units/milliliters
Interval 0.2 to 0.33
|
0.29 Binding antibody units/milliliters
Interval 0.22 to 0.37
|
0.29 Binding antibody units/milliliters
Interval 0.22 to 0.38
|
|
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination
Anti-N: Day 56
|
0.23 Binding antibody units/milliliters
Interval 0.17 to 0.3
|
0.22 Binding antibody units/milliliters
Interval 0.17 to 0.3
|
0.27 Binding antibody units/milliliters
Interval 0.2 to 0.36
|
0.23 Binding antibody units/milliliters
Interval 0.17 to 0.31
|
|
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination
Anti-RBD: Day 0
|
0.63 Binding antibody units/milliliters
Interval 0.5 to 0.8
|
0.58 Binding antibody units/milliliters
Interval 0.46 to 0.72
|
0.70 Binding antibody units/milliliters
Interval 0.53 to 0.93
|
0.56 Binding antibody units/milliliters
Interval 0.46 to 0.67
|
|
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination
Anti-RBD: Day 56
|
5.19 Binding antibody units/milliliters
Interval 3.85 to 7.01
|
22.94 Binding antibody units/milliliters
Interval 17.25 to 30.51
|
35.71 Binding antibody units/milliliters
Interval 26.33 to 48.42
|
0.55 Binding antibody units/milliliters
Interval 0.43 to 0.71
|
|
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination
Anti-S1: Day 0
|
0.40 Binding antibody units/milliliters
Interval 0.32 to 0.5
|
0.41 Binding antibody units/milliliters
Interval 0.33 to 0.51
|
0.53 Binding antibody units/milliliters
Interval 0.4 to 0.71
|
0.35 Binding antibody units/milliliters
Interval 0.28 to 0.42
|
|
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination
Anti-S1: Day 56
|
7.61 Binding antibody units/milliliters
Interval 5.93 to 9.78
|
25.91 Binding antibody units/milliliters
Interval 20.02 to 33.54
|
41.36 Binding antibody units/milliliters
Interval 32.59 to 52.49
|
0.34 Binding antibody units/milliliters
Interval 0.26 to 0.44
|
SECONDARY outcome
Timeframe: Day 208 and 236Population: Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only and number analyzed signifies those participants who were evaluable at specified time points only.
Outcome measures
| Measure |
Treatment A
n=41 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=35 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=36 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=49 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination
Anti- N: Day 208
|
0.39 Binding antibody units/milliliters
Interval 0.22 to 0.66
|
0.38 Binding antibody units/milliliters
Interval 0.22 to 0.66
|
0.43 Binding antibody units/milliliters
Interval 0.23 to 0.79
|
0.40 Binding antibody units/milliliters
Interval 0.24 to 0.67
|
|
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination
Anti-N: Day 236
|
0.67 Binding antibody units/milliliters
Interval 0.41 to 1.1
|
0.54 Binding antibody units/milliliters
Interval 0.34 to 0.85
|
0.73 Binding antibody units/milliliters
Interval 0.45 to 1.21
|
0.32 Binding antibody units/milliliters
Interval 0.18 to 0.58
|
|
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination
Anti- S1: Day 208
|
10.10 Binding antibody units/milliliters
Interval 5.42 to 18.82
|
17.22 Binding antibody units/milliliters
Interval 7.85 to 37.77
|
13.36 Binding antibody units/milliliters
Interval 6.44 to 27.72
|
9.13 Binding antibody units/milliliters
Interval 5.21 to 15.99
|
|
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination
Anti- S1: Day 236
|
236.46 Binding antibody units/milliliters
Interval 144.96 to 385.74
|
488.81 Binding antibody units/milliliters
Interval 284.81 to 838.92
|
441.16 Binding antibody units/milliliters
Interval 316.21 to 615.48
|
5.97 Binding antibody units/milliliters
Interval 3.11 to 11.46
|
|
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination
Anti- RBD: Day 208
|
10.29 Binding antibody units/milliliters
Interval 5.33 to 19.84
|
17.31 Binding antibody units/milliliters
Interval 7.23 to 41.42
|
12.81 Binding antibody units/milliliters
Interval 5.66 to 29.02
|
8.81 Binding antibody units/milliliters
Interval 4.73 to 16.41
|
|
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination
Anti- RBD: Day 236
|
258.97 Binding antibody units/milliliters
Interval 140.12 to 478.63
|
715.15 Binding antibody units/milliliters
Interval 394.23 to 1297.31
|
591.87 Binding antibody units/milliliters
Interval 397.34 to 881.64
|
5.38 Binding antibody units/milliliters
Interval 2.63 to 11.01
|
SECONDARY outcome
Timeframe: Day 56Population: mITT analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Outcome measures
| Measure |
Treatment A
n=114 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=115 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=117 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=116 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56
Anti-N
|
0.9 Ratio
Interval 0.8 to 0.9
|
0.9 Ratio
Interval 0.8 to 1.0
|
0.9 Ratio
Interval 0.8 to 1.0
|
0.9 Ratio
Interval 0.9 to 1.0
|
|
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56
Anti-RBD
|
8.6 Ratio
Interval 6.3 to 11.8
|
42.7 Ratio
Interval 32.0 to 57.0
|
48.7 Ratio
Interval 34.3 to 69.3
|
1.0 Ratio
Interval 0.9 to 1.1
|
|
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56
Anti-S1
|
19.8 Ratio
Interval 14.8 to 26.4
|
65.9 Ratio
Interval 50.3 to 86.5
|
77.7 Ratio
Interval 55.2 to 109.4
|
1.0 Ratio
Interval 0.8 to 1.1
|
SECONDARY outcome
Timeframe: Day 56Population: mITT analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Outcome measures
| Measure |
Treatment A
n=114 Participants
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=115 Participants
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=117 Participants
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=116 Participants
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels
Anti-N: >=2 Fold Increase From Baseline
|
1.8 percentage of participants
Interval 0.2 to 6.2
|
2.6 percentage of participants
Interval 0.5 to 7.4
|
1.7 percentage of participants
Interval 0.2 to 6.0
|
2.6 percentage of participants
Interval 0.5 to 7.4
|
|
Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels
Anti-N: >=4 Fold Increase From Baseline
|
0 percentage of participants
Interval 0.0 to 3.2
|
1.7 percentage of participants
Interval 0.2 to 6.1
|
0.9 percentage of participants
Interval 0.0 to 4.7
|
0 percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels
Anti-RBD: >=2 Fold Increase From Baseline
|
75.4 percentage of participants
Interval 66.5 to 83.0
|
96.5 percentage of participants
Interval 91.3 to 99.0
|
88.9 percentage of participants
Interval 81.7 to 93.9
|
3.4 percentage of participants
Interval 0.9 to 8.6
|
|
Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels
Anti-RBD: >=4 Fold Increase From Baseline
|
64.0 percentage of participants
Interval 54.5 to 72.8
|
92.2 percentage of participants
Interval 85.7 to 96.4
|
84.6 percentage of participants
Interval 76.8 to 90.6
|
0.9 percentage of participants
Interval 0.0 to 4.7
|
|
Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels
Anti-S1: >=2 Fold Increase From Baseline
|
90.4 percentage of participants
Interval 83.4 to 95.1
|
98.3 percentage of participants
Interval 93.9 to 99.8
|
95.7 percentage of participants
Interval 90.3 to 98.6
|
5.2 percentage of participants
Interval 1.9 to 10.9
|
|
Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels
Anti-S1: >=4 Fold Increase From Baseline
|
85.1 percentage of participants
Interval 77.2 to 91.1
|
96.5 percentage of participants
Interval 91.3 to 99.0
|
92.3 percentage of participants
Interval 85.9 to 96.4
|
0.9 percentage of participants
Interval 0.0 to 4.7
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Treatment B
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Treatment C
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Treatment D
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Treatment E1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Treatment F1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Treatment G1
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Treatment H1
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Treatment A - Reactogenicity Analysis
Serious events: 0 serious events
Other events: 113 other events
Deaths: 0 deaths
Treatment B - Reactogenicity Analysis
Serious events: 0 serious events
Other events: 107 other events
Deaths: 0 deaths
Treatment C - Reactogenicity Analysis
Serious events: 0 serious events
Other events: 120 other events
Deaths: 0 deaths
Treatment D - Reactogenicity Analysis
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Treatment E1 - Reactogenicity Analysis
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Treatment F1- Reactogenicity Analysis
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Treatment G1 - Reactogenicity Analysis
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Treatment H1 - Reactogenicity Analysis
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A
n=145 participants at risk
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=144 participants at risk
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=145 participants at risk
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=146 participants at risk
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment E1
n=44 participants at risk
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
|
Treatment F1
n=41 participants at risk
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
|
Treatment G1
n=42 participants at risk
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
|
Treatment H1
n=99 participants at risk
Participants in this group received placebo at Day 208.
|
Treatment A - Reactogenicity Analysis
n=142 participants at risk
Participants in this group received ARCT-021 7.5 mcg at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B - Reactogenicity Analysis
n=142 participants at risk
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C - Reactogenicity Analysis
n=144 participants at risk
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D - Reactogenicity Analysis
n=146 participants at risk
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment E1 - Reactogenicity Analysis
n=43 participants at risk
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
|
Treatment F1- Reactogenicity Analysis
n=38 participants at risk
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
|
Treatment G1 - Reactogenicity Analysis
n=38 participants at risk
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
|
Treatment H1 - Reactogenicity Analysis
n=39 participants at risk
Participants in this group received placebo at Day 208.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.69%
1/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.69%
1/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.69%
1/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.68%
1/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.69%
1/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.68%
1/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.68%
1/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary venous thrombosis
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.68%
1/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.68%
1/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
2.4%
1/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
Other adverse events
| Measure |
Treatment A
n=145 participants at risk
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B
n=144 participants at risk
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C
n=145 participants at risk
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D
n=146 participants at risk
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment E1
n=44 participants at risk
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
|
Treatment F1
n=41 participants at risk
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
|
Treatment G1
n=42 participants at risk
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
|
Treatment H1
n=99 participants at risk
Participants in this group received placebo at Day 208.
|
Treatment A - Reactogenicity Analysis
n=142 participants at risk
Participants in this group received ARCT-021 7.5 mcg at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment B - Reactogenicity Analysis
n=142 participants at risk
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment C - Reactogenicity Analysis
n=144 participants at risk
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment D - Reactogenicity Analysis
n=146 participants at risk
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
|
Treatment E1 - Reactogenicity Analysis
n=43 participants at risk
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
|
Treatment F1- Reactogenicity Analysis
n=38 participants at risk
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
|
Treatment G1 - Reactogenicity Analysis
n=38 participants at risk
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
|
Treatment H1 - Reactogenicity Analysis
n=39 participants at risk
Participants in this group received placebo at Day 208.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
4.8%
7/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
2.8%
4/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
7.6%
11/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
2.1%
3/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
13.6%
6/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
12.2%
5/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
11.9%
5/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
12.1%
12/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
4/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
4.9%
7/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.69%
1/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
1.4%
2/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
4.9%
2/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
2.4%
1/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
1.0%
1/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
4/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
3.4%
5/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
2.3%
1/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
7.1%
3/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
1.0%
1/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
4.5%
2/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
4.9%
2/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
7.1%
3/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
4.0%
4/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
6/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
1.4%
2/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
4.8%
7/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
4.8%
7/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
27.9%
12/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
7.9%
3/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
10.5%
4/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
2.6%
1/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
General disorders
Fatigue
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
69.8%
30/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
34.2%
13/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
50.0%
19/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
25.6%
10/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
48.8%
21/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
21.1%
8/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
31.6%
12/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
12.8%
5/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
62.8%
27/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
31.6%
12/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
42.1%
16/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
12.8%
5/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
3/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
1.4%
2/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.69%
1/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
2.7%
4/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.4%
5/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.69%
1/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
1.4%
2/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Nervous system disorders
Headache
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
60.5%
26/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
34.2%
13/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
31.6%
12/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
25.6%
10/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.8%
4/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.69%
1/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.68%
1/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Immune system disorders
Immunisation reaction
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
3.0%
3/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
General disorders
Injection site Pain
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
51.2%
22/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
36.8%
14/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
39.5%
15/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
5.1%
2/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
General disorders
Injection site Erythema
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
9.3%
4/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
7.9%
3/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
7.9%
3/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
2.6%
1/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
General disorders
Injection site Swelling
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
11.6%
5/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
5.3%
2/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
7.9%
3/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
General disorders
Injection site tenderness
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
81.4%
35/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
65.8%
25/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
73.7%
28/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
12.8%
5/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
General disorders
Fever
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
11.6%
5/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
5.3%
2/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
2.6%
1/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
General disorders
Chills
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
44.2%
19/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
18.4%
7/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
21.1%
8/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
7.7%
3/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
25.6%
11/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
18.4%
7/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
10.5%
4/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
10.3%
4/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
32.6%
14/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
10.5%
4/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
10.5%
4/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
2.6%
1/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/145 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/44 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/41 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/42 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/99 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/142 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/144 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/146 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
7.0%
3/43 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
2.6%
1/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/38 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
0.00%
0/39 • Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
|
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