Trial Outcomes & Findings for Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 64 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI) (NCT NCT04420221)
NCT ID: NCT04420221
Last Updated: 2025-05-08
Results Overview
The solicited administration site AE(s) assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (\>)100 millimeter (mm) diameter.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
226 participants
Primary outcome timeframe
Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
Results posted on
2025-05-08
Participant Flow
Participant milestones
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
105
|
89
|
|
Overall Study
Exposed Set
|
6
|
6
|
6
|
6
|
8
|
103
|
89
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
8
|
80
|
79
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
25
|
10
|
Reasons for withdrawal
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
20
|
5
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
|
Overall Study
Migrated / Moved from the Study Area
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 64 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI)
Baseline characteristics by cohort
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=6 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
n=6 Participants
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
n=8 Participants
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
n=105 Participants
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
n=89 Participants
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18 - 64 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
105 Participants
n=8 Participants
|
89 Participants
n=8 Participants
|
226 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
99 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
55 Participants
n=8 Participants
|
127 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
66 Participants
n=8 Participants
|
58 Participants
n=8 Participants
|
155 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
66 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)Population: The analysis was performed on Solicited Safety Set (SSS) which included all subjects who received at least 1 dose of the study treatment (Exposed Set) who have solicited safety data. Analysis is presented for Dose-escalation safety lead-in participants.
The solicited administration site AE(s) assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (\>)100 millimeter (mm) diameter.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=6 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
n=6 Participants
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
n=8 Participants
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Vaccination 1, Pain at injection site, Any
|
2 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Vaccination 1, Pain at injection site, Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Vaccination 1, Redness at injection site, Any
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Vaccination 1, Redness at injection site, >100 mm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Vaccination 1, Swelling at injection site, Any
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Vaccination 1, Swelling at injection site, >100 mm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Vaccination 2, Pain at injection site, Any
|
—
|
—
|
—
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Vaccination 2, Pain at injection site, Severe
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Vaccination 2, Redness at injection site, Any
|
—
|
—
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Vaccination 2, Redness at injection site, >100 mm
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Vaccination 2, Swelling at injection site, Any
|
—
|
—
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
Vaccination 2, Swelling at injection site, >100 mm
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)Population: The analysis was performed on Solicited Safety Set (SSS). Analysis is presented for PoP participants.
The solicited administration site AEs assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (\>)100 millimeter (mm) diameter.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=102 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=88 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Vaccination 1, Pain at injection site, Any
|
56 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Vaccination 1, Pain at injection site, Severe
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Vaccination 1, Redness at injection site, Any
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Vaccination 1, Redness at injection site, >100 mm
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Vaccination 1, Swelling at injection site, Any
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Vaccination 1, Swelling at injection site, >100 mm
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Vaccination 2, Pain at injection site, Any
|
42 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Vaccination 2, Pain at injection site, Severe
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Vaccination 2, Redness at injection site, Any
|
10 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Vaccination 2, Redness at injection site, >100 mm
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Vaccination 2, Swelling at injection site, Any
|
13 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
Vaccination 2, Swelling at injection site, >100 mm
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)Population: The analysis was performed on Solicited Safety Set (SSS). Analysis is presented for Dose-escalation safety lead-in participants.
The solicited systemic AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever. Any = any solicited systemic AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (\>) 40.0°C/104°F.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=6 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
n=6 Participants
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
n=8 Participants
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Abdominal Pain, Any
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Abdominal Pain, Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Diarrhea, Any
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Diarrhea, Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Fatigue, Any
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Fatigue, Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Fever, Any
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Fever (°C), > 40.0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Headache, Any
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Headache, Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Myalgia, Any
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Myalgia, Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Nausea, Any
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Nausea, Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Shivering, Any
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Shivering, Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Vomiting, Any
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Vomiting, Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Abdominal Pain, Any
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Abdominal Pain, Severe
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Diarrhea, Any
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Diarrhea, Severe
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Fatigue, Any
|
—
|
—
|
—
|
5 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Fatigue, Severe
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Fever, Any
|
—
|
—
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Fever (°C), > 40.0
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Headache, Any
|
—
|
—
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Headache, Severe
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Myalgia, Any
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Myalgia, Severe
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Nausea, Any
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Nausea, Severe
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Shivering, Any
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Shivering, Severe
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Vomiting, Any
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Vomiting, Severe
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)Population: The analysis was performed on Solicited Safety Set (SSS). Analysis is presented for PoP participants.
The solicited systemic AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever were assessed. Any = any solicited systemic AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (\>) 40.0°C/104°F.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=102 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=88 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Abdominal Pain, Any
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Abdominal Pain, Severe
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Diarrhea, Any
|
11 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Diarrhea, Severe
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Fatigue, Any
|
34 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Fatigue, Severe
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Fever, Any
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Fever (°C), > 40.0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Headache, Any
|
28 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Headache, Severe
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Myalgia, Any
|
16 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Myalgia, Severe
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Nausea, Any
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Nausea, Severe
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Shivering, Any
|
8 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Shivering, Severe
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Vomiting, Any
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 1, Vomiting, Severe
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Abdominal Pain, Any
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Abdominal Pain, Severe
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Diarrhea, Any
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Diarrhea, Severe
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Fatigue, Any
|
33 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Fatigue, Severe
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Fever, Any
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Fever (°C), > 40.0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Headache, Any
|
24 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Headache, Severe
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Myalgia, Any
|
15 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Myalgia, Severe
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Nausea, Any
|
11 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Nausea, Severe
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Shivering, Any
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Shivering, Severe
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Vomiting, Any
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Vaccination 2, Vomiting, Severe
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During 30 days after each vaccination (day of administration and 29 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)Population: The analysis was performed on the Unsolicited Safety Set (USS) which included all subjects who received at least 1 dose of the study treatment (Exposed Set) that report unsolicited AEs/report not having unsolicited AEs.
An unsolicited adverse event is defined as an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Any unsolicited AE, Grade 3 unsolicited AE, unsolicited AE causally related to the vaccination and Grade 3 unsolicited AE causally related to the vaccination were assessed. A grade 3 AE is an AE that prevents normal, everyday activities.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=6 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
n=6 Participants
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
n=8 Participants
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 2, At least one unsolicited adverse event
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 1, At least one grade 3 unsolicited adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 1, At least one grade 3 related unsolicited adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 1, At least one unsolicited adverse event
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 1, At least one related unsolicited adverse event
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 2, At least one related unsolicited adverse event
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 2, At least one grade 3 unsolicited adverse event
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 2, At least one grade 3 related unsolicited adverse event
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: During 30 days after each vaccination (day of administration and 29 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)Population: The analysis was performed on USS.
An unsolicited adverse event is defined as an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Any unsolicited AE, Grade 3 unsolicited AE, unsolicited AE causally related to the vaccination and Grade 3 unsolicited AE causally related to the vaccination were assessed. A grade 3 AE is an AE that prevents normal, everyday activities.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=103 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=89 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 1, At least one unsolicited adverse event
|
32 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 1, At least one related unsolicited adverse event
|
16 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 1, At least one grade 3 unsolicited adverse event
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 1, At least one grade 3 related unsolicited adverse event
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 2, At least one unsolicited adverse event
|
23 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 2, At least one related unsolicited adverse event
|
12 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 2, At least one grade 3 unsolicited adverse event
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
Vaccination 2, At least one grade 3 related unsolicited adverse event
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 366Population: The analysis was performed on the Exposed Set (ES) that included all subjects who received at least 1 dose of the study treatment. The allocation in a group is done in function of the administered treatment.
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=6 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
n=6 Participants
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
n=8 Participants
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Dose-escalation Safety lead-in: Number of Participants With Serious AEs (SAEs) up to 1 Year Post First Vaccination
At least one SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Serious AEs (SAEs) up to 1 Year Post First Vaccination
At least one serious related AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With Serious AEs (SAEs) up to 1 Year Post First Vaccination
Any Grade 3 SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 61 to Day 426 (post vaccination at Day 61)Population: The analysis was performed on ES. Only participants that received a second vaccination on Day 61 were included in this analysis.
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=2 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Dose-escalation Safety lead-in: Number of Participants With SAEs up to 1 Year Post Second Vaccination
At least one SAE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With SAEs up to 1 Year Post Second Vaccination
At least one serious related AE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Dose-escalation Safety lead-in: Number of Participants With SAEs up to 1 Year Post Second Vaccination
Any Grade 3 SAE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 426Population: The analysis was performed on ES. The allocation in a group is done in function of the administered treatment.
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=103 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=89 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
PoP: Number of Participants With SAEs
At least one SAE
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With SAEs
At least one serious related AE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
PoP: Number of Participants With SAEs
Any Grade 3 SAE
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 366Population: The analysis was performed on ES.
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=6 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
n=6 Participants
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
n=8 Participants
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Dose-escalation Safety lead-in: Number of Participants With Potential Immune-mediated Diseases (pIMDs) up to 1 Year Post First Vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 61 to Day 426 (post vaccination at Day 61)Population: The analysis was performed on ES. Only participants that received a second vaccination on Day 61 were included in this analysis.
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=2 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Dose-escalation Safety lead-in: Number of Participants With pIMDs up to 1 Year Post Second Vaccination
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 426Population: The analysis was performed on ES.
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=103 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=89 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
PoP: Number of Participants With Potential Immune-mediated Diseases (pIMDs)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: On Day 8 compared to Baseline (Day 1)Population: The analysis was performed on the Laboratory Safety Set that was a subset of the Unsolicited Safety Set. Only participants that had available data as per pre-assigned timepoints were included in this analysis.
The Biochemical parameters assessed were: Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and the Haematological parameters assessed were: Haemoglobin, white blood cells (WBC) decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: \<parameter\>,\<grade at baseline\>,\<grade at visit\> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=6 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
n=5 Participants
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
n=6 Participants
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
n=8 Participants
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
n=29 Participants
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
n=11 Participants
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
ALT, Grade 0, Grade 0
|
6 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
26 Participants
|
11 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
ALT, Grade 1, Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
ALT, Grade 1, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
AST, Grade 0, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
28 Participants
|
11 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
AST, Grade 0, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
AST, Grade 1, Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Creatinine, Unknown, Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Creatinine, Grade 0, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
29 Participants
|
10 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Eosinophils Increase, Grade 0, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
27 Participants
|
10 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Eosinophils Increase, Grade 1, Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Eosinophils Increase, Grade 1, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Haemoglobin Decrease, Grade 0, Grade 0
|
6 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
20 Participants
|
10 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Haemoglobin Decrease, Grade 0, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Haemoglobin Decrease, Grade 1, Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Haemoglobin Decrease, Grade 1, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Lymphocytes Decrease, Grade 0, Grade 0
|
6 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
29 Participants
|
11 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Lymphocytes Decrease, Grade 1, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Neutrophils Decrease, Grade 0, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
29 Participants
|
11 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Neutrophils Decrease, Grade 0, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Platelets Decrease, Grade 0, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
29 Participants
|
11 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
WBC Decrease, Grade 0, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
29 Participants
|
11 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
WBC Increase, Grade 0, Grade 0
|
6 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
26 Participants
|
11 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
WBC Increase, Grade 0, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
WBC Increase, Grade 1, Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: On Day 68 compared to Baseline (Day 61)Population: The analysis was performed on the Laboratory Safety Set. Only participants that had available data as per pre-assigned timepoints were included in this analysis.
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: \<parameter\>,\<grade at baseline\>,\<grade at visit\> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=2 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
n=28 Participants
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
n=11 Participants
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
ALT, Unknown, Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
ALT, Grade 0, Grade 0
|
6 Participants
|
2 Participants
|
26 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
ALT, Grade 1, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
AST, Unknown, Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
AST, Grade 0, Grade 0
|
6 Participants
|
2 Participants
|
26 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
AST, Grade 0, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
AST, Grade 1, Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Creatinine, Unknown, Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Creatinine, Grade 0, Grade 0
|
6 Participants
|
2 Participants
|
27 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Eosinophils Increase, Unknown, Grade 0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Eosinophils Increase, Grade 0, Grade 0
|
5 Participants
|
2 Participants
|
25 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Eosinophils Increase, Grade 0, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Eosinophils Increase, Grade 1, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Haemoglobin Decrease, Unknown, Grade 0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Haemoglobin Decrease, Grade 0, Grade 0
|
5 Participants
|
2 Participants
|
21 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Haemoglobin Decrease, Grade 0, Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Haemoglobin Decrease, Grade 1, Grade 0
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Haemoglobin Decrease, Grade 1, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Haemoglobin Decrease, Grade 1, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Lymphocytes Decrease, Unknown, Grade 0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Lymphocytes Decrease, Grade 0, Grade 0
|
5 Participants
|
2 Participants
|
26 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Lymphocytes Decrease, Grade 0, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Neutrophils Decrease, Unknown, Grade 0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Neutrophils Decrease, Grade 0, Grade 0
|
5 Participants
|
2 Participants
|
25 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Neutrophils Decrease, Grade 1, Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Neutrophils Decrease, Grade 1, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Platelets Decrease, Unknown, Grade 0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
Platelets Decrease, Grade 0, Grade 0
|
5 Participants
|
2 Participants
|
27 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
WBC Decrease, Unknown, Grade 0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
WBC Decrease, Grade 0, Grade 0
|
5 Participants
|
2 Participants
|
26 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
WBC Decrease, Grade 1, Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
WBC Increase, Unknown, Grade 0
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
WBC Increase, Grade 0, Grade 0
|
5 Participants
|
2 Participants
|
25 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
WBC Increase, Grade 0, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
WBC Increase, Grade 1, Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: On Day 8Population: The analysis was performed on the Laboratory Safety Set. Only participants that had available data as per pre-assigned timepoints were included in this analysis.
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: \<parameter\>,\<any grade at baseline\>,\<grade at visit\> (e.g. ALT, Any, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=6 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
n=5 Participants
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
n=6 Participants
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
n=8 Participants
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
n=29 Participants
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
n=11 Participants
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
ALT, Any, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
27 Participants
|
11 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
ALT, Any, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
AST, Any, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
28 Participants
|
11 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
AST, Any, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Creatinine, Any, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
29 Participants
|
11 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Eosinophils Increase, Any, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
27 Participants
|
11 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Eosinophils Increase, Any, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Haemoglobin Decrease, Any, Grade 0
|
6 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
22 Participants
|
10 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Haemoglobin Decrease, Any, Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Lymphocytes Decrease, Any, Grade 0
|
6 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
29 Participants
|
11 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Lymphocytes Decrease, Any, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Neutrophils Decrease, Any, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
29 Participants
|
11 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Neutrophils Decrease, Any, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Platelets Decrease, Any, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
29 Participants
|
11 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
WBC Decrease, Any, Grade 0
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
29 Participants
|
11 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
WBC Increase, Any, Grade 0
|
6 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
27 Participants
|
11 Participants
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
WBC Increase, Any, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: On Day 68Population: The analysis was performed on the Laboratory Safety Set. Only participants that had available data as per pre-assigned timepoints were included in this analysis.
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: \<parameter\>,\<any grade at baseline\>,\<grade at visit\> (e.g. ALT, Any, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=2 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
n=28 Participants
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
n=11 Participants
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
ALT, Any, Grade 0
|
6 Participants
|
2 Participants
|
27 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
ALT, Any, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
AST, Any, Grade 0
|
6 Participants
|
2 Participants
|
27 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
AST, Any, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Creatinine, Any, Grade 0
|
6 Participants
|
2 Participants
|
28 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Eosinophils Increase, Any, Grade 0
|
6 Participants
|
2 Participants
|
26 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Eosinophils Increase, Any, Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Haemoglobin Decrease, Any, Grade 0
|
6 Participants
|
2 Participants
|
24 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Haemoglobin Decrease, Any, Grade 1
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Haemoglobin Decrease, Any, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Lymphocytes Decrease, Any, Grade 0
|
6 Participants
|
2 Participants
|
27 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Lymphocytes Decrease, Any, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Neutrophils Decrease, Any, Grade 0
|
6 Participants
|
2 Participants
|
27 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Neutrophils Decrease, Any, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
Platelets Decrease, Any, Grade 0
|
6 Participants
|
2 Participants
|
28 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
WBC Decrease, Any, Grade 0
|
6 Participants
|
2 Participants
|
28 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
WBC Increase, Any, Grade 0
|
6 Participants
|
2 Participants
|
27 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
WBC Increase, Any, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 75 to Day 426Population: The analysis was performed on Interim analysis Proof of Principle (PoP) - modified Full Analysis Set (mFAS) which included all subjects who received full study treatment course to which they are randomised and have post-vaccination efficacy data.
An interim analysis was performed after 13 cases of recurrent SA-SSTI were reported following 14 days from the study intervention dose 2.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=38 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=21 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Culture Confirmed Case of Recurrent Staphylococcus Aureus (S. Aureus) Skin and Soft Tissue Infection (SSTI) - Interim Analysis
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 75 to Day 426Population: The analysis was performed on EoS analysis PoP mFAS.
After encountering futility at the interim analysis, an EOS analysis was conducted when at least one culture-confirmed case of recurrent SA-SSTI was identified 14 days after the second dose of the vaccine. For the final analysis, all the data collected by End of Study (EoS; Last Participant Last Visit) were analyzed for descriptive purposes.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=66 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=48 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Culture Confirmed Case of Recurrent S. Aureus SSTI - Final Analysis
|
14 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 15 to Day 426Population: The analysis was performed on the EOS PoP: Full Analysis Set (FAS) which included all subjects who received at least 1 dose of the study treatment and have post-vaccination efficacy data.
An EOS analysis was conducted when at least one culture-confirmed case of recurrent SA-SSTI was identified 14 days after the first dose of the vaccine. For the final analysis, all the data collected by End of Study (EoS; Last Participant Last Visit) were analyzed for descriptive purposes.
Outcome measures
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=103 Participants
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=89 Participants
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Culture Confirmed Case of Recurrent S. Aureus SSTI - Final Analysis
|
18 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose-escalation Safety Lead-in Epoch: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Proof of Principle (PoP): Full Dose Adj
Serious events: 5 serious events
Other events: 82 other events
Deaths: 0 deaths
PoP: Placebo
Serious events: 5 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 participants at risk
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=6 participants at risk
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
n=6 participants at risk
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
n=6 participants at risk
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
n=8 participants at risk
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
n=103 participants at risk
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
n=89 participants at risk
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Abscess limb
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Furuncle
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
Other adverse events
| Measure |
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
n=6 participants at risk
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
|
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
n=6 participants at risk
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
|
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
n=6 participants at risk
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
|
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
n=6 participants at risk
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
Dose-escalation Safety Lead-in Epoch: Placebo
n=8 participants at risk
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
|
Proof of Principle (PoP): Full Dose Adj
n=103 participants at risk
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
|
PoP: Placebo
n=89 participants at risk
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
3.9%
4/103 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
12.5%
1/8 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
9.7%
10/103 • Number of events 12 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
6.7%
6/89 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
13.6%
14/103 • Number of events 17 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
4.5%
4/89 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
33.3%
2/6 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
33.3%
2/6 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
12.5%
1/8 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
17.5%
18/103 • Number of events 23 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
11.2%
10/89 • Number of events 12 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
4.9%
5/103 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Chills
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
19.4%
20/103 • Number of events 22 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
6.7%
6/89 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
33.3%
2/6 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
50.0%
3/6 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
83.3%
5/6 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
25.0%
2/8 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
44.7%
46/103 • Number of events 70 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
27.0%
24/89 • Number of events 29 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Feeling hot
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Injection site erythema
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
50.0%
3/6 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
11.7%
12/103 • Number of events 16 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Injection site induration
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Injection site macule
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Injection site mass
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Injection site pain
|
33.3%
2/6 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
66.7%
4/6 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
83.3%
5/6 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
100.0%
6/6 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
12.5%
1/8 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
63.1%
65/103 • Number of events 114 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
14.6%
13/89 • Number of events 14 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Injection site rash
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Injection site swelling
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
50.0%
3/6 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
15.5%
16/103 • Number of events 23 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Pain
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
3.9%
4/103 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
50.0%
3/6 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
11.7%
12/103 • Number of events 12 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
3.4%
3/89 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
General disorders
Vaccination site erythema
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
3.9%
4/103 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
3.4%
3/89 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Ear infection staphylococcal
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Furuncle
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Impetigo
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
2.2%
2/89 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Skin graft failure
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.9%
2/103 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
33.3%
2/6 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
26.2%
27/103 • Number of events 32 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
11.2%
10/89 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.9%
2/103 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
50.0%
3/6 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
33.3%
2/6 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
50.0%
3/6 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
50.0%
4/8 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
38.8%
40/103 • Number of events 58 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
31.5%
28/89 • Number of events 37 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.9%
2/103 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
3.4%
3/89 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.9%
2/103 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.9%
2/103 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
2.2%
2/89 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/103 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
1.1%
1/89 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/6 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/8 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.97%
1/103 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
0.00%
0/89 • Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER